Status:
COMPLETED
A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.
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 out patients 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 10 pack years (current or previous smokers)
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥30% of the predicted normal value.
- Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%
Exclusion
- 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 for chronic hypoxemia
- Patients who have had a respiratory tract infection within 6 weeks prior to Visit
- 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 Visit 1 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, MDI or perform spirometry measurements
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00615459
Start Date
February 1 2008
End Date
December 1 2008
Last Update
August 17 2011
Active Locations (20)
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1
Novartis Investigative site
Camperdown, Australia
2
Novartis Investigator Site
Gauting, Germany
3
Novartis Investigator Site
Großhansdorf, Germany
4
Novartis Investigator Site
Mainz, Germany