A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Indacaterol 300 μg (Drug); Placebo to indacaterol (Drug); Salmeterol 50 μg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This study was conducted to provide detailed information on the efficacy of indacaterol in
terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over
a 24 hour time period.
Clinical Details
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, 3-period, 14-day Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol (300 µg Once Daily [od]) in Patients With Moderate-to-severe COPD, Using Open-label Salmeterol (50 µg Twice Daily [Bis in Die, Bid]) as Active Control
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)
Secondary outcome: Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14) Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15) Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15) Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15) Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15) Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Guidelines, 2006) and:
1. Smoking history of at least 20 pack-years
2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
of the predicted normal value
3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Exclusion Criteria:
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to
screening or during the run-in period
- Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- Patients with concomitant pulmonary disease
- Patients with a history 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 screening 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 or perform spirometry
measurements
Other protocol-defined inclusion/exclusion criteria applied to the study.
Locations and Contacts
Novartis Investigator Site, Genk, Belgium
Novartis Investigator Site, Hasselt, Belgium
Novartis Investigator Site, Herentals, Belgium
Novartis Investigator Site, Alicante, Spain
Novartis Investigator site, Alzira, Spain
Novartis Investigator Site, Madrid, Spain
Novartis Investigator site, Mataro, Spain
Novartis Investigator Site, Normal, Illinois, United States
Novartis Investigator Site, Shawnee Mission, Kansas, United States
Novartis Investigator Site, Lafayette, Louisiana, United States
Novartis Investigator Site, Charlotte, North Carolina, United States
Novartis Investigator Site, Raleigh, North Carolina, United States
Novartis Investigator site, Cincinnati, Ohio, United States
Novartis Investigator Site, Spartanburg, South Carolina, United States
Additional Information
Starting date: January 2008
Last updated: July 22, 2011
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