Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

Study identifier:PT001101-00

ClinicalTrials.gov identifier:NCT02433834

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Chronic-Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of PT001 Relative to Placebo Metered Dose Inhaler and Open-Label Serevent® Diskus® in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

No

Study drug

Glycopyrronium MDI, Glycopyrronium MDI, Glycopyrronium MDI, Glycopyrronium MDI, Glycopyrronium MDI, Serevent Diskus 50 μg, Placebo

Sex

All

Actual enrollment

248

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 27 May 2015
Primary Completion Date: 26 Mar 2016
Study Completion Date: 26 Mar 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2018 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria