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

NCT00620022 | Completed Phase 3 Results

• 1 other identifier: CQAB149B2311
• Study Type: interventional
• Target: 90
• Locations: 6 countries
• Sites: 20

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

indacaterol; chronic obstructive pulmonary disease; exercise endurance; moderate to severe chronic obstructive pulmonary disease; COPD

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose

  End of each 3 week treatment period (last day of Weeks 3 and 9)

Study Arms (2)

Indacaterol 300 μg followed by placebo

EXPERIMENTAL

Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 300 μg; Drug: Placebo

Placebo followed by indacaterol 300 μg

EXPERIMENTAL

Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 300 μg; Drug: Placebo

Interventions

Indacaterol 300 μg DRUG

Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Indacaterol 300 μg followed by placebo; Placebo followed by indacaterol 300 μg

Placebo DRUG

Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Indacaterol 300 μg followed by placebo; Placebo followed by indacaterol 300 μg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (20)

Novartis Investigator Site

Torrance, California, United States

Location

Novartis Investigator Site

Lebanon, New Hampshire, United States

Location

Novartis Investigator Site

Brussels, Belgium

Location

Novartis Investigator Site

Gembloux, Belgium

Location

Novartis Investigator Site

Jette, Belgium

Location

Novartis Investigator Site

Liège, Belgium

Location

Novartis Investigator Site

Edmonton, Canada

Location

Novartis Investigator Site

Kingston, Canada

Location

Novartis Investigator Site

Aarhus, Denmark

Location

Novartis Investigative Site

Hellerup, Denmark

Location

Novartis Investigator Site

Hvidovre, Denmark

Location

Novartis Investigative site

Odense, Denmark

Location

Novartis Investigator Site

Genova, Italy

Location

Novartis Investigator Site

Pisa, Italy

Location

Novartis Investigator Site

Verona, Italy

Location

Novartis Investigator Site

Alicante, Spain

Location

Novartis Investigator Site

Barcelona, Spain

Location

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigative site

Seville, Spain

Location

Novartis Investigator Site

Zaragoza, Spain

Location

Related Publications (1)

• 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.

  PMID: 21498063 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharma

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 17, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-07

Locations

ES (5); US (2); DK (4); BE (4); CA (2); IT (3)