12-week Efficacy of Indacaterol

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072448
• Other study ID #: CQAB149B2354
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2010
• Last updated: July 22, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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:

• Smoking history of at least 10 pack-years

• Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and = 30% of the predicted normal value

• 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 co-morbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 75 µg
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
• Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Locations

Country	Name	City	State
United States	Novartis Investigator Site	Abingdon	Virginia
United States	Novartis Investigative Site	Bangor	Maine
United States	Novartis Investigative Site	Beaver	Pennsylvania
United States	Novartis Investigator Site	Bellevue	Nebraska
United States	Novartis Investigator Site	Buena Park	California
United States	Novartis Investigator Site	Champaign	Illinois
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Clarkston	Michigan
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigator Site	Corsicana	Texas
United States	Novartis Investigator Site	Couer D'Alene	Idaho
United States	Novartis Investigator Site	Covington	Louisiana
United States	Novartis Investigator Site	Downers Grove	Illinois
United States	Novartis Investigative Site	Edina	Minnesota
United States	Novartis Investigator Site	Encinitas	California
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigative Site	Flint	Michigan
United States	Novartis Investigator Site	Florissant	Missouri
United States	Novartis Investigator Site	Fort Worth	Texas
United States	Novartis Investigator Site	Fountain Valley	California
United States	Novartis Investigative Site	Gaffney	South Carolina
United States	Novartis Investigative site	Greer	South Carolina
United States	Novartis Investigator Site	Henderson	Nevada
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative site	Lexington	Kentucky
United States	Novartis Investigator Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Livonia	Michigan
United States	Novartis Investigator Site	Los Angeles	California
United States	Novartis Investigator Site	Medford	Oregon
United States	Novartis Investigator Site	Metaire	Louisiana
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	New Brunswick	New Jersey
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	Ocean	New Jersey
United States	Novartis Investigator Site	Omaha	Nebraska
United States	Novartis Investigator Site	Ozark	Missouri
United States	Novartis Investigator Site	Pahrump	Nevada
United States	Novartis Investigator Site	Peoria	Arizona
United States	Novartis Investigator Site	Pine Bluff	Arkansas
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Plymouth	Minnesota
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigative Site	River Forest	Illinois
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Salisbury	North Carolina
United States	Novartis Investigator Site	Salt Lake City	Utah
United States	Novartis Investigator Site	San Diego	California
United States	Novartis Investigator Site	San Diego	California
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Seneca	South Carolina
United States	Novartis Investigator Site	Skokie	Illinois
United States	Novartis Investigator Site	Springfield	Illinois
United States	Novartis Investigator Site	St. Louis	Missouri
United States	Novartis Investigator Site	Tacoma	Washington
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigator Site	Temecula	California
United States	Novartis Investigator Site	Torrance	California
United States	Novartis Investigator Site	Walnut Creek	California
United States	Novartis Investigator Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)	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 albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.	24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)	No
Secondary	Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)	An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.	End of the study (Week 12, Day 84)	No