A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

Study Identifier:
CCD-01535BA1-01
ClinicalTrials.gov Identifier:
NCT02148120
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
  • Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
  • Drug: Placebo
Date
Apr 2014 - Oct 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion 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.
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW
Status
N/A
Location
Respiratory Clinical Trials, Hearth Lung Centre
London, United Kingdom, W1G 8HU
Status
N/A
Location
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Status
N/A