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Tiotropium/Salmeterol inhalationspulver ved KOL

18. juni 2026 opdateret af: Boehringer Ingelheim

1-årig undersøgelse, der sammenligner TioSal Combo-regimer versus enkeltstofterapier (Spiriva HandiHaler og Salmeterol PE-kapsel)

De primære mål med denne undersøgelse er at vurdere bronkodilatatorens effekt som bestemt af FEV1, virkningen på dyspnø som bestemt af BDI/TDI, virkningen på helbredsstatus som bestemt ved SGRQ og effekten på KOL-eksacerbationer

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

207

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1184.15.02057 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1184.15.02059 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1184.15.02055 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1184.15.02058 Boehringer Ingelheim Investigational Site
      • Scarborough Village, Ontario, Canada
        • 1184.15.02051 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1184.15.02053 Boehringer Ingelheim Investigational Site
    • Quebec
      • Longueuil, Quebec, Canada
        • 1184.15.02060 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1184.15.02056 Boehringer Ingelheim Investigational Site
  • Danmark
      • Aalborg, Danmark
        • 1184.15.45054 Boehringer Ingelheim Investigational Site
      • Kolding, Danmark
        • 1184.15.45052 Boehringer Ingelheim Investigational Site
      • Odense C, Danmark
        • 1184.15.45051 Boehringer Ingelheim Investigational Site
      • Silkeborg, Danmark
        • 1184.15.45053 Boehringer Ingelheim Investigational Site
  • Estland
      • Kohtla-Järve, Estland
        • 1184.15.37252 Boehringer Ingelheim Investigational Site
      • Tallinn, Estland
        • 1184.15.37251 Boehringer Ingelheim Investigational Site
  • Finland
      • Oulu, Finland
        • 1184.15.35852 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 1184.15.35851 Boehringer Ingelheim Investigational Site
  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater
        • 1184.15.01069 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, Forenede Stater
        • 1184.15.01071 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, Forenede Stater
        • 1184.15.01054 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Forenede Stater
        • 1184.15.01063 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Forenede Stater
        • 1184.15.01064 Boehringer Ingelheim Investigational Site
    • Georgia
      • Savannah, Georgia, Forenede Stater
        • 1184.15.01065 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater
        • 1184.15.01052 Boehringer Ingelheim Investigational Site
    • Missouri
      • St Louis, Missouri, Forenede Stater
        • 1184.15.01055 Boehringer Ingelheim Investigational Site
      • St Louis, Missouri, Forenede Stater
        • 1184.15.01058 Boehringer Ingelheim Investigational Site
      • St Louis, Missouri, Forenede Stater
        • 1184.15.01062 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Summit, New Jersey, Forenede Stater
        • 1184.15.01072 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
        • 1184.15.01053 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, Forenede Stater
        • 1184.15.01070 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, Forenede Stater
        • 1184.15.01057 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
        • 1184.15.01059 Boehringer Ingelheim Investigational Site
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater
        • 1184.15.01051 Boehringer Ingelheim Investigational Site
  • Frankrig
      • Marseille, Frankrig
        • 1184.15.3350A Boehringer Ingelheim Investigational Site
      • Nantes, Frankrig
        • 1184.15.3351A Boehringer Ingelheim Investigational Site
      • Paris, Frankrig
        • 1184.15.3352A Boehringer Ingelheim Investigational Site
  • Holland
      • Breda, Holland
        • 1184.15.31051 Boehringer Ingelheim Investigational Site
      • Utrecht, Holland
        • 1184.15.31054 Boehringer Ingelheim Investigational Site
      • Zutphen, Holland
        • 1184.15.31052 Boehringer Ingelheim Investigational Site
  • Italien
      • Florence, Italien
        • 1184.15.39051 Boehringer Ingelheim Investigational Site
  • Letland
      • Balvi, Letland
        • 1184.15.37154 Boehringer Ingelheim Investigational Site
      • Jelgava, Letland
        • 1184.15.37152 Boehringer Ingelheim Investigational Site
      • Tukums, Letland
        • 1184.15.37153 Boehringer Ingelheim Investigational Site
  • Litauen
      • Klaipėda, Litauen
        • 1184.15.37053 Boehringer Ingelheim Investigational Site
  • Slovakiet
      • Bratislava, Slovakiet
        • 1184.15.42153 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakiet
        • 1184.15.42154 Boehringer Ingelheim Investigational Site
  • Sverige
      • Boden, Sverige
        • 1184.15.46053 Boehringer Ingelheim Investigational Site
      • Stockholm, Sverige
        • 1184.15.46051 Boehringer Ingelheim Investigational Site
  • Sydafrika
      • Bellville, Sydafrika
        • 1184.15.27051
      • Cape Town, Sydafrika
        • 1184.15.27052
      • Somerset West, Sydafrika
        • 1184.15.27053
  • Sydkorea
      • Jeonju, Sydkorea
        • 1184.15.82051 Boehringer Ingelheim Investigational Site
      • Suwon, Sydkorea
        • 1184.15.82052 Boehringer Ingelheim Investigational Site
      • Wŏnju, Sydkorea
        • 1184.15.82053 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Aschaffenburg, Tyskland
        • 1184.15.49056 Boehringer Ingelheim Investigational Site
      • Frankfurt, Tyskland
        • 1184.15.49053 Boehringer Ingelheim Investigational Site
      • Gelnhausen, Tyskland
        • 1184.15.49057 Boehringer Ingelheim Investigational Site
      • Hanover, Tyskland
        • 1184.15.49052 Boehringer Ingelheim Investigational Site
      • Hanover, Tyskland
        • 1184.15.49058 Boehringer Ingelheim Investigational Site
  • Ungarn
      • Deszk, Ungarn
        • 1184.15.36055 Boehringer Ingelheim Investigational Site
      • Szarvas, Ungarn
        • 1184.15.36054 Boehringer Ingelheim Investigational Site
      • Szeged, Ungarn
        • 1184.15.36052 Boehringer Ingelheim Investigational Site
      • Érd, Ungarn
        • 1184.15.36053 Boehringer Ingelheim Investigational Site
  • Østrig
      • Gänserndorf, Østrig
        • 1184.15.43052 Boehringer Ingelheim Investigational Site
      • Vienna, Østrig
        • 1184.15.43053 Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Hoved:

