- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02238119
Efficacy and Safety of Free Combination of Tiotropium + Formoterol Compared to Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
11. september 2014 opdateret af: Boehringer Ingelheim
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combination of Tiotropium Inhalation Powder Capsule (18 μg) + Formoterol Inhalation Powder Capsule (12 μg) QD, Tiotropium Inhalation Powder Capsule (18 μg) QD and Formoterol Inhalation Powder Capsule (12 μg) BID in Patients With COPD
Study to evaluate the lung function response to the free once-daily combination of tiotropium + formoterol compared to formoterol BID and tiotropium QD
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
74
Fase
- Fase 2
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
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All patients had to sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which included medication washout and restrictions
All patients had to have a diagnosis of chronic obstructive pulmonary disease and had to meet the following spirometric criteria:
- Patients had to have relatively stable moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
- Male or female patients 40 years of age or older
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes had to be excluded)
- Patients had to be able to perform technically acceptable pulmonary function tests and had to be able to maintain records (Patient Daily Diary Record) during the study period as required in the protocol
- Patients had to be able to inhale medication in a competent manner from the HandiHaler® device, the Blue Inhaler device and from a metered dose inhaler (MDI)
Exclusion Criteria:
- Patients with significant diseases other than COPD had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis if the abnormality defined a disease listed as an exclusion criterion
- All patients with an serum glutamate oxaloacetate transaminase (SGOT) > 80 IU/L, serum glutamate pyruvate transaminase (SGPT) > 80 IU/L, bilirubin > 17 μmol/L or creatinine > 110 μmol/L (males) / 95 μmol/L (females) had to be excluded regardless of clinical condition
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years
- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
Patients with prostatic hypertrophy controlled by medication were allowed
- Patients with known narrow-angle glaucoma
- Patients with a history of asthma, allergic rhinitis or who had a total blood eosinophil count ≥600 mm3
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- Patients with known active tuberculosis
- Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
- Patients who had undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons had to be evaluated as per exclusion criterion No. 1
- Patients who completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
- Patients who regularly used daytime oxygen therapy
- Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Patients who were treated with beta-blocker medications. Note: cardioselective beta blocker eye medications (e.g. Betoptic®) for treatment of non-narrow angle glaucoma were allowed
- Patients who were treated with oral beta-adrenergics
- Patients who were treated with cromolyn sodium or nedocromil sodium
- Patients who were treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No. 9
- Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Patients with known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other components of the inhalation capsule delivery systems
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous 3 months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g., Norplant®)
- Patients with previous participation (receipt of randomised treatment) in this study
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: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: tiotropium + formoterol
|
|
Aktiv komparator: tiotropium
|
|
Aktiv komparator: formoterol
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h)
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
Change in FEV1 AUC0-24h
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in FEV1 AUC12-24h
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in AUC of the forced vital capacity (FVC AUC0-12h)
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in FVC AUC0-24h
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in FVC AUC12-24h
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in peak FEV1 response
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in trough FEV1 response
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in peak FVC response
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in trough FVC response
Tidsramme: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Individual FEV1measurements at each time point
Tidsramme: up to 6 weeks
|
up to 6 weeks
|
|
Individual FVCmeasurements at each time point
Tidsramme: up to 6 weeks
|
up to 6 weeks
|
|
Peak expiratory flow rate (PEFR)
Tidsramme: weeks 4 to 6 of each treatment period
|
measured twice daily
|
weeks 4 to 6 of each treatment period
|
Number of inhalations of rescue salbutamol therapy used per day
Tidsramme: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Assessment of daytime COPD symptom score rated on a 6-point rating scale
Tidsramme: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Assessment of nighttime COPD symptom score rated on a 5-point rating scale
Tidsramme: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Number of patients with adverse events
Tidsramme: up to 23 weeks
|
up to 23 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
1. februar 2002
Primær færdiggørelse (Faktiske)
1. august 2002
Datoer for studieregistrering
Først indsendt
11. september 2014
Først indsendt, der opfyldte QC-kriterier
11. september 2014
Først opslået (Skøn)
12. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Lungesygdomme, obstruktiv
- Lungesygdomme
- Lungesygdom, kronisk obstruktiv
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Parasympatholytika
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge antagonister
- Kolinerge midler
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-2-receptoragonister
- Adrenerge beta-agonister
- Tiotropiumbromid
- Formoterolfumarat
Andre undersøgelses-id-numre
- 1184.3
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tiotropium
-
Boehringer IngelheimAfsluttetLungesygdom, kronisk obstruktivBelgien, Danmark, Finland, Tyskland, Holland
-
Boehringer IngelheimAfsluttet
-
Boehringer IngelheimAfsluttetLungesygdom, kronisk obstruktivForenede Stater, Argentina, Australien, Østrig, Belgien, Canada, Chile, Tyskland, Italien, New Zealand
-
Imperial College LondonBoehringer IngelheimAfsluttetKOL | LUNGESYGDOMME, OBSTRUKTIVEDet Forenede Kongerige
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Boehringer IngelheimAfsluttetLungesygdom, kronisk obstruktivForenede Stater, Argentina, Østrig, Canada, Tyskland, Holland, Den Russiske Føderation, Sverige
-
Novartis PharmaceuticalsTrukket tilbageKronisk obstruktiv lungesygdom (KOL)
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Boehringer IngelheimAfsluttetLungesygdom, kronisk obstruktivForenede Stater, Argentina, Australien, Østrig, Belgien, Brasilien, Bulgarien, Canada, Kina, Colombia, Kroatien, Danmark, Finland, Frankrig, Georgien, Tyskland, Grækenland, Guatemala, Ungarn, Indien, Irland, Israel, Italien, Korea, Republikken og mere
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Boehringer IngelheimAfsluttetLungesygdom, kronisk obstruktivForenede Stater, Argentina, Canada, Finland, Frankrig, Tyskland, Ungarn, Italien, Spanien, Det Forenede Kongerige
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Virginia Commonwealth UniversityNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetHjertesvigt med normal ejektionsfraktionForenede Stater