A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: BDP/Formoterol Next DPI; Drug: Foster

• Registration Number: NCT00862394
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Primary Completion: 2009-10
• Study Completion: 2010-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 783

Inclusion Criteria

• Written informed consent
• Outpatients of both sexes, aged > 12 years
• Moderate to severe symptomatic asthma
• Forced expiratory volume in the first second (FEV1) > 40% and < 80% of the predicted normal values
• Reversibility test
• "Partly controlled" asthma (GINA revised 2006)
• Patients free of long-acting beta2-agonists (LABAs) treatment
• Under inhaled corticosteroids (ICS) treatment
• A minimum inspiratory flow ≥ 40 L/min 10.
• Non-smokers or ex smokers
• Asthma Control Questionnaire ACQ score ≥ 1.5

Exclusion Criteria

• Pregnant or nursing (lactating) women
• Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
• Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
• History of near fatal asthma
• Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
• Diagnosis COPD
• 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 (3 months for parenteral depot corticosteroids)
• Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
• Allergy to any component of the study treatments
• Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
• Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
• Patients with abnormal QTc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BDP/Formoterol Next DPI	CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg
2	Foster	CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg
4	Foster	CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg
3	BDP/Formoterol Next DPI	CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg

Primary Outcome Measures

Name	Time	Method
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic	3 month period

Secondary Outcome Measures

Name	Time	Method
Morning and evening asthma clinical symptoms scores	every day
Moderate and severe exacerbations	every month
Sputum	3 month period
Post-dose FEV1 AUC 0-8 h	3 month period
Pre-dose FEV1	every month
FVC and FEF 25-75%	every month
PEF	every day
Rescue medication	every day

Trial Locations

Locations (1)

Oliver Kornmann - National Coordinator in Germany; 🇩🇪 Mainz, Germany