Diagnose af KOL Post-bronkodilatator FEV1 <80% forudsagt og FEV1/FVC <70% forudsagt

Ekskluderingskriterier:

Hoved:

Væsentlige andre sygdomme end KOL. Seneste hjerteinfarkt Enhver ustabil eller livstruende hjertearytmi, der kræver indgriben eller ændring i lægemiddelbehandlingen i løbet af det seneste år Hospitalsindlæggelse for hjertesvigt i det seneste år Anamnese med astma

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FDC tiotropium / salmeterol (T+S_PE)
One fixed dose combination (FDC) capsule of inhalation powder containing 7.5 micrograms Tiotropium and 25 micrograms of salmeterol were administered orally once daily in the morning from blue HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered twice daily in the morning from the grey HandiHaler® device, and in the evening from blue HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
Medicin: Tiotropium/Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule
Aktiv komparator: tiotropium (Tio18GEL)
One dose gelatine capsule of inhalation powder containing 18 micrograms tiotropium was administered orally once daily in the morning from the grey HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered twice daily in the morning and evening from the blue HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
Medicin: Tiotropium
Tiotropium inhalationspulver, hård gelatinekapsel (Spiriva®)
Aktiv komparator: salmeterol (Salm25PE)
One dose polyethylene capsule of inhalation powder containing 25 micrograms salmeterol was administered orally twice daily in the morning and evening from the blue HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered once daily in the morning from the grey HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
Medicin: Salmeterol
Salmeterol inhalationspulver, hård PE kapsel
Aktiv komparator: FDC tiotropium / salmeterol + salmeterol (T+S_PE / S25PE)
One fixed dose combination (FDC) capsule of inhalation powder containing 7.5 micrograms tiotropium and 25 micrograms salmeterol was administered orally once daily in the morning from the blue HandiHaler® device and one dose of inhalation powder containing 25 micrograms salmeterol was administered once daily in the evening from the blue HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered once daily in the morning from the grey HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
Medicin: Salmeterol
Salmeterol inhalationspulver, hård PE kapsel
Medicin: Tiotropium/Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule
Placebo komparator: Placebo
One capsule of inhalation powder of placebo was administered daily in the morning from the blue and grey HandiHaler® device and in the evening from the blue HandiHaler® device for treatment duration of 12 weeks (Patients randomized into the placebo group will be re-assigned at random to one of the four active treatments (T+S_PE, Tio18GEL, Salm25PE, T+S_PE/S25PE) for the remaining 36 weeks of the 48-week study period.). The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
Medicin: Placebo
Placebo inhalationspulver, hård PE kapsel / hård gelatinekapsel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
Tidsramme: At baseline and week 12

