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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Salmeterol Xinafoate

Criteria

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