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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089127
• Other study ID #: CQAB149B2356
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2010
• Last updated: July 22, 2011
• Start date: March 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 study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• 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:

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.

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Bayside	New York
United States	Novartis Investigator Site	Bellevue	Nebraska
United States	Novartis Investigator Site	Cadiz	Ohio
United States	Novartis Investigator Site	Canton	Ohio
United States	Novartis Investigative site	Charleston	South Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cherry Hill	New Jersey
United States	Novartis Investigator Site	Clearwater	Florida
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigator Site	Columbus	Ohio
United States	Novartis Investigator Site	Cookeville	Tennessee
United States	Novartis Investigator Site	Defuniak Springs	Florida
United States	Novartis Investigator Site	Dickinson	Texas
United States	Novartis Investigative Site	Easley	South Carolina
United States	Novartis Investigator Site	Edina	Minnesota
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigator Site	Florence	Alabama
United States	Novartis Investigator Site	Florence	Kentucky
United States	Novartis Investigative Site	Fredericksburg	Virginia
United States	Novartis Investigator Site	Fridley	Minnesota
United States	Novartis Investigator Site	Ft. Worth	Texas
United States	Novartis Investigator Site	Fullerton	California
United States	Novartis Investigative Site	Glastonbury	Connecticut
United States	Novartis Investigative Site	Great Neck	New York
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigator Site	Henderson	Nevada
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigator Site	Jasper	Alabama
United States	Novartis Investigative Site	Lake Success	New York
United States	Novartis Investigative Site	Larchmont	New York
United States	Novartis Investigator Site	Las Vegas	Nevada
United States	Novartis Investigator Site	Las Vegas	Nevada
United States	Novartis Investigator Site	Lebanon	New Hampshire
United States	Novartis Investigator Site	Lincoln	Nebraska
United States	Novartis Investigator Site	Madisonville	Kentucky
United States	Novartis Investigator Site	McKinney	Texas
United States	Novartis Investigator Site	Medford	Oregon
United States	Novartis Investigator Site	Miami	Florida
United States	Novartis Investigator Site	Minneapolis	Minnesota
United States	Novartis Investigative site	Newport News	Virginia
United States	Novartis Investigator Site	O'Fallon	Illinois
United States	Novartis Investigator Site	Omaha	Nebraska
United States	Novartis Investigator Site	Opelousas	Louisiana
United States	Novartis Investigator Site	Ozark	Missouri
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigator Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenixville	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Rancho Mirage	California
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigator Site	Riverside	California
United States	Novartis Investigator Site	Salt Lake City	Utah
United States	Novartis Investigator Site	San Diego	California
United States	Novartis Investigator Site	Searcy	Arkansas
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	Spartanburg	South Carolina
United States	Novartis Investigator Site	St. Louis	Missouri
United States	Novartis Investigative Site	Stamford	Connecticut
United States	Novartis Investigator Site	Stockton	California
United States	Novartis Investigator Site	Tacoma	Washington
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigator Site	Tampa	Florida
United States	Novartis Investigator Site	Temecula	California
United States	Novartis Investigator Site	Toledo	Ohio
United States	Novartis Investigative Site	Union	South Carolina
United States	Novartis Investigator Site	Walnut Creek	California
United States	Novartis Investigator Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

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 2 + 1 Day, Day 15)	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.	24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2	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.	24 hours post-dose on Day 2	No