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- Klinische proef 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 bijgewerkt door: 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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
74
Fase
- Fase 2
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: tiotropium + formoterol
|
|
Actieve vergelijker: tiotropium
|
|
Actieve vergelijker: formoterol
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Change in area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h)
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
Change in FEV1 AUC0-24h
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in FEV1 AUC12-24h
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in AUC of the forced vital capacity (FVC AUC0-12h)
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in FVC AUC0-24h
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in FVC AUC12-24h
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in peak FEV1 response
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in trough FEV1 response
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in peak FVC response
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in trough FVC response
Tijdsspanne: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Individual FEV1measurements at each time point
Tijdsspanne: up to 6 weeks
|
up to 6 weeks
|
|
Individual FVCmeasurements at each time point
Tijdsspanne: up to 6 weeks
|
up to 6 weeks
|
|
Peak expiratory flow rate (PEFR)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Number of patients with adverse events
Tijdsspanne: up to 23 weeks
|
up to 23 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2002
Primaire voltooiing (Werkelijk)
1 augustus 2002
Studieregistratiedata
Eerst ingediend
11 september 2014
Eerst ingediend dat voldeed aan de QC-criteria
11 september 2014
Eerst geplaatst (Schatting)
12 september 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
12 september 2014
Laatste update ingediend die voldeed aan QC-criteria
11 september 2014
Laatst geverifieerd
1 september 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Longziekten, obstructief
- Longziekten
- Longziekte, chronisch obstructief
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Parasympathicolytica
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Cholinerge antagonisten
- Cholinerge middelen
- Adrenerge agonisten
- Bronchusverwijdende middelen
- Anti-astmatische middelen
- Agenten van het ademhalingssysteem
- Adrenerge bèta-2-receptoragonisten
- Adrenerge beta-agonisten
- Tiotropiumbromide
- Formoterolfumaraat
Andere studie-ID-nummers
- 1184.3
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Tiotropium
-
Boehringer IngelheimVoltooidLongziekte, chronisch obstructiefBelgië, Denemarken, Finland, Duitsland, Nederland
-
Boehringer IngelheimVoltooid
-
Boehringer IngelheimVoltooid
-
Boehringer IngelheimVoltooidLongziekte, chronisch obstructiefVerenigde Staten, Argentinië, Oostenrijk, Canada, Duitsland, Nederland, Russische Federatie, Zweden
-
Boehringer IngelheimVoltooidLongziekte, chronisch obstructiefVerenigde Staten, Argentinië, Australië, Oostenrijk, België, Canada, Chili, Duitsland, Italië, Nieuw-Zeeland
-
Imperial College LondonBoehringer IngelheimVoltooidCOPD | LONGZIEKTEN, OBSTRUCTIEFVerenigd Koninkrijk
-
Verona Pharma plcIqvia Pty Ltd; LGC LimitedVoltooid
-
Virginia Commonwealth UniversityNational Heart, Lung, and Blood Institute (NHLBI)VoltooidHartfalen met normale ejectiefractieVerenigde Staten
-
Boehringer IngelheimVoltooidLongziekte, chronisch obstructiefVerenigde Staten, Argentinië, Canada, Finland, Frankrijk, Duitsland, Hongarije, Italië, Spanje, Verenigd Koninkrijk