Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Information source: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Glycopyrrolate (Drug); Glycopyrrolate (Drug); Glycopyrrolate (Drug); Comparator (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Chiesi Farmaceutici S.p.A. Official(s) and/or principal investigator(s): Dave Singh, MD, Principal Investigator, Affiliation: Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
Summary
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF
in COPD patients.
Clinical Details
Official title: A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Aera under curve FEV1 AUC 0-12h
Detailed description:
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO
EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH
FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTERŪ) IN A METERED DOSE
INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)
- Patients under Double
- Patients under triple therapy (for 1 Mo prior Screening)
Exclusion Criteria:
- Pregnant or lactating women
- Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or
antibiotics, hospitalization
- concommitant diseases impacting feasibility or safety
Locations and Contacts
Medicines Evaluation Unit Ltd., Manchester, United Kingdom
Additional Information
Starting date: March 2012
Last updated: July 26, 2013
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