CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 739 enrolled
Drug / intervention
Mometasone furoate +2 moredrug
Likely dose
Mometasone furoate 80 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/NCT01555151
NCT01555151Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma

Novartis Pharmaceuticals·interventional·Posted Mar 15, 2012·Updated May 1, 2015

In Brief

A Phase 2 clinical trial evaluating Mometasone furoate, Concept 1, and 1 other intervention for Asthma. Completed, enrolled 739 participants across 165 sites in 17 countries.

Detailed Summary

The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Canada, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russia, Slovakia, Thailand, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2012
Enrollment StartJul 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.3 years ago

Interventions

Mometasone furoatedrug

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Concept 1device

A single dose dry powder inhaler (SDDPI)

Twisthalerdevice

A single dose dry powder inhaler (SDDPI)