Status:
COMPLETED
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time pe...
Eligibility Criteria
Inclusion
- 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 forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%
Exclusion
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia
- 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
- 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 (Bazett's) measured at screening or randomization is prolonged
- Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
- Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00622635
Start Date
January 1 2008
End Date
July 1 2008
Last Update
August 18 2011
Active Locations (14)
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1
Novartis Investigator Site
Normal, Illinois, United States
2
Novartis Investigator Site
Shawnee Mission, Kansas, United States
3
Novartis Investigator Site
Lafayette, Louisiana, United States
4
Novartis Investigator Site
Charlotte, North Carolina, United States