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En undersøgelse af patienter med kronisk obstruktiv lungesygdom (FUTURE)

24. juni 2026 opdateret af: Chiesi Farmaceutici S.p.A.

En 12-ugers, multicenter, multinational, randomiseret, dobbeltblind, dobbeltdummy, 2-arm parallel gruppeundersøgelse, der sammenligner effektiviteten og sikkerheden af ​​Foster® 100/6 (Beclomethason Dipropionate 100 µg Plus Formoterol 6 µg/aktivering), 2 Pust b.i.d., Versus Seretide® 500/50 (Fluticason 500 µg Plus Salmeterol 50 µg/aktivering), 1 inhalation b.i.d. hos patienter med kronisk obstruktiv lungesygdom

Formålet med nærværende undersøgelse er at bestemme virkningerne på sundhedsstatus og spirometriske værdier af Foster® 100/6 (to pust b.i.d.) versus Seretide® 500/50 (én inhalation b.i.d.) over en 12-ugers behandlingsperiode i kronisk obstruktiv behandling. Patienter med lungesygdomme (KOL).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Kronisk obstruktiv lungesygdom (KOL) er en uhelbredelig, invaliderende og progressiv sygdom, der kan være dødelig. Den nylige Global Burden of Disease-undersøgelse rangerer KOL som den 6. hyppigste dødsårsag og den 12. største årsag til sygelighed på verdensplan. Desuden indikerer tendenser i brugen af ​​medicinske ressourcer, at de økonomiske omkostninger ved KOL fortsætter med at stige i direkte relation til den aldrende befolkning, stigningen i forekomsten af ​​sygdomme og omkostningerne ved nye og eksisterende medicinske og offentlige sundhedsinterventioner.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

419

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Aarhus, Danmark
        • Aarhus University Hospital
      • Copenhagen, Danmark
        • Bispebjerg Hospital
      • Copenhagen, Danmark
        • Dept. of Cardiology and Respiratory Medicine
      • Gentofte Municipality, Danmark
        • Gentofte Hospital
      • Odense, Danmark
        • Odense University Hospital
  • Det Forenede Kongerige
      • Belfast, Det Forenede Kongerige
        • Belfast City Hospital
      • London, Det Forenede Kongerige
        • Kings College Hospital
      • Newcastle, Det Forenede Kongerige
        • Freeman Hospital
  • Frankrig
      • Toulon, Frankrig
        • Centre Hospitalier
  • Italien
      • Bologna, Italien
        • Ospedale Sant'Orsola-Malpighi
      • Catania, Italien
        • A.O. Policlinico
      • Monza, Italien
        • A.O. S. Gerardo
      • Naples, Italien
        • Azienda Ospedaliera Monaldi
      • Pisa, Italien
        • Universita di Pisa
      • Roma, Italien
        • IRCCS San Raffaele La Pisana
      • Rome, Italien, 00161
        • Policlinico Umberto I - VIII Padiglione
  • Polen
      • Gdansk, Polen
        • NZOZ "Non Nocere"
      • Koszalin, Polen
        • Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
      • Krakow, Polen
        • Szpital Uniwersytecki w Krakowie
      • Krakow, Polen
        • Szpital Specjalistyczny im Jana Pawła II
      • Lodz, Polen
        • Prywatny Gabinet Specjalistyczny
      • Szczecin, Polen
        • Samodzielny Publiczny Szpital Kliniczny
      • Warsaw, Polen
        • Chorób Płuc
      • Warsaw, Polen
        • Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
      • Warsaw, Polen
        • Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
      • Warsaw, Polen
        • Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
      • Wroclaw, Polen
        • DOBROSTAN - Gabinety Lekarskie
      • Wroclaw, Polen
        • NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
      • Zgierz, Polen
        • Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
  • Slovakiet
      • Humenné, Slovakiet
        • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
      • Nové Zámky, Slovakiet
        • Diunea, sro. Ambulancia PaF
      • Ostrov, Slovakiet
        • ALERGOIMUNO s.r.o
      • Poprad, Slovakiet
        • Pľúcna ambulancia, Poliklinika ADUS
      • Prešov, Slovakiet
        • PULMO, s.r.o
      • Prievidza, Slovakiet
        • PNEUMO-MED, s.r.o
      • Spišská Nová Ves, Slovakiet
        • Pľúcna ambulancia, Hrebenár s.r.o
      • Trnava, Slovakiet
        • PNEUMO-CENTRUM, s.r.o, Poliklinika
  • Spanien
      • Barcelona, Spanien
        • Hospital Del Mar
      • Sabadell, Spanien
        • Hospital Parc Tauli
      • Vic, Spanien
        • Hospital General Vic
  • Tyrkiet (Türkiye)
      • Adana, Tyrkiet (Türkiye)
        • Çukurova Üniversitesi
      • Antalya, Tyrkiet (Türkiye)
        • Akdeniz Universitesi
      • Antalya, Tyrkiet (Türkiye)
        • Bilim Üniversitesi
      • Bornova, Tyrkiet (Türkiye)
        • Ege Üniversitesi
      • Bursa, Tyrkiet (Türkiye)
        • Uludağ Üniversitesi
      • Gaziantep, Tyrkiet (Türkiye)
        • Gaziantep Üniversitesi
      • Istanbul, Tyrkiet (Türkiye)
        • Fatih Üniversitesi
      • Istanbul, Tyrkiet (Türkiye)
        • Marmara Üniversitesi
      • Izmir, Tyrkiet (Türkiye)
        • Dokuz Eylul Universitesi
      • Kayseri, Tyrkiet (Türkiye)
        • Erciyes Üniversitesi
  • Tyskland
      • Berlin, Tyskland
        • Praxis Dr. Jorg Kampschulte
      • Leipzig, Tyskland
        • Praxis Dr. Jörg Winkler
      • Lübeck, Tyskland
        • KLB Healthresearch
      • Lübeck, Tyskland
        • KLD Helthreseach
      • Magdeburg, Tyskland
        • SMO.MD GmbH Zentrum für Klinische Studien
      • Saarbrücken, Tyskland
        • Pneumologische Gemeinschaftspraxis Saarbrücken
      • Wedel, Tyskland
        • Fachinternistische Gemeinschafts
      • Wiesloch, Tyskland
        • Pneumologische Praxis Dr Redlich
      • Wuppertal, Tyskland
        • Gemeinschaftspraxis für Pneumologie
  • Ungarn
      • Balassagyarmat, Ungarn
        • Dr. Kenessey Albert Kórház - Rendelőintézet
      • Budapest, Ungarn
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
      • Békés, Ungarn
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Debrecen, Ungarn
        • Centrum-Tüdőgyógyászati Klinika
      • Kecskemét, Ungarn
        • Bács-Kiskun Megeyi Önkormanyzat...
      • Mosonmagyaróvár, Ungarn
        • Karolina Kórház és Rendelőintézet Tüdőgyógyászat
      • Nyíregyháza, Ungarn
        • Jósa András Hospital
      • Nyíregyháza, Ungarn
        • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
      • Szigetszentmiklös, Ungarn
        • Chiesi Clinical Centre Szigetszentmiklös

