sing FeNO to optimally manage asthma

Not Applicable

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN17718575
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-14
• Study Completion: 2023-08-31
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or above
3. Either (i) newly presenting with a possible diagnosis of asthma or (ii) having been previously diagnosed with asthma
and taking high dose inhaled corticosteroids
4. Able to use the NiOX FeNO monitoring equipment

Exclusion Criteria

1. Cannot give informed consent
2. Unable to obtain a satisfactory FeNO level recording
3. Severe life-threatening condition or one that would be anticipated to lead to death or disability within 1 year of study period
4. Current history of primary lung malignancy or current active pulmonary TB
5. Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject's ability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma control in the previous 2 weeks, assessed using the Asthma Control Test (ACT) at baseline, at 30 days and at 60 days and at 1 year.

Secondary Outcome Measures

Name	Time	Method
All outcomes are measured at first visit, 30 days, 60 days and 360 days:<br>1. Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)<br>2. Peak expiratory flow rate (PEFR) measured for 2 weeks, twice a day, after each visit; recorded on diary cards<br>3. Subject anxiety and depression measured using the Hospital Anxiety and Depression (HAD) questionnaire (self-administered) at each visit<br>4. Healthcare utilisation collected by the research team by taking a history from the patients and using primary care records<br>5. Changes to treatment (dose or drug) collected by the research staff from patient history as well as primary care records<br>6. Healthcare economic impact assessment performed using the data collected above by a professional healthcare economist<br>7. The number of asthma attacks (exacerbations) collected through interview and GP records<br>8. Disease-related healthcare mastery measured using the Healthcare Mastery score