CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
75 µg indacaterol maleate (LB) +4 moredrug
Likely dose
75 µg indacaterol maleate (LB)from 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/NCT01484197
NCT01484197Phase 2Completed
CompareCT.gov

A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma

Novartis Pharmaceuticals·interventional·Posted Dec 2, 2011·Updated Apr 1, 2015

In Brief

A Phase 2 clinical trial evaluating 75 µg indacaterol maleate (LB), 75 µg indacaterol maleate (PoS), and 3 other interventions for Asthma. Completed, enrolled 36 participants across 2 sites in 2 countries.

Detailed Summary

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.6 years ago

Interventions

75 µg indacaterol maleate (LB)drug

75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

75 µg indacaterol maleate (PoS)drug

75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

37.5 µg indacaterol maleate (PoS)drug

37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

placebo to indacaterol (LB)drug

Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

placebo to indacaterol (PoS)drug

Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.