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:

  1. Mandlige eller kvindelige patienter i alderen ≥ 40 år, som har underskrevet en informeret samtykkeformular forud for påbegyndelse af en undersøgelsesrelateret procedure, eller når skriftligt informeret samtykke er indhentet af en juridisk repræsentant.

  2. Ambulante patienter med diagnosen KOL og herunder:

    1. Rygehistorie på mindst 10 pakkeår defineret som [(antal cigaretter røget pr. dag) x (antal år med rygning) / 20], både nuværende og tidligere rygere er berettigede.
    2. Brug af bronkodilatatorer inden for de sidste 2 måneder til besøg 1.
    3. Post-bronkodilatator FEV1 < 60 % af den forudsagte normalværdi.
    4. Post-bronkodilatator FEV1/FVC < 0,7.
    5. En ≥ 5 % respons på en reversibilitetstest.
    6. En baseline Dyspnoea Index (BDI) fokal score mindre eller lig med 10 (skal også opfyldes ved besøg 2).
  3. Anamnese med ikke mere end én KOL-eksacerbation inden for de foregående 12 måneder (uden at tage højde for de sidste 2 måneder) til besøg 1.
  4. En samarbejdsorienteret holdning og evne til at blive trænet til korrekt brug af pMDI og DPI (Accuhaler®, cirkulært støbt plastinhalator) inhalatorer.

Vigtigste ekskluderingskriterier:

