CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Abediterol 0.156 μg +5 moredrug
Likely dose
Abediterol 0.156 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/NCT02777827
NCT02777827Phase 1Completed

A Randomised, Double-Blinded, Double-Dummy, Placebo-Controlled, MultiCentre-, Six-Way, Crossover Study to Assess the Pharmacodynamics, Pharmacokinetics, and Safety of Abediterol Single Dose, Given by Dry Powder Inhaler (DPI) or Pressurised Metered-Dose Inhaler (pMDI), in Patients With Asthma on Inhaled Corticosteroids.

AstraZeneca·interventional·Posted May 19, 2016·Updated Jan 24, 2019

In Brief

A Phase 1 clinical trial evaluating Abediterol 0.156 μg, Abediterol 2.5 μg, and 2 other interventions for Asthma. Completed, enrolled 30 participants across 4 sites.

Detailed Summary

The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is a potential for once daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel anti-inflammatory agent. The aim of the clinical studies is to enable further investigations in participants with asthma and COPD to evaluate and develop abediterol as an effective long acting bronchodilator with an acceptable safety profile compared to other inhaled bronchodilators on the market, for the treatment of asthma and COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 19, 2016
Enrollment StartJun 21, 2016
Primary CompletionNov 29, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.1 years ago

Interventions

Abediterol 0.156 μgdrug

Dry powder for inhalation

Abediterol 2.5 μgdrug

Dry powder for inhalation

Abediterol 0.05 μgdrug

Pressurised metered-dose inhaler

Abediterol 0.156 μgdrug

Pressurised metered-dose inhaler

Abediterol 2.5 μgdrug

Pressurised metered-dose inhaler

Placeboother

Pressurised metered-dose inhaler and dry powder for inhalation.