The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00620022

Run by

Novartis

People needed

90

Starts

2008-04-01

Expected to finish

2009-01-01

Last updated by the study team

2011-08-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Hellerup, Denmark
• Novartis Investigator Site — Hvidovre, Denmark
• Novartis Investigative site — Odense, Denmark
• Novartis Investigator Site — Genova, Italy
• Novartis Investigator Site — Pisa, Italy
• Novartis Investigator Site — Verona, Italy
• Novartis Investigator Site — Alicante, Spain
• Novartis Investigator Site — Barcelona, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative site — Seville, Spain
• Novartis Investigator Site — Zaragoza, Spain
• Novartis Investigator Site — Torrance, California, United States
• Novartis Investigator Site — Lebanon, New Hampshire, United States
• Novartis Investigator Site — Brussels, Belgium
• Novartis Investigator Site — Gembloux, Belgium
• Novartis Investigator Site — Jette, Belgium
• Novartis Investigator Site — Liège, Belgium
• Novartis Investigator Site — Edmonton, Canada
• Novartis Investigator Site — Kingston, Canada
• Novartis Investigator Site — Aarhus, Denmark

Full record on ClinicalTrials.gov

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