Status:
COMPLETED
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Pulmonary Disease, Chronic Obstructive
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2...
Eligibility Criteria
Inclusion
- 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 COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value.
- Post-bronchodilator FEV1/FVC \< 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)
Exclusion
- 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)
- Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
- Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
- Patients with a history of asthma (with further criteria)
- Patients with Type I or uncontrolled Type II diabetes
- Patients with contraindications for tiotropium
- 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
- Patients with a history of long QT syndrome or whose QTc interval is prolonged
- Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
- Patients who have had treatment with the investigational drug (with further criteria)
- Patients who have had live attenuated vaccinations within 30 days prior to visit 1, 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
2059 Patients enrolled
Trial Details
Trial ID
NCT00463567
Start Date
April 1 2007
End Date
August 1 2008
Last Update
August 18 2011
Active Locations (344)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
3
Pulmonary Medicine Associates PC
Homewood, Alabama, United States, 35209
4
Jasper Summit Research
Jasper, Alabama, United States, 35501