CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Indacaterol +3 moredrug
Likely dose
Salmeterol 50 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01079130
NCT01079130Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control

Novartis Pharmaceuticals·interventional·Posted Mar 2, 2010·Updated Aug 19, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Salmeterol, and 2 other interventions for Asthma. Completed, enrolled 511 participants across 71 sites.

Detailed Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.3 years ago

Interventions

Indacateroldrug

Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.

Salmeteroldrug

50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.

Placebo to Indacateroldrug

Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.

Placebo to Salmeteroldrug

Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).