CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 934 enrolled
Drug / intervention
QVA149 +5 moredrug
Likely dose
QVA149 50µgfrom 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/NCT01574651
NCT01574651Phase 3Completed
CompareCT.gov

A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Using Tiotropium Plus Formoterol as Control

Novartis Pharmaceuticals·interventional·Posted Apr 10, 2012·Updated May 22, 2014

In Brief

A Phase 3 clinical trial evaluating QVA149, Placebo to tiotropium, and 4 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 934 participants across 144 sites.

Detailed Summary

This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2012
Enrollment StartMay 1, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.2 years ago

Interventions

QVA149drug

QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler

Placebo to tiotropiumdrug

Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules

Placebo to formoteroldrug

Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.

Tiotropiumdrug

Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.

Formoteroldrug

Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.

Placebo to QVA149drug

Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules