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

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: CHF 1535 100/6 pMDI 2 months; Drug: BDP DPI 2 months; Drug: CHF 1535 100/6 NEXT DPI® 2 months

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345916

2010-023281-47 (EudraCT Number)

CCD-1009-PR-0050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 932 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

932 participants in 3 patient groups

CHF 1535 100/6 NEXT Dry Powder Inhaler®

Experimental group

Description:

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

Treatment:

Drug: CHF 1535 100/6 NEXT DPI® 2 months

CHF1535 100/6 pMDI

Active Comparator group

Description:

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

Treatment:

Drug: CHF 1535 100/6 pMDI 2 months

beclomethasone dipropionate DPI

Active Comparator group

Description:

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

Treatment:

Drug: BDP DPI 2 months