Clinical trial NCT02148120: A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler
Official title: A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: FEV1 Area under the curve
timeFrame: until 12 h post dose
Secondary outcomes:
measure: FEV1 peak
timeFrame: until 12 h post dose
measure: FVC area under the curve
timeFrame: until 12 h post dose
measure: FVC peak
timeFrame: until 12 h post dose
measure: Adverse events
timeFrame: over a period of 5 to 14 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
city: London
country: United Kingdom
facility: Respiratory Clinical Trials, Hearth Lung Centre
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
References: