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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01476813
First received: November 18, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Glycopyrrolate
Drug: Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Aera under curve FEV1 AUC 0-12h [ Time Frame: day 1 and 7 of treatment period ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glyco 25
BDP/FF (400/24 daily)+ Glyco 25µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Name: Foster+GLyco 25
Experimental: Glyco 50
BDP/FF (400/24 daily)+ Glyco 50 µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Name: Foster+GLyco 50
Experimental: Glyco 100
BDP/FF (400/24 daily)+ Glyco 100µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Name: Foster+GLyco 100
Active Comparator: BDP/FF 400/24
BDP/FF 400/24
Drug: Comparator
comparison of different dosages of drug versus comparator
Other Name: Foster

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 (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476813

Locations
United Kingdom
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Dave Singh, MD Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01476813     History of Changes
Other Study ID Numbers: CCD-1106-PR-0066
Study First Received: November 18, 2011
Last Updated: July 26, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Glycopyrrolate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014