Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

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

PHASE3

Total Enrollment

932 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

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Detailed Description

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The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CHF 1535 100/6 NEXT Dry Powder Inhaler®

CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg)

Group Type EXPERIMENTAL

CHF 1535 100/6 NEXT DPI® 2 months

Intervention Type DRUG

CHF 1535 100/6 NEXT DPI® 2 months

CHF1535 100/6 pMDI

CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg)

Group Type ACTIVE_COMPARATOR

CHF 1535 100/6 pMDI 2 months

Intervention Type DRUG

CHF 1535 100/6 pMDI 2 months

beclomethasone dipropionate DPI

beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg)

Group Type ACTIVE_COMPARATOR

BDP DPI 2 months

Intervention Type DRUG

BDP DPI 2 months

Interventions

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CHF 1535 100/6 NEXT DPI® 2 months

Intervention Type DRUG

CHF 1535 100/6 pMDI 2 months

Intervention Type DRUG

BDP DPI 2 months

Intervention Type DRUG

Other Intervention Names

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Foster® Clenil® Pulvinal®

Eligibility Criteria

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Inclusion Criteria

1. Male and female adults (≥18 years old).
2. Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
3. FEV1 \> 80% of the predicted values .
4. Asthma Control Questionnaire score \< 1.25.
5. Asthmatic patients
6. Non- or ex-smokers

Exclusion Criteria

1. History of near fatal asthma.
2. COPD patients
3. Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
4. Lower respiratory tract infection within 1 month prior Visit1 (V1).
5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
6. Diagnosis of restrictive lung disease.
7. Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1
8. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
9. Significant medical history of and/or treatments
10. Active cancer or a history of cancer .

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No