The Evaluation of FeNO for Predicting Response to ICS in Subjects With Non-specific Respiratory Symptoms

NCT02294279 | Completed Phase 4

• 1 other identifier: OR01013
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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 confirmation of an asthma diagnosis and can indicate the degree of steroid-responsiveness. This can help guide physician decisions on the initiation of inhaled corticosteroid (ICS) therapy, or adjustment of ICS therapy. Therefore, FeNO measurement could be particularly useful to confirm an asthma diagnosis in patients with non-specific respiratory symptoms (≥ 6 weeks of cough and/or wheezing and/or chronic dyspnoea) and to assess how likely they are to benefit from corticosteroid treatment. This study will assess the suitability of FeNO to predict ICS responsiveness in patients with non-specific respiratory symptoms. Additionally, we would like to determine the suitability of FeNO as a diagnostic tool for asthma in comparison to conventional predictors, e.g. spirometry.

Conditions

Asthma

Keywords

cough, wheeze, dyspnoea

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire (ACQ)

  The Asthma control questionnaire (ACQ) is a seven question (i.e. the top scoring 5 symptoms, daily rescue bronchodilator use and FEV1% pred.), validated tool for assessing asthma control. Patients are asked to recall how their asthma has been during the last 7 days and to evaluate their asthma against 5 symptom questions and a rescue bronchodilator use question on a 6-point scale (0 = no impairment, 6 = maximum impairment). In addition, the research nurse will grade the FEV1 % predicted on a 6 point scale (0 to 6). The questions are equally weighted and ACQ7 score is the mean of the 7 questions, generating a value between 0 (totally controlled) and 6 (severely uncontrolled).

  Baseline and 4 weeks

Secondary Outcomes (6)

• EuroQol 5 dimension questionnaire

  Baseline and 4 weeks

• Visual Analogue Scale test (VAS) and cough Visual analogue scale test

  Baseline and 4 weeks

• Spirometry (PEF, FEV1, FVC, FEV1/FVC)

  3 days

• Eosinophil analysis

  1 day

• Peak expiratory flow (PEF diary)

  From visit 1 till 6 weeks follow-up (2 recordings per day over 6 weeks)

Study Arms (2)

Active

EXPERIMENTAL

4 weeks of corticosteroid treatment with QVAR (100mcg), 400 mcg daily; two puffs twice daily

Drug: Qvar (100 mcg)

Placebo

NO INTERVENTION

Blinded placebo inhaler

Interventions

Qvar (100 mcg) DRUG

2 puffs twice daily; 400 mcg daily over 4 weeks treatment period

Also known as: Beclomethasone diproprionate

Active

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Aerocrine AB: collaborator

Study Sites (1)

Research in Real Life Ltd

Oakington, Cambridgeshire, CB24 3BA, United Kingdom

Location

Related Publications (1)

• Price DB, Buhl R, Chan A, Freeman D, Gardener E, Godley C, Gruffydd-Jones K, McGarvey L, Ohta K, Ryan D, Syk J, Tan NC, Tan T, Thomas M, Yang S, Konduru PR, Ngantcha M, d'Alcontres MS, Lapperre TS. Fractional exhaled nitric oxide as a predictor of response to inhaled corticosteroids in patients with non-specific respiratory symptoms and insignificant bronchodilator reversibility: a randomised controlled trial. Lancet Respir Med. 2018 Jan;6(1):29-39. doi: 10.1016/S2213-2600(17)30424-1. Epub 2017 Nov 3.

  PMID: 29108938 DERIVED

MeSH Terms

Conditions

Asthma; Cough; Respiratory Sounds; Dyspnea

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• David Price, Prof

  Research in Real Life

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

GB (1)