Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

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: NCT01068600
• Other study ID #: CQAB149B2355
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2010
• Last updated: July 22, 2011
• Start date: January 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: 318
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of 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 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 for 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 may apply

Study Design

Allocation: Randomized, 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
Once daily via single-dose dry powder inhaler (SDDPI)
• Placebo to indacaterol
Once daily via SDDPI

Locations

Country	Name	City	State
United States	Novartis Investigator Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigator Site	Arlington	Texas
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigator Site	Baton Rouge	Louisiana
United States	Novartis Investigative 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	Cincinnati	Ohio
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Cumberland	Rhode Island
United States	Novartis Investigator Site	Dickinson	Texas
United States	Novartis Investigative Site	Easley	South Carolina
United States	Novartis Investigator Site	El Paso	Texas
United States	Novartis Investigator Site	Eugene	Oregon
United States	Novartis Investigator Site	Fullerton	California
United States	Novartis Investigator Site	Glendale	Arizona
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	Iowa City	Iowa
United States	Novartis Investigative Site	Jasper	Alabama
United States	Novartis Investigator Site	Las Vegas	Nevada
United States	Novartis Investigator Site	Lincoln	Nebraska
United States	Novartis Investigator Site	Los Angeles	California
United States	Novartis Investigator Site	Los Angeles	California
United States	Novartis Investigative Site	Madisonville	Kentucky
United States	Novartis Investigator Site	Marion	Ohio
United States	Novartis Investigator Site	McKinney	Texas
United States	Novartis Investigator Site	Medford	Oregon
United States	Novartis Investigative site	Miami	Florida
United States	Novartis Investigator Site	Normal	Illinois
United States	Novartis Investigative Site	North Charleston	South Carolina
United States	Novartis Investigator Site	Omaha	Nebraska
United States	Novartis Investigator Site	Omaha	Nebraska
United States	Novartis Investigator Site	Opelousas	Louisiana
United States	Novartis Investigative Site	Pawtucket	Rhode Island
United States	Novartis Investigator Site	Phoenix	Arizona
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigator Site	Riverside	California
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	South Burlington	Vermont
United States	Novartis Investigative Site	Spartanburg	South Carolina
United States	Novartis Investigator Site	St. Charles	Missouri
United States	Novartis Investigator Site	St. Louis	Missouri
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Union	South Carolina
United States	Novartis Investigative Site	Winter Park	Florida

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) After 12 Weeks of Treatment	Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.	after 12 weeks	No
Secondary	Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment	TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.	after 12 weeks	No