A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

April 12, 2018 updated by: Chiesi Farmaceutici S.p.A.

A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

783

Phase

  • Phase 3

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

  • Germany
      • Mainz, Germany, 55131
        • Oliver Kornmann - National Coordinator in Germany

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

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Outpatients of both sexes, aged > 12 years
  • Moderate to severe symptomatic asthma
  • Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
  • Reversibility test
  • "Partly controlled" asthma (GINA revised 2006)
  • Patients free of long-acting beta2-agonists (LABAs) treatment
  • Under inhaled corticosteroids (ICS) treatment
  • A minimum inspiratory flow ≥ 40 L/min 10.
  • Non-smokers or ex smokers
  • Asthma Control Questionnaire ACQ score ≥ 1.5

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
  • Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
  • History of near fatal asthma
  • Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
  • Diagnosis COPD
  • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
  • Diagnosis of restrictive lung disease
  • Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
  • Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
  • Allergy to any component of the study treatments
  • Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
  • Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
  • Patients with abnormal QTc

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg
Drug: BDP/Formoterol Next DPI
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
Drug: BDP/Formoterol Next DPI
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
ACTIVE_COMPARATOR: 2
CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg
Drug: Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
Drug: Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
EXPERIMENTAL: 3
CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg
Drug: BDP/Formoterol Next DPI
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
Drug: BDP/Formoterol Next DPI
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
ACTIVE_COMPARATOR: 4
CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg
Drug: Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
Drug: Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
Time Frame: 3 month period
3 month period

Secondary Outcome Measures

Outcome Measure
Time Frame
Pre-dose FEV1
Time Frame: every month
every month
Post-dose FEV1 AUC 0-8 h
Time Frame: 3 month period
3 month period
FVC and FEF 25-75%
Time Frame: every month
every month
PEF
Time Frame: every day
every day
Morning and evening asthma clinical symptoms scores
Time Frame: every day
every day
Moderate and severe exacerbations
Time Frame: every month
every month
Rescue medication
Time Frame: every day
every day
Sputum
Time Frame: 3 month period
3 month period

Collaborators and Investigators

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

Sponsor

Chiesi Farmaceutici S.p.A.

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

February 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (ESTIMATE)

March 16, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-0705-PR-0027

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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