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Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate

NCT01476813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2021-10-29

No results posted yet for this study

Summary

dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Glycopyrrolate

comparison of different dosages of drug

DRUG

Glycopyrrolate

comparison of different dosages of drug

DRUG

Glycopyrrolate

comparison of different dosages of drug

DRUG

Comparator

comparison of different dosages of drug versus comparator

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-09-30
Completion
2013-07-31

Countries

  • United Kingdom

Study Locations

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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 NCT01476813 on ClinicalTrials.gov