Low Exhaled NO and ICS in Suspected Asthma

NCT ID: NCT02771717

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-07-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Budesonide (Pulmicort)

Low dose inhaled corticosteroid.

Group Type: EXPERIMENTAL

Budesonide (Pulmicort)

Intervention Type: DRUG

Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily

Placebo - dummy inhaler

Placebo - dummy inhaler

Group Type: PLACEBO_COMPARATOR

Placebo - dummy inhaler

Intervention Type: DRUG

Placebo - dummy inhaler to be taken 1 puff twice daily.

Interventions

Budesonide (Pulmicort)

Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily

Intervention Type: DRUG

Placebo - dummy inhaler

Placebo - dummy inhaler to be taken 1 puff twice daily.

Intervention Type: DRUG

Other Intervention Names

Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Dr Harrison, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Central Contacts

Tim Harrison, MD

Role: CONTACT

tim.harrison@nottingham.ac.uk

Angela Shone

Role: CONTACT

angela.shone@nottingham.ac.uk

Other Identifiers

16013

Identifier Type: -

Identifier Source: org_study_id