Clinical trial NCT00622635: A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
indacaterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)
timeFrame: After 14 days
Secondary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 5 minutes post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 15 minutes post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 30 minutes post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 1 hour post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 2 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 3 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 4 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 5 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 6 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 8 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 10 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 11 hours 10 minutes post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 11 hours 45 minutes post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)
timeFrame: 14 hours post-dose at the end of each treatment period (Day 14)
measure: Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)
timeFrame: 20 hours 10 minutes post-dose at the end of each treatment period (Day 15)
measure: Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
timeFrame: 20 hours 45 minutes post-dose at the end of each treatment period (Day 15)
measure: Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)
timeFrame: 22 hours post-dose at the end of each treatment period (Day 15)
measure: Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)
timeFrame: 23 hours 10 minutes post-dose at the end of each treatment period (Day 15)
measure: Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)
timeFrame: 23 hours 45 minutes post-dose at the end of each treatment period (Day 15)
Other outcomes:
Locations:
city: Normal
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Shawnee Mission
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Lafayette
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Charlotte
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigator site
state: Ohio
city: Spartanburg
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Genk
country: Belgium
facility: Novartis Investigator Site
city: Hasselt
country: Belgium
facility: Novartis Investigator Site
city: Herentals
country: Belgium
facility: Novartis Investigator Site
city: Alicante
country: Spain
facility: Novartis Investigator Site
city: Alzira
country: Spain
facility: Novartis Investigator site
city: Madrid
country: Spain
facility: Novartis Investigator Site
city: Mataro
country: Spain
facility: Novartis Investigator site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: