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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

Page last updated: August 23, 2015

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