Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615030
• Other study ID #: CQAB149B2305
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2008
• Last updated: July 22, 2011
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
• Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
• Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
• Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI

Locations

Country	Name	City	State
France	Novartis Investigative Site	Beuvry
France	Novartis Investigative Site	Nantes
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Spain	Novartis Investigative Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo	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.	After 14 days of treatment	No
Secondary	Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons	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.	After 14 days of dosing	No