DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017