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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2012

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)

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

Arms, Groups and Cohorts

  • Experimental: Glyco 25
    • BDP/FF (400/24 daily)+ Glyco 25µg daily
  • Experimental: Glyco 50
    • BDP/FF (400/24 daily)+ Glyco 50 µg daily
  • Experimental: Glyco 100
    • BDP/FF (400/24 daily)+ Glyco 100µg daily
  • Active Comparator: BDP/FF 400/24
    • BDP/FF 400/24

Clinical Trial Outcome Measures

Primary Measures

  • Aera under curve FEV1 AUC 0-12h
    • Time Frame: day 1 and 7 of treatment period

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chiesi Farmaceutici S.p.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dave Singh, MD, Principal Investigator, Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University

Citations Reporting on Results

Singh D, Schroder-Babo W, Cohuet G, Muraro A, Bonnet-Gonod F, Petruzzelli S, Hoffmann M, Siergiejko Z; TRIDENT study investigators. The bronchodilator effects of extrafine glycopyrronium added to combination treatment with beclometasone dipropionate plus formoterol in COPD: A randomised crossover study (the TRIDENT study). Respir Med. 2016 May;114:84-90. doi: 10.1016/j.rmed.2016.03.018. Epub 2016 Mar 26.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.