CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 152 enrolled
Drug / intervention
NVA237 +4 moredrug
Likely dose
NVA237 44 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/NCT01922271
NCT01922271Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Multicenter, 2-period Single-dose Cross-over Study to Assess the Early Bronchodilation of Glycopyrronium Bromide (44 μg o.d.) Compared to Tiotropium (18 µg. o.d.) in Patients With Moderate to Severe COPD (FAST Study)

Novartis Pharmaceuticals·interventional·Posted Aug 14, 2013·Updated Jan 1, 2015

In Brief

A Phase 4 clinical trial evaluating NVA237, Tiotropium, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 152 participants across 14 sites.

Detailed Summary

The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 14, 2013
Enrollment StartAug 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.9 years ago

Interventions

NVA237drug

NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)

Tiotropiumdrug

Tiotropium 18 μg once daily delivered via HandiHaler® device.

Placebo to NVA237drug

Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).

Placebo to tiotropiumdrug

Placebo to tiotropium once daily delivered via HandiHaler® device

Salbutamoldrug

Used as resuce medication