Change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the end of the 12-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.

Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment.

Trough FEV1 response is defined as the change from baseline: Trough FEV1 response = Trough FEV1 - FEV1 (Baseline)
At baseline and week 12
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
Tidsramme: At baseline and week 24

Change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the end of the 24-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.

Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 min time point just prior to inhalation of the morning dose of randomised treatment.
At baseline and week 24
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 12-week Treatment Period
Tidsramme: At baseline and at week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8 hours (AUC0-8h) response at the end of the 12-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit.

Response = FEV1 AUC0-8h at week 12 - trough FEV1 at baseline.
At baseline and at week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 24-week Treatment Period
Tidsramme: At baseline and at week 24: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8h (AUC0-8h) response at the end of the 24-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit.

Response = FEV1 AUC0-8h at week 24 - trough FEV1 at baseline.
At baseline and at week 24: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Mahler Transition Dyspnoea Index (TDI) Focal Score at the End of the 12-week Treatment Period
Tidsramme: At the end of week 12

The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).

The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement.
At the end of week 12
Mahler Transition Dyspnoea Index (TDI) Focal Score at the End of the 24-week Treatment Period
Tidsramme: At the end of week 24

The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).

The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement.
At the end of week 24
St George Respiratory Questionnaire (SGRQ) Total Score at the End of the 24-week Treatment Period (Based Upon Pooled Data From 48-week Sister Studies 1184.14 and 1184.15)
Tidsramme: At the end of week 24

The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

The evaluation SGRQ was planned to be based upon pooled data from 48-week sister studies 1184.14 and 1184.15.
At the end of week 24
Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Within 48 Weeks
Tidsramme: Up to 12 weeks
Time from start of treatment to first moderate to severe chronic obstructive pulmonary disease (COPD) exacerbation within 48 weeks is presented.
Up to 12 weeks
Number of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Within 48 Weeks
Tidsramme: Up to 12 weeks.
Number of patients with moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations within 48 weeks is presented.
Up to 12 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response After 4, 36 and 48 Weeks Treatment Period
Tidsramme: At baseline and at week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8h (AUC0-8h) response after 4, 36 and 48 weeks treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit.

Response = FEV1 AUC0-8h at week 4, 36 or 48 - trough FEV1 at baseline.
At baseline and at week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) After 4, 36 and 48 Weeks Treatment Period
Tidsramme: At baseline and week 4.

Change from baseline in trough Forced Expiratory Volume in one second (FEV1) after 4, 36 and 48 weeks treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.

Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment.

