Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00615030
First received: February 1, 2008
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Indacaterol Drug: Salmeterol Drug: Placebo to Indacaterol Drug: Placebo to Salmeterol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons [ Time Frame: After 14 days of dosing ] [ Designated as safety issue: No ]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.
| Enrollment: | 96 |
| Study Start Date: | January 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Name: Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
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.
|
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Name: QAB149
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615030
Locations
| France | |
| Novartis Investigative Site | |
| Beuvry, France | |
| Novartis Investigative Site | |
| Nantes, France | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany | |
| Novartis Investigative Site | |
| Hamburg, Germany | |
| Novartis Investigative Site | |
| Leipzig, Germany | |
| Novartis Investigative Site | |
| Mainz, Germany | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Spain | |
Sponsors and Collaborators
Novartis
Investigators
| Principal Investigator: | Novartis Pharmaceuticals | + 41 61 324 1111 |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00615030 History of Changes |
| Other Study ID Numbers: | CQAB149B2305 |
| Study First Received: | February 1, 2008 |
| Results First Received: | July 22, 2011 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Novartis:
|
COPD, bronchodilator, long acting beta agonist, LABA |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Salmeterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013