CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
SUN-101 via eFlow nebulizer +4 moredrug
Likely dose
SUN-101 via eFlow nebulizer 50 mcgfrom 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/NCT02512302
NCT02512302Phase 1Completed
CompareCT.gov

A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Sunovion Respiratory Development Inc.·interventional·Posted Jul 30, 2015·Updated Oct 25, 2018

In Brief

A Phase 1 clinical trial evaluating SUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal, and 3 other interventions for COPD. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 30, 2015
Enrollment StartOct 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.9 years ago

Interventions

SUN-101 via eFlow nebulizerdrug

50 mcg glycopyrrolate via Electronic Nebulizer

SUN-101 via eFlow nebulizer with activated charcoaldrug

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

Seebri® Breezhaler®drug

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

Seebri® Breezhaler® with activated charcoaldrug

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

Glycopyrrolate Injectiondrug

50 mcg glycopyrrolate via IV