Trough FEV1 response is defined as the change from baseline: Trough FEV1 response = Trough FEV1 - FEV1 (Baseline)
At baseline and week 4.
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) at Week 4, 12, 18, 24, 36 and 48
Tidsramme: At baseline and at week 4 and 12: within 3h after inhalation of the morning dose of randomised treatment.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Peak FEV1 is defined as the highest FEV1 reading observed within 3 hours after inhalation of the morning dose of randomised treatment. Peak FEV1 response is defined as the change from baseline: Peak FEV1 response = Peak FEV1 - FEV1 (Baseline)
At baseline and at week 4 and 12: within 3h after inhalation of the morning dose of randomised treatment.
The Forced Vital Capacity (FVC) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response After 4, 12, 24, 36 and 48 Weeks Treatment Period
Tidsramme: At baseline and at week 4 and 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC AUC0-8h is defined as the area under the FVC curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FVC was assigned to zero time. Trough FVC at baseline is defined as the pre-dose FVC measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit. Response = FVC AUC0-8h at week 4, 12, 24, 36 or 48 - trough FVC at baseline.
At baseline and at week 4 and 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Change From Baseline in Trough Forced Vital Capacity (FVC) After 4, 12, 24, 36 and 48 Weeks Treatment Period
Tidsramme: At baseline and week 4 and 12.
Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC is defined as the pre-dose FVC measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment. Trough FVC response is defined as the change from baseline: Trough FVC response = Trough FVC - FVC (Baseline)
At baseline and week 4 and 12.
Change From Baseline in Peak Forced Vital Capacity (FVC) at Week 4, 12, 18, 24, 36 and 48
Tidsramme: At baseline and at week 4 and 12: within 3 hours after inhalation of the morning dose of randomised treatment.
Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC is defined as the highest FVC reading observed within 3 hours after inhalation of the morning dose of randomised treatment. Peak FVC response is defined as the change from baseline: Peak FVC response = Peak FVC - FVC (Baseline)
At baseline and at week 4 and 12: within 3 hours after inhalation of the morning dose of randomised treatment.
Forced Expiratory Volume in One Second (FEV1) at Clinic Visits at the Individual Times on Week 4
Tidsramme: At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in one second (FEV1) at clinic visits at the individual times on week 4 is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.
At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in One Second (FEV1) at Clinic Visits at the Individual Times on Week 12
Tidsramme: At week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in one second (FEV1) at clinic visits at the individual times on week 12 is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.
At week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at Clinic Visits at the Individual Times on Week 4
Tidsramme: At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at clinic visits at the individual times on week 4 is presented. Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at Clinic Visits at the Individual Times on Week 12
Tidsramme: At week 12, at 10 min prior and 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at clinic visits at the individual times on week 12 is presented. Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
At week 12, at 10 min prior and 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Peak Expiratory Flow (PEF) Rate at Clinic Visits at the Individual Times on Week 4
Tidsramme: At week 4, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Peak expiratory flow (PEF) rate at clinic visits at the individual times on week 4 is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. PEF measurements was performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation were obtained within ± 5 minutes of the specified time-points. Measurements scheduled at 2-8 hours after inhalation were obtained within ± 10 minutes of the specified time-points.

PEF is defined as a person's maximum speed of expiration after a full inspiration.
At week 4, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Peak Expiratory Flow (PEF) Rate at Clinic Visits at the Individual Times on Week 12
Tidsramme: At week 12, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Peak expiratory flow (PEF) rate at clinic visits at the individual times on week 12 is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. PEF measurements will be performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation will be obtained within ± 5 minutes of the specified time-points.Measurements scheduled at 2-8 hours after inhalation will be obtained within ± 10 minutes of the specified time-points.
At week 12, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Weekly Mean Morning Pre-dose Peak Expiratory Flows (PEFs)
Tidsramme: At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean morning pre-dose peak expiratory flows (PEFs) is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. The pulmonary function test was obtained by spirometry. The best of three efforts was defined as the highest PEF. Patients did not take their morning study medications prior to each morning PEF measurement.
At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly Mean Evening Pre-dose Peak Expiratory Flows (PEFs)
Tidsramme: At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean evening pre-dose peak expiratory flows (PEFs) is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. The pulmonary function test was obtained by spirometry. The best of three efforts was defined as the highest PEF. Patients did not take their evening study medications prior to each evening PEF measurement.
At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Peak Expiratory Flow (PEF) Determined by Spirometry at Week 4, 12, 18, 24, 36 and 48
Tidsramme: At week 4 and 12: 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment.

Peak expiratory flow (PEF) are determined by spirometry at clinic visits (week 4, 12, 18, 24, 36 and 48) is presented.

Spirometry will begin between 07:00 and 10:00 a.m. PEF measurements will be performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation will be obtained within ± 5 minutes of the specified time-points.Measurements scheduled at 2-8 hours after inhalation will be obtained within ± 10 minutes of the specified time-points.
At week 4 and 12: 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment.
Weekly Mean Morning Pre-dose Forced Expiratory Volume in One Second (FEV1)
Tidsramme: At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean morning pre-dose Forced expiratory volume in one second (FEV1) is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements are performed individually at home and reported by the patient. It is measured by a spirometer. The best of three efforts was defined as the highest FEV1. Patients did not take their morning study medications prior to each morning FEV1 measurement.
At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly Mean Evening Pre-dose Forced Expiratory Volume in One Second (FEV1)
Tidsramme: At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean evening pre-dose Forced expiratory volume in one second (FEV1) is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements are performed individually at home and reported by the patient. It is measured by a spirometer. The best of three efforts was defined as the highest FEV1. Patients did not take their evening study medications prior to each evening FEV1 measurement.
At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly Mean Number Per Day (24 Hours Period) of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI)
Tidsramme: Weekly up to week 14: per day (24 hours period)

Weekly mean number per day of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented.

Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI).
Weekly up to week 14: per day (24 hours period)
Weekly Mean Number at Daytime of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI)
Tidsramme: Weekly up to week 14: at daytime (from morning dose till evening dose of study medication)

Weekly mean number at daytime of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented.

Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI).
Weekly up to week 14: at daytime (from morning dose till evening dose of study medication)
Weekly Mean Number at Nighttime of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI)
Tidsramme: Weekly up to week 14: at nighttime (from evening dose till morning dose of study medication)
Weekly mean number at nighttime of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented. Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI).
Weekly up to week 14: at nighttime (from evening dose till morning dose of study medication)
Weekly Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Nighttime Awakenings
Tidsramme: Per week, up to 14 weeks
Weekly mean number of chronic obstructive pulmonary disease (COPD)-related nighttime awakenings is presented.
Per week, up to 14 weeks
Mahler Transition Dyspnoea Index (TDI) Focal Score Collected After 4, 36 and 48 Weeks Treatment Period
Tidsramme: At week 4.

The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).

The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement.
At week 4.
Mahler Transition Dyspnoea Index (TDI) Domain Score - Functional Impairment Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period
Tidsramme: At the end of week 4 and 12.
The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).
At the end of week 4 and 12.
Mahler Transition Dyspnoea Index (TDI) Domain Score - Magnitude of Task Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period
Tidsramme: At the end of week 4 and 12.
The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. The Mahler Transition Dyspnoea Index (TDI) domain score - magnitude of task is based on the criteria of change in magnitude of task (What activities cause breathlessness now?) which causes breathlessness, ranging from grade -3 (major deterioration) to +3 (major improvement).
At the end of week 4 and 12.
Mahler Transition Dyspnoea Index (TDI) Domain Score - Magnitude of Effort Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period
Tidsramme: At the end of week 4 and 12.
The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. The Mahler Transition Dyspnoea Index (TDI) domain score - magnitude of effort is based on the criteria of change in magnitude of effort (Need to pause while performing activities?) which causes breathlessness, ranging from grade -3 (major deterioration) to +3 (major improvement).
At the end of week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Total Score Collected at 4, 12, 36 and 48 Weeks
Tidsramme: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Impact Domain Score Collected at 4, 12, 36 and 48 Weeks
Tidsramme: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The impact domain score is a part of the SGRQ that measures the impact of disease on daily life. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Activity Domain Score Collected at 4, 12, 36 and 48 Weeks
Tidsramme: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The activity domain score is a part of the SGRQ that measures the activity of the patient. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Symptoms Domain Score Collected at 4, 12, 36 and 48 Weeks
Tidsramme: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The symptoms domain score is a part of the SGRQ that measures the symptoms of the patient. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
Number of Patients With Adverse Events Within the 48-week Treatment Period
Tidsramme: From randomisation till end of treatment, up to 12 weeks.

Number of patients with adverse events within the 48-week treatment period is presented.

A patient may be counted in more than one seriousness criterion.
From randomisation till end of treatment, up to 12 weeks.
Number of Patients With Marked Changes in Vital Signs (Decrease) by Clinic Visit
Tidsramme: At baseline, week 4 and week 12.

Number of patients with marked changes in vital signs (decrease) by clinic visit is presented.

Vital signs: pulse rate and blood pressure (BP) (after five minutes rest in seated position) recorded pre-dose on each pulmonary function test day and in conjunction with spirometry for the first 3 hours post-dosing.

Systolic BP Decrease: Below 100 mmHg if not at that level at baseline and a decrease of greater than 10 mmHg below baseline.

Diastolic BP Decrease: Below 60 mmHg if not at that level at baseline and a decrease of greater than 10 mmHg below baseline.

Pulse rate Decrease: Below 60 bpm if not at that level at baseline and a decrease of greater than 10 bpm below baseline.
At baseline, week 4 and week 12.
Number of Patients With Marked Changes in Vital Signs (Increase) by Clinic Visit
Tidsramme: At baseline, week 4 and week 12.

Number of patients with marked changes in vital signs (increase) by clinic visit is presented.

Vital signs: pulse rate and blood pressure 8BP) (after five minutes rest in seated position) recorded pre-dose on each pulmonary function test-day and in conjunction with spirometry for the first 3 hours post-dosing.

Systolic BP Increase : An increase of 25 mmHg or more above baseline. Diastolic BP Increase: Above 90 mmHg and an increase of greater than 10 mmHg above baseline.

Pulse rate Increase : Greater than 100 bpm if not at that level at baseline and an increase greater than 10 % above baseline.
At baseline, week 4 and week 12.
Number of Patients With Abnormal Haematology at the End of the 12-week Treatment Period
Tidsramme: At the end of the 12-week treatment period.
Number of patients with abnormal haematology at the end of the 12-week treatment period is presented.
At the end of the 12-week treatment period.
Number of Patients With Abnormal Blood Chemistry at the End of the 12-week Treatment Period
Tidsramme: At the end of the 12-week treatment period.
Number of patients with abnormal blood chemistry at the end of the 12-week treatment period is presented.
At the end of the 12-week treatment period.
Number of Patients With Abnormal Urinalysis at the End of the 12-week Treatment Period
Tidsramme: At the end of the 12-week treatment period.
Number of patients with abnormal urinalysis at the end of the 12-week treatment period is presented.
At the end of the 12-week treatment period.
Vital Status of Randomised Patients
Tidsramme: Up to 48 weeks.
Vital status of randomised patients is presented.
Up to 48 weeks.
Number of Days in Hospital Within the 48-week Treatment Period
Tidsramme: Up to 12 weeks.
Number of days in hospital within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Unscheduled Health Care Provider Visits Within the 48-week Treatment Period
Tidsramme: Up to 12 weeks.
Number of unscheduled health care provider visits within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Emergency Room Visits Within the 48-week Treatment Period
Tidsramme: Up to 12 weeks.
Number of emergency room visits within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Days in Intensive Care Unit Within the 48-week Treatment Period
Tidsramme: Up to 12 weeks.
Number of days in intensive care unit within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Patients Receiving Concomitant Medication
Tidsramme: Up to 12 weeks.
Number of patients receiving concomitant medication is presented. Concomitant medication was observed for rerandomized placebo patients during placebo treatment and on-treatment periods.
Up to 12 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Efterforskere

  • Studiestol: Boehringer Ingelheim, Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2008

Primær færdiggørelse (Faktiske)

21. november 2008

Studieafslutning (Faktiske)

21. november 2008

Datoer for studieregistrering

Først indsendt

17. april 2008

Først indsendt, der opfyldte QC-kriterier

28. april 2008

Først opslået (Anslået)

29. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1184.15
  • 2007-005107-17 (EudraCT nummer: EudraCT)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD-delingsadgangskriterier

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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