Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT01089127

First received: March 17, 2010

Last updated: July 22, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 17, 2010

Last Updated Date

July 22, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15) [ Time Frame: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15) ] [ Designated as safety issue: No ]

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Original Primary Outcome Measures ^ICMJE

Trough forced expiratory volume in 1 second (FEV1) [ Time Frame: After 14 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01089127 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 [ Time Frame: 24 hours post-dose on Day 2 ] [ Designated as safety issue: No ]

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Original Secondary Outcome Measures ^ICMJE

Trough FEV1 [ Time Frame: After 1 day ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

Official Title ^ICMJE

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control

Brief Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Salmeterol 50 μg
Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Study Arm (s)

Experimental: Indacaterol 18.75 μg
Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Interventions:
- Drug: Indacaterol
- Drug: Placebo to salmeterol
Experimental: Indacaterol 37.5 μg
Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Interventions:
- Drug: Indacaterol
- Drug: Placebo to salmeterol
Experimental: Indacaterol 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Interventions:
- Drug: Indacaterol
- Drug: Placebo to salmeterol
Experimental: Indacaterol 150 μg
Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Interventions:
- Drug: Indacaterol
- Drug: Placebo to salmeterol
Active Comparator: Salmeterol 50 μg
Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Interventions:
- Drug: Salmeterol 50 μg
- Drug: Placebo to indacaterol
Placebo Comparator: Placebo
Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Interventions:
- Drug: Placebo to indacaterol
- Drug: Placebo to salmeterol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

552

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:
1. Smoking history of at least 10 pack-years
2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion criteria:

Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01089127

Other Study ID Numbers ^ICMJE

CQAB149B2356

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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