Low Exhaled NO and ICS in Suspected Asthma

Asthma Clinical Trial

— LowNO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02771717
• Other study ID #: 16013
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 28, 2016
• Last updated: May 12, 2016
• Start date: May 2016
• Est. completion date: July 2018

Study information

• Verified date: May 2016
• Source: University of Nottingham
• Contact: Tim Harrison, MD
• Email: tim.harrison[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide (Pulmicort)
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
• Placebo - dummy inhaler
Placebo - dummy inhaler to be taken 1 puff twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of asthma exacerbations will be recorded for each group and compared.	The number of asthma exacerbations will be captured from verbal feedback from specific patient questioning at study visits.	12 weeks	No
Other	The deterioration in asthma control as measured by ACQ-7 and compared between groups.	deterioration in asthma control will be captured from the ACQ- 7	12 weeks	No
Primary	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	No
Secondary	Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.	FEV1 will be measured in Litres.	overall 12 weeks	No
Secondary	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	No
Secondary	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	No