Chronic Obstructive Pulmonary Disease Clinical Trial
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
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigator Site | Genk | |
Belgium | Novartis Investigator Site | Hasselt | |
Belgium | Novartis Investigator Site | Herentals | |
Spain | Novartis Investigator Site | Alicante | |
Spain | Novartis Investigator site | Alzira | |
Spain | Novartis Investigator Site | Madrid | |
Spain | Novartis Investigator site | Mataro | |
United States | Novartis Investigator Site | Charlotte | North Carolina |
United States | Novartis Investigator site | Cincinnati | Ohio |
United States | Novartis Investigator Site | Lafayette | Louisiana |
United States | Novartis Investigator Site | Normal | Illinois |
United States | Novartis Investigator Site | Raleigh | North Carolina |
United States | Novartis Investigator Site | Shawnee Mission | Kansas |
United States | Novartis Investigator Site | Spartanburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Belgium, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | After 14 days | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 5 minutes post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 15 minutes post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 30 minutes post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 1 hour post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 2 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 3 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 4 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 5 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 6 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 8 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 10 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 11 hours 10 minutes post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 11 hours 45 minutes post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 14 hours post-dose at the end of each treatment period (Day 14) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 20 hours 10 minutes post-dose at the end of each treatment period (Day 15) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 20 hours 45 minutes post-dose at the end of each treatment period (Day 15) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 22 hours post-dose at the end of each treatment period (Day 15) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 23 hours 10 minutes post-dose at the end of each treatment period (Day 15) | No |
Secondary | Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15) | FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate. | 23 hours 45 minutes post-dose at the end of each treatment period (Day 15) | No |
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