Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,059
In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Time frame: after 12 weeks of treatment
The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period
A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.
Time frame: up to 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Medicine Associates PC
Homewood, Alabama, United States
Jasper Summit Research
Jasper, Alabama, United States
Pulmonary Associate of Mobile, PC
Mobile, Alabama, United States
Pulmonary Associates, PA
Glendale, Arizona, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
Novartis Investigative Center
Scottsdale, Arizona, United States
Arizona Pulmonary Specialists, LTD
Scottsdale, Arizona, United States
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, United States
...and 334 more locations