A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg; Drug: Placebo; Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg

• Registration Number: NCT02148120
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-28
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient's written informed consent obtained prior to any study-related procedures.
• Male or female aged between 18 and 65 years inclusive;
• Evidence for "partially controlled" or "uncontrolled" asthma;
• Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
• FEV1 between 60% and 85% of the predicted normal values;
• A documented positive response to the reversibility test;
• Non-smokers or ex-smokers;
• A cooperative attitude and ability to be trained in the proper use of a DPI.

Exclusion Criteria

• Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
• Significant seasonal variation in asthma occurring or expected to occur during study participation;
• History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
• Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
• Diagnosis of Chronic Obstructive Pulmonary Disease;
• 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 8 weeks;
• Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
• Allergy, sensitivity or intolerance to study drugs or excipients;
• Patients who received any investigational drug within the last 8 weeks before the screening;
• Patients taking any of the non-permitted concomitant medication;
• Subjects unlikely to comply with the study protocol;
• Any clinically relevant abnormal value or physical finding at screening;
• Significant medical history;
• Abnormal and clinically significant 12-lead electrocardiogram;
• Patients with low compliance of QVAR intake.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF1535 NEXThaler 200/6 µg, 1 puff	Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg	Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Placebo NEXThaler	Placebo	Placebo
CHF1535 NEXThaler 200/6 µg, 4 puffs	Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg	Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg
CHF1535 NEXThaler 100/6 µg, 4 puffs	Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg	Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg
CHF1535 NEXThaler 100/6, 1 puff	Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg	Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg

Primary Outcome Measures

Name	Time	Method
FEV1 Area under the curve	until 12 h post dose	FEV1= Forced expiratory volume in the first second of expiration

Secondary Outcome Measures

Name	Time	Method
FEV1 peak	until 12 h post dose	Maximum FEV1 value
FVC area under the curve	until 12 h post dose	FVC = Forced Vital Capacity
FVC peak	until 12 h post dose	Maximum FVC
Adverse events	over a period of 5 to 14 weeks	from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods.

Trial Locations

Locations (3)

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom

Respiratory Clinical Trials, Hearth Lung Centre; 🇬🇧 London, United Kingdom