Clinical trial NCT02771717: Low Exhaled NO and ICS in Suspected Asthma
Official title: Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a low exhaled nitric oxide reading (\<27ppb) is a good predictor of a negative response to inhaled steroid treatment for patients with symptoms suggestive of asthma.

Detailed description: At the first visit, which will take place at either at the GP surgery or the Nottingham Respiratory Research Unit (NRRU) informed written consent for the study will be obtained. The patients will then have an exhaled NO measurement, spirometry, venepuncture (for Full Blood Count and research blood - if consent obtained) taken and complete an Asthma Control Questionnaire (ACQ), Medical Research Council dyspnoea scale (MRC) and Leicester Cough Questionnaire (LCQ). All procedures will be carried out by the NRRU research nurse.

The investigators may use the NRRU existing database of research volunteers to recruit as necessary and also the respiratory clinics held at the NUH. If patients from clinics are recruited they will be initially approached by their usual care doctor and an information sheet will be sent / given to them accordingly.

If all the inclusion criteria are met and none of the exclusion criteria, the patients will be randomised to receive either a placebo inhaler, to be taken one puff twice daily, or a low dose inhaled steroid treatment, Budesonide 200mcgs via Turbuhaler one puff twice daily, for 3 months. Dr Tim Harrison will be prescribing the inhalers and they will be dispensed from the Nottingham City Hospital Clinical Trials Pharmacy and delivered/given to the patient by the research nurses.

Participants will be asked to return for follow up visits at 4 weeks, 8 weeks and 12 weeks following randomisation. At these follow up visits, exhaled NO, spirometry and the 3 questionnaires will be repeated.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or over.
2. Asthma suspected by GP/Practice Nurse
3. Must be able to give informed consent
4. Exhaled Nitric Oxide reading \<27ppb
5. FEV1 \>70% predicted

Exclusion Criteria:

1. Patients requiring oral steroid treatment on visit to GP/Practice nurse
2. Use of oral prednisolone or antibiotics within last 4 weeks
3. Already using an inhaled corticosteroid
4. Any other clinically significant co-morbidity.
5. Expectant or breast feeding mothers.

Primary outcomes:
measure: Difference in Asthma Control Questionnaire (ACQ-7) between the inhaled steroid and placebo group adjusted for differences in baseline. The ACQ will measure the level of asthma control in the ICS and placebo group.
timeFrame: overall 12 weeks
Secondary outcomes:
measure: Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
timeFrame: overall 12 weeks
measure: Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline.
timeFrame: overall 12 weeks
measure: Difference in a subjective measurement of MRC dyspnoea scale.
timeFrame: overall 12 weeks
Other outcomes:
measure: The incidence of asthma exacerbations will be recorded for each group and compared.
timeFrame: 12 weeks
measure: The deterioration in asthma control as measured by ACQ-7 and compared between groups.
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: University of Nottingham
name: Tim Dr Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References: