A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma

NCT00545272 Phase 2 COMPLETED Results posted

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	COMPLETED
Enrolment	392
Start date	2007-10
Completion	2008-04

Conditions

• Asthma

Interventions

• indacaterol
• formoterol
• placebo to indacaterol
• placebo to formoterol
• short acting β2-agonist

Primary outcomes

• The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) — Baseline (prior to first dose) and Day 15 (24 hours after last dose)
  FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.

Countries

Belgium, Czechia, Germany, Hungary, Israel, Poland, Russia, South Africa, Spain, United Kingdom