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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862394
• Other study ID #: CCD-0705-PR-0027
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2009
• Last updated: April 12, 2018
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2018
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 783
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• BDP/Formoterol Next DPI
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
• Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
• BDP/Formoterol Next DPI
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
• Foster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)

Locations

Country	Name	City	State
Germany	Oliver Kornmann - National Coordinator in Germany	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre-dose FEV1		every month
Secondary	Post-dose FEV1 AUC 0-8 h		3 month period
Secondary	FVC and FEF 25-75%		every month
Secondary	PEF		every day
Secondary	Morning and evening asthma clinical symptoms scores		every day
Secondary	Moderate and severe exacerbations		every month
Secondary	Rescue medication		every day
Secondary	Sputum		3 month period

External Links

•   Study Record on EU Clinical Trials Register including results