  1. Klinisk relevante luftvejslidelser.
  2. Nuværende diagnose af astma eller andre luftvejslidelser end KOL.
  3. Klinisk signifikante laboratorie- og EKG-abnormiteter, der indikerer en signifikant eller ustabil samtidig sygdom, som kan påvirke gennemførligheden af ​​resultaterne af undersøgelsen ifølge investigatorens vurdering.
  4. Patienter med KOL-eksacerbation i de 2 måneder før screening og i undersøgelsesperioden.
  5. Patienter, der har behov for langvarig (mindst 12 timer dagligt) iltbehandling for kronisk hypoxæmi.
  6. Patienter behandlet med depotkortikosteroider i de 2 måneder forud for besøg 1 og i indkøringsperioden.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Foster®
Participants received 2 puffs of Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI twice daily (BID), resulting in a total daily dose of beclomethasone dipropionate 400 μg plus formoterol 24 μg, for a duration of 12 weeks. To ensure blinding, participants received one inhalation of placebo matching Seretide® Accuhaler® via a inhaler BID, for a duration of 12 weeks.
Medicin: Beclomethasone Dipropionate - Formoterol
Administered via a pressurized metered-dose inhaler
Andre navne:
  • Foster
Aktiv komparator: Seretide® Accuhaler®
Participants received one inhalation of Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation) administered via inhaler, BID resulting in a total daily dose of fluticasone 1000 μg plus salmeterol 100 μg, for a duration of 12 weeks. To ensure blinding, participants receieved two puffs of placebo matching Foster® via pMDI, BID for a duration of 12 weeks.
Medicin: Fluticasone - Salmeterol
Administered via a pressurized metered-dose inhaler
Andre navne:
  • Seretide Accuhaler®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1
Tidsramme: on Day 1 (V2)
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 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation
on Day 1 (V2)
Transition Dyspnoea Index (TDI) Score at Day 84
Tidsramme: Day 84 (V5)

TDI has three domains as follows:

  1. Functional impairment, which determines the impact of breathlessness on the ability to carry out activities;
  2. Magnitude of task, which determines the type of task that causes breathlessness;
  3. Magnitude of effort, which establishes the level of effort that results in breathlessness

The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement).

Adjusted means were reported.
Day 84 (V5)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
Tidsramme: on Day 84 (V5)
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 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.
on Day 84 (V5)
AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84
Tidsramme: on Day 84 (V5)
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 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.
on Day 84 (V5)
Change From Baseline (CFB) in Pre-dose Morning FEV1
Tidsramme: Weeks 4, 8 and 12
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 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
Weeks 4, 8 and 12
Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)
Tidsramme: Weeks 4, 8 and 12
FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.
Weeks 4, 8 and 12
Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
Tidsramme: 5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
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 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
Tidsramme: at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
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 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.
at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake
Tidsramme: at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.
at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
Change From Baseline to Each Two-Week Period in COPD Symptom Scores
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • the ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

Reported values (in form of adjusted means) reflect a percentage (%).

% of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days
Tidsramme: Baseline, Weeks 1 through 12

COPD symptom scores consists of following 6 items recorded by the participants in diary.

  • ability to perform the usual daily activities;
  • breathlessness over the previous 24h;
  • waking at night due to respiratory symptoms;
  • breathlessness on rising;
  • cough over the previous 24h;
  • sputum production over the previous 24h.

Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

% of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.
Baseline, Weeks 1 through 12
Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Number of rescue salbutamol puffs per day were recorded in the diary. Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period. Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period. Adjusted means were reported.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days
Tidsramme: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

A rescue medication-free day is a day with number of puffs of rescue medication = 0.

Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

% of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)*100.
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days
Tidsramme: at week 12 (V5)

A rescue medication-free day is a day with number of puffs of rescue medication = 0.

Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

% of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)*100.
at week 12 (V5)
Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores
Tidsramme: at Week 12 (V5)

SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains:

  • Symptoms, which evaluates the frequency and severity of respiratory issues like coughing, sputum production, and breathlessness;
  • Activity, which measures limitations in physical activities due to breathlessness;
  • Impacts, which examines psychological and social effects, including feelings of stigma, loss of control, and daily life disruption.

Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health).
at Week 12 (V5)
Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)
Tidsramme: Week 12 (V5), pre-dose and post-dose
The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start. The longer distance covered, the better the outcome.
Week 12 (V5), pre-dose and post-dose
Change From Pre-dose in Post-dose Distance Walked (6MWT)
Tidsramme: on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start.
on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
Number of Participants With COPD Exacerbations From Week 0 Through Week 12
Tidsramme: Week 12
A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention [leading to prescriptions of systemic corticosteroids (at least 3 days)] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".
Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: From first dose of study drug until end of the treatment (up to 84 days)

AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.

Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense.
From first dose of study drug until end of the treatment (up to 84 days)

Samarbejdspartnere og efterforskere

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

Sponsor

Chiesi Farmaceutici S.p.A.

Efterforskere

  • Ledende efterforsker: Dave Singh, MD, The Medicine Evaluation Unit - Manchester, UK
  • Ledende efterforsker: Jorgen Vestbo, MD, Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

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.

Generelle publikationer

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)

12. april 2011

Primær færdiggørelse (Faktiske)

13. marts 2012

Studieafslutning (Faktiske)

13. marts 2012

Datoer for studieregistrering

Først indsendt

19. november 2010

Først indsendt, der opfyldte QC-kriterier

19. november 2010

Først opslået (Anslået)

22. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCD-0910-PR-0021
  • 2009-014410-10 (EudraCT nummer)

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