Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma

March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.

A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma

Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma

Study Type

Interventional

Enrollment (Anticipated)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate or severe asthma partly controlled with ICS or ICS/LABA
  • FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value

Exclusion Criteria:

  • Diagnosis of COPD
  • History or current evidence of significant cardiovascular disease
  • Uncontrolled concomitant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CHF 5188 pMDI
Drug: CHF 5188 pMDI
CHF 5188: fixed combination budesonide/carmoterol
ACTIVE_COMPARATOR: Budesonide extrafine pMDI
Drug: Budesonide extrafine pMDI
Budesonide extrafine pMDI
ACTIVE_COMPARATOR: Seretide(r) Evohaler(r)
Drug: Seretide(r) Evohaler(r)
Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Trough FEV1 (mean 23h-24h FEV1)
Time Frame: after day 28 dose
after day 28 dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)
Time Frame: after day 1 dose
after day 1 dose
Trough FVC (mean 23-24h)
Time Frame: after day 28 dose
after day 28 dose
Peak FEV1 and FVC
Time Frame: on day 1 and day 28
on day 1 and day 28
FEV1 AUC0-24
Time Frame: after day 1 and day 28
after day 1 and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Dave Singh, MD, The Medicines Evaluation Unit Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (ESTIMATE)

February 18, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-0909-PR-0020
  • 2009-013759-32 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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