Trial | NCT01345916  Report issue

Title

Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients
A Phase 3,8-week Clinical Trial to Test the Efficacy of CHF1535 Via NEXT DPI® Versus Same Dose of CHF1535 pMDI and Beclomethasone DPI 100µg on PEF in Adult Asthmatic Patients After 1 Month of Treatment With FOSTER®

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    beclomethasone ...

  • Study Participants

    932
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.
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.
Study Started
Mar 31
2011
Primary Completion
Aug 31
2011
Study Completion
Aug 31
2011
Last Update
Mar 30
2017

Drug CHF 1535 100/6 NEXT DPI® 2 months

CHF 1535 100/6 NEXT DPI® 2 months

Drug CHF 1535 100/6 pMDI 2 months

CHF 1535 100/6 pMDI 2 months

  • Other names: Foster®

Drug BDP DPI 2 months

BDP DPI 2 months

  • Other names: Clenil® Pulvinal®

CHF 1535 100/6 NEXT Dry Powder Inhaler® Experimental

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

CHF1535 100/6 pMDI Active Comparator

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

beclomethasone dipropionate DPI Active Comparator

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

History of near fatal asthma.
COPD patients
Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
Lower respiratory tract infection within 1 month prior Visit1 (V1).
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 before V1
Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
Significant medical history of and/or treatments
Active cancer or a history of cancer .
No Results Posted