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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate

Criteria

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