Status:
COMPLETED
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe 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 outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the 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/forced vital capacity (FVC) \< 70%.
Exclusion
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
- Patients requiring oxygen therapy or who experience oxygen desaturation to \< 80% during cycle exercise on room air.
- Patients with a Wmax value \< 20 W (as determined by the incremental cycle endurance test) at screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with contra-indications of cardiopulmonary exercise testing.
- Patients with concomitant pulmonary disease.
- Patients with a history (up to and including the screening visit) 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 the collection of informed consent visit (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, metered dose inhaler (MDI), or perform spirometry measurements.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00620022
Start Date
April 1 2008
End Date
January 1 2009
Last Update
August 17 2011
Active Locations (20)
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1
Novartis Investigator Site
Torrance, California, United States
2
Novartis Investigator Site
Lebanon, New Hampshire, United States
3
Novartis Investigator Site
Brussels, Belgium
4
Novartis Investigator Site
Gembloux, Belgium