Clinical trial NCT00862394: 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
Official title: A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 783
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
timeFrame: 3 month period
Secondary outcomes:
measure: Pre-dose FEV1
timeFrame: every month
measure: Post-dose FEV1 AUC 0-8 h
timeFrame: 3 month period
measure: FVC and FEF 25-75%
timeFrame: every month
measure: PEF
timeFrame: every day
measure: Morning and evening asthma clinical symptoms scores
timeFrame: every day
measure: Moderate and severe exacerbations
timeFrame: every month
measure: Rescue medication
timeFrame: every day
measure: Sputum
timeFrame: 3 month period
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Oliver Kornmann - National Coordinator in Germany
Study officials:
References: