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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

NCT02433834 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2017-07-02

Study results available
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Summary

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

Conditions

Interventions

DRUG

Glycopyrronium MDI

GP MDI

DRUG

Serevent Diskus 50 μg

DRUG

Placebo

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Shahid Siddiqui · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-27
Primary Completion
2016-03-26
Completion
2016-03-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433834 on ClinicalTrials.gov