Clinical trial NCT00620022: The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: indacaterol
chronic obstructive pulmonary disease
exercise endurance
moderate to severe chronic obstructive pulmonary disease
COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
timeFrame: End of each 3 week treatment period (last day of Weeks 3 and 9)
Secondary outcomes:
measure: Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
timeFrame: End of each 3 week treatment period (last day of Weeks 3 and 9)
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Novartis Investigator Site
state: California
city: Lebanon
country: United States
facility: Novartis Investigator Site
state: New Hampshire
city: Bruxelles
country: Belgium
facility: Novartis Investigator Site
city: Gembloux
country: Belgium
facility: Novartis Investigator Site
city: Jette
country: Belgium
facility: Novartis Investigator Site
city: Liege
country: Belgium
facility: Novartis Investigator Site
city: Edmonton
country: Canada
facility: Novartis Investigator Site
city: Kingston
country: Canada
facility: Novartis Investigator Site
city: Aarhus
country: Denmark
facility: Novartis Investigator Site
city: Hellerup
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigator Site
city: Odense
country: Denmark
facility: Novartis Investigative site
city: Genova
country: Italy
facility: Novartis Investigator Site
city: Pisa
country: Italy
facility: Novartis Investigator Site
city: Verona
country: Italy
facility: Novartis Investigator Site
city: Alicante
country: Spain
facility: Novartis Investigator Site
city: Barcelona
country: Spain
facility: Novartis Investigator Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Seville
country: Spain
facility: Novartis Investigative site
city: Zaragoza
country: Spain
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma
role: STUDY_CHAIR
References:
citation: O'Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, Kramer B; INABLE 1 study group. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med. 2011 Jul;105(7):1030-6. doi: 10.1016/j.rmed.2011.03.014. Epub 2011 Apr 16.