Low Exhaled NO and ICS in Suspected Asthma (LowNO)

University of Nottingham

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo - dummy inhaler; Drug: Budesonide (Pulmicort)

Study type: Interventional

Funder types: Other

Identifiers

NCT02771717

16013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 2 patient groups, including a placebo group

Budesonide (Pulmicort)

Experimental group

Description:

Low dose inhaled corticosteroid.

Treatment:

Drug: Budesonide (Pulmicort)

Placebo - dummy inhaler

Placebo Comparator group

Description:

Placebo - dummy inhaler

Treatment:

Drug: Placebo - dummy inhaler