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

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620022
• Other study ID #: CQAB149B2311
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2008
• Last updated: July 22, 2011
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyItaly: The Italian Medicines AgencySpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 300 µg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
• Placebo
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Locations

Country	Name	City	State
Belgium	Novartis Investigator Site	Bruxelles
Belgium	Novartis Investigator Site	Gembloux
Belgium	Novartis Investigator Site	Jette
Belgium	Novartis Investigator Site	Liege
Canada	Novartis Investigator Site	Edmonton
Canada	Novartis Investigator Site	Kingston
Denmark	Novartis Investigator Site	Aarhus
Denmark	Novartis Investigative Site	Hellerup
Denmark	Novartis Investigator Site	Hvidovre
Denmark	Novartis Investigative site	Odense
Italy	Novartis Investigator Site	Genova
Italy	Novartis Investigator Site	Pisa
Italy	Novartis Investigator Site	Verona
Spain	Novartis Investigator Site	Alicante
Spain	Novartis Investigator Site	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative site	Seville
Spain	Novartis Investigator Site	Zaragoza
United States	Novartis Investigator Site	Lebanon	New Hampshire
United States	Novartis Investigator Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period	At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.	End of each 3 week treatment period (last day of Weeks 3 and 9)	No
Secondary	Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose	At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.	End of each 3 week treatment period (last day of Weeks 3 and 9)	No