Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
22. Juli 2011 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
96
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Berlin, Deutschland
- Novartis Investigative Site
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Hamburg, Deutschland
- Novartis Investigative Site
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Leipzig, Deutschland
- Novartis Investigative Site
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Mainz, Deutschland
- Novartis Investigative Site
-
-
-
-
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Beuvry, Frankreich
- Novartis Investigative Site
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Nantes, Frankreich
- Novartis Investigative Site
-
-
-
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Barcelona, Spanien
- Novartis Investigative Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Experimental: 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)
Andere Namen:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Novartis Pharmaceuticals, + 41 61 324 1111
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2008
Primärer Abschluss (Tatsächlich)
1. Juli 2008
Studienabschluss (Tatsächlich)
1. August 2008
Studienanmeldedaten
Zuerst eingereicht
1. Februar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Februar 2008
Zuerst gepostet (Schätzen)
14. Februar 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. August 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Juli 2011
Zuletzt verifiziert
1. Juli 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Lungenerkrankungen, obstruktive
- Lungenerkrankung, chronisch obstruktiv
- Physiologische Wirkungen von Arzneimitteln
- Adrenerge Wirkstoffe
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Adrenerge Agonisten
- Bronchodilatatoren
- Anti-Asthmatiker
- Atemwegsmittel
- Adrenerge Beta-2-Rezeptor-Agonisten
- Adrenerge Beta-Agonisten
- Salmeterol Xinafoat
Andere Studien-ID-Nummern
- CQAB149B2305
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