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

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: BDP/Formoterol Next DPI; Drug: Foster

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862394

CCD-0705-PR-0027

Details and patient eligibility

About

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

Enrollment: 783 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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783 participants in 4 patient groups

1

Experimental group

Description:

CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg

Treatment:

Drug: BDP/Formoterol Next DPI

Drug: BDP/Formoterol Next DPI

2

Active Comparator group

Description:

CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg

Treatment:

Drug: Foster

Drug: Foster

3

Experimental group

Description:

CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg

Treatment:

Drug: BDP/Formoterol Next DPI

Drug: BDP/Formoterol Next DPI

4

Active Comparator group

Description:

CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg

Treatment:

Drug: Foster

Drug: Foster