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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: CHF 1535 100/6 pMDI 2 months; Drug: CHF 1535 100/6 NEXT DPI® 2 months; Drug: BDP DPI 2 months

• Registration Number: NCT01345916
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 932

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF1535 100/6 pMDI	CHF 1535 100/6 pMDI 2 months	CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg)
CHF 1535 100/6 NEXT Dry Powder Inhaler®	CHF 1535 100/6 NEXT DPI® 2 months	CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg)
beclomethasone dipropionate DPI	BDP DPI 2 months	beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg)

Primary Outcome Measures

Name	Time	Method
Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.	at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Pre-dose morning FEV1 (Forced Expiratory Volume in one second);	at 2, 4, 6 and 8 weeks of treatment
Pre-dose morning FVC (Force Vital Capacity) ;	at 2, 4, 6 and 8 weeks of treatment
ACQ (Asthma Control Questionnaire) score ;	at eight weeks
pre-dose evening PEF ;	at 2, 4, 6 and 8 weeks of treatment
daily PEF variability ;	at 2, 4, 6 and 8 weeks of treatment
use of rescue medication ;	at 2, 4, 6 and 8 weeks of treatment
percentage of rescue use-free days	at 2, 4, 6 and 8 weeks of treatment
pre-dose morning PEF ;	at 2, 4, 6 and 8 weeks of treatment

Trial Locations

Locations (1)

GSPZOZ Uniwersytecki Szpital Kliniczny; 🇵🇱 Łódź, Poland