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

NCT ID: NCT01476813

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glyco 25

BDP/FF (400/24 daily)+ Glyco 25µg daily

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

comparison of different dosages of drug

Glyco 50

BDP/FF (400/24 daily)+ Glyco 50 µg daily

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

comparison of different dosages of drug

Glyco 100

BDP/FF (400/24 daily)+ Glyco 100µg daily

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

comparison of different dosages of drug

BDP/FF 400/24

BDP/FF 400/24

Group Type ACTIVE_COMPARATOR

Comparator

Intervention Type DRUG

comparison of different dosages of drug versus comparator

Interventions

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Glycopyrrolate

comparison of different dosages of drug

Intervention Type DRUG

Glycopyrrolate

comparison of different dosages of drug

Intervention Type DRUG

Glycopyrrolate

comparison of different dosages of drug

Intervention Type DRUG

Comparator

comparison of different dosages of drug versus comparator

Intervention Type DRUG

Other Intervention Names

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Foster+GLyco 25 Foster+GLyco 50 Foster+GLyco 100 Foster

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dave Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University

Locations

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Medicines Evaluation Unit Ltd.

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 27109816 (View on PubMed)

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-003588-31

Study Record on EU Clinical Trials Register including results

https://www.chiesi.com/clinic/CSR_Synopsis_CCD-1106-PR-0066.pdf

CSR Synopsis available in the CHIESI Clinical Study Register

Other Identifiers

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CCD-1106-PR-0066

Identifier Type: -

Identifier Source: org_study_id