Clinical trial NCT01345916: Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients
Official title: 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.
timeFrame: at 8 weeks
Secondary outcomes:
measure: Pre-dose morning FEV1 (Forced Expiratory Volume in one second);
timeFrame: at 2, 4, 6 and 8 weeks of treatment
measure: Pre-dose morning FVC (Force Vital Capacity) ;
timeFrame: at 2, 4, 6 and 8 weeks of treatment
measure: ACQ (Asthma Control Questionnaire) score ;
timeFrame: at eight weeks
measure: pre-dose evening PEF ;
timeFrame: at 2, 4, 6 and 8 weeks of treatment
measure: daily PEF variability ;
timeFrame: at 2, 4, 6 and 8 weeks of treatment
measure: use of rescue medication ;
timeFrame: at 2, 4, 6 and 8 weeks of treatment
measure: percentage of rescue use-free days
timeFrame: at 2, 4, 6 and 8 weeks of treatment
measure: pre-dose morning PEF ;
timeFrame: at 2, 4, 6 and 8 weeks of treatment
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: GSPZOZ Uniwersytecki Szpital Kliniczny
Study officials:
affiliation: Gemeinschaftspraxis Reinfeld - Raiffeisenpassage 15 - D-23858 Reinfeld - Germany
name: Frank KANNIESS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanniess F, Scuri M, Vezzoli S, Francisco C, Petruzzelli S. Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler((R))) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial. Pulm Pharmacol Ther. 2015 Feb;30:121-7. doi: 10.1016/j.pupt.2014.07.006. Epub 2014 Aug 1.