Status:
COMPLETED
The Evaluation of FeNO for Predicting Response to ICS in Subjects With Non-specific Respiratory Symptoms
Lead Sponsor:
Research in Real-Life Ltd
Collaborating Sponsors:
Aerocrine AB
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Nitric Oxide is recognized as a biological marker for many chronic airway diseases. It has been standardised for clinical use indicating airway inflammation. In clinical practice, FeNO can aid confir...
Detailed Description
Randomised, double-blind, placebo-controlled trial with planned enrolment of 264 patients from the UK and Singapore. Eligible patients are 18-80 years old with ≥6 weeks' duration of non-specific respi...
Eligibility Criteria
Inclusion
- Written informed consent is obtained before conducting any study-related procedures
- The patient is a man or woman aged 18 to 80 years as of the screening visit
- The patient is experiencing non-specific respiratory symptoms defined as follows: Cough and/or wheeze and/or chronic dyspnoea for ≥ 6 weeks prior to visit 1
- Patients displaying an FEV1\< 90% predicted at visit 1, will also need to show a reversibility to a short-acting beta-agonist of \< 20% at visit 1 or within the previous year
- Women of childbearing potential (post-menarche or less than 2 years post-menopausal or not surgically sterile) must be willing to commit to using a medically accepted method of contraception for the duration of the study. Accepted methods of contraception include: intrauterine devices (IUD), systemic contraception e.g. steroidal contraceptives (oral, implanted transdermal or injected), barrier methods with spermicide, and partner vasectomy
Exclusion
- The patient has ever been diagnosed with asthma as evidenced by the UK quality outcome framework approved Read code as well as a reversibility of ≥ 20% predicted
- The patient has received oral, inhaled or systemic corticosteroids, a leukotriene modifier or long-acting-beta-agonist within four weeks prior to visit 1. All therapy and treatment other than those outlined are permitted during the study
- The patient has a significant chronic respiratory disorder other than asthma, e.g. COPD (fixed obstruction, post-bronchodilator) cystic fibrosis, severe and untreated bronchiectasis or interstitial lung disease
- The patient has a significant medical condition that would make it unlikely for the patient to complete the study
- The patient has a known significant risk factor for cough or wheeze, including but not limited to: taking an ACE inhibitor, severe untreated rhinitis, or significant gastroesophageal reflux disease
- The patient is asymptomatic (ACQ \< 1) after the initial 2-week assessment
- The patient has had a respiratory tract infection as judged clinically, within four weeks prior to visit 1, or displays an acute respiratory tract infection at the time of the study
- The patient is a pregnant woman or intends to get pregnant (Any woman becoming pregnant during the study will be withdrawn from the study)
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02294279
Start Date
May 1 2014
End Date
August 1 2016
Last Update
April 25 2017
Active Locations (1)
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1
Research in Real Life Ltd
Oakington, Cambridgeshire, United Kingdom, CB24 3BA