Low Exhaled NO and ICS in Suspected Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide (Pulmicort)
* Drug: Placebo - dummy inhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or over. Asthma suspected by GP/Practice Nurse Must be able to give informed consent Exhaled Nitric Oxide reading <27ppb FEV1 >70% predicted Exclusion Criteria: Patients requiring oral steroid treatment on visit to GP/Practice nurse Use of oral prednisolone or antibiotics within last 4 weeks Already using an inhaled corticosteroid Any other clinically significant co-morbidity. Expectant or breast feeding mothers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide (Pulmicort)<br>Low dose inhaled corticosteroid. | Drug: Budesonide (Pulmicort)<br>* Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily<br>|
| Placebo Comparator: Placebo - dummy inhaler<br>Placebo - dummy inhaler | Drug: Placebo - dummy inhaler<br>* Placebo - dummy inhaler to be taken 1 puff twice daily.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important. | overall 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline. | FEV1 will be measured in Litres. | overall 12 weeks | 
| Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline. | A minimal important difference in LCQ is 1.3. This will be assessed using this validated, self-reported measure of quality of life for cough. | overall 12 weeks | 
| Difference in a subjective measurement of MRC dyspnoea scale. | This is a subjective scale of breathlessness graded 1-5 (5 being most breathless). This will be assessed from baseline measurements. | overall 12 weeks |