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Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration

NCT01176903 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-10-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Glycopyrrolate

pressurized metered dose inhaler

DRUG

Tiotropium

inhalation powder, hard capsule

DRUG

placebo

pressurized metered dose inhaler

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · Medicines Evaluation Unit Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2011-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

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 NCT01176903 on ClinicalTrials.gov