Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
22. juli 2011 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
96
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beuvry, Frankrig
- Novartis Investigative Site
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Nantes, Frankrig
- Novartis Investigative Site
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Barcelona, Spanien
- Novartis Investigative Site
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Berlin, Tyskland
- Novartis Investigative Site
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Hamburg, Tyskland
- Novartis Investigative Site
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Leipzig, Tyskland
- Novartis Investigative Site
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Mainz, Tyskland
- Novartis Investigative Site
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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:
- 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
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: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
50 µg twice daily delivered via dry powder inhaler (DPI)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
|
Eksperimentel: 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)
Andre navne:
Placebo matching indacaterol was delivered via SDDPI.
Placebo matching salmeterol was delivered via DPI
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Novartis Pharmaceuticals, + 41 61 324 1111
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.
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. januar 2008
Primær færdiggørelse (Faktiske)
1. juli 2008
Studieafslutning (Faktiske)
1. august 2008
Datoer for studieregistrering
Først indsendt
1. februar 2008
Først indsendt, der opfyldte QC-kriterier
13. februar 2008
Først opslået (Skøn)
14. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. august 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2011
Sidst verificeret
1. juli 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Lungesygdomme
- Lungesygdomme, obstruktiv
- Lungesygdom, kronisk obstruktiv
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-2-receptoragonister
- Adrenerge beta-agonister
- Salmeterol Xinafoate
Andre undersøgelses-id-numre
- CQAB149B2305
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 .