Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
22. července 2011 aktualizováno: Novartis
A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control
This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
96
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Beuvry, Francie
- Novartis Investigative Site
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Nantes, Francie
- Novartis Investigative Site
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Berlin, Německo
- Novartis Investigative Site
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Hamburg, Německo
- Novartis Investigative Site
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Leipzig, Německo
- Novartis Investigative Site
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Mainz, Německo
- Novartis Investigative Site
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Barcelona, Španělsko
- Novartis Investigative Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion criteria:
- Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- Co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%
Exclusion criteria:
- Pregnant or lactating females
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
- Patients requiring long term oxygen therapy (>15 h a day)
- Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
- Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
- Patients with history of asthma (with further criteria)
- Patients with Type I or uncontrolled type II diabetes.
- Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
- Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
- Patient with a history with long QT syndrome or whose QTc interval is prolonged
- Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
- Patients who have had treatment with an investigational drug (with further criteria)
- Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
- Patients with known history of non compliance to medication
- Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements
Other protocol-defined inclusion/exclusion criteria may apply
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Indacaterol Morning,Indacaterol Evening, Salmeterol
In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI).
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
In period III, Salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Indacaterol Evening,Indacaterol Morning, Placebo
In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Salmeterol, Placebo, Indacaterol Morning
In period I, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI.
In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Placebo, Salmeterol, Indacaterol Evening
In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI).
One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI.
In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Indacaterol Morning, Placebo, Indacaterol Evening
In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Indacaterol Evening,Salmeterol, Indacaterol Morning
In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
In period II, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI.
In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Salmeterol, Indacaterol Evening, Placebo
In period I, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI.
In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Placebo, Indacaterol Morning, Salmeterol
In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
In period III, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Indacaterol Morning, Salmeterol, Placebo
In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
In period II, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI.
In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Indacaterol Evening, Placebo, Salmeterol
In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry powder inhaler DPI.
In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
In period III, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Salmeterol, Indacaterol Morning, Indacaterol Evening
In period I, salmeterol 50 μg twice daily delivered via DPI.
One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI.
In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
50 µg twice daily delivered via dry powder inhaler (DPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimentální: Placebo, Indacaterol Evening, Indacaterol Morning
In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI.
In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI.
Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI.
In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI.
Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI.
Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.
The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
|
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Ostatní jména:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Časové okno: After 14 days of treatment
|
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period. |
After 14 days of treatment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Časové okno: After 14 days of dosing
|
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period.
On the morning and evening of Day 15 trough FEV1 (i.e.
mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed.
An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate.
The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
|
After 14 days of dosing
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Novartis Pharmaceuticals, + 41 61 324 1111
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2008
Primární dokončení (Aktuální)
1. července 2008
Dokončení studie (Aktuální)
1. srpna 2008
Termíny zápisu do studia
První předloženo
1. února 2008
První předloženo, které splnilo kritéria kontroly kvality
13. února 2008
První zveřejněno (Odhad)
14. února 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
17. srpna 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. července 2011
Naposledy ověřeno
1. července 2011
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Plicní onemocnění
- Plicní onemocnění, obstrukční
- Plicní onemocnění, chronická obstrukční
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Autonomní agenti
- Agenti periferního nervového systému
- Adrenergní agonisté
- Bronchodilatační činidla
- Antiastmatická činidla
- Agenti dýchacího systému
- Agonisté adrenergních beta-2 receptorů
- Adrenergní beta-agonisté
- Salmeterol Xinafoát
Další identifikační čísla studie
- CQAB149B2305
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .