LowNO: Low Exhaled NO and ICS in Suspected Asthma

• Sponsor: University of Nottingham (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02771717
• Collaborator: (none)
• Enrollment: 165
• Arms: 2
• Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Budesonide (Pulmicort); Drug: Placebo - dummy inhaler	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide (Pulmicort) Low dose inhaled corticosteroid.	Drug: Budesonide (Pulmicort); Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
Placebo Comparator: Placebo - dummy inhaler Placebo - dummy inhaler	Drug: Placebo - dummy inhaler; Placebo - dummy inhaler to be taken 1 puff twice daily.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. 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. [overall 12 weeks]

   Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important.

Secondary Outcome Measures

1. Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline. [overall 12 weeks]

   FEV1 will be measured in Litres.

2. Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline. [overall 12 weeks]

   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.

3. Difference in a subjective measurement of MRC dyspnoea scale. [overall 12 weeks]

   This is a subjective scale of breathlessness graded 1-5 (5 being most breathless). This will be assessed from baseline measurements.

Other Outcome Measures

1. The incidence of asthma exacerbations will be recorded for each group and compared. [12 weeks]

   The number of asthma exacerbations will be captured from verbal feedback from specific patient questioning at study visits.

2. The deterioration in asthma control as measured by ACQ-7 and compared between groups. [12 weeks]

   deterioration in asthma control will be captured from the ACQ- 7

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Nottingham

Investigators

• Principal Investigator: Tim Dr Harrison, MD, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT02771717
• Other Study ID Numbers: 16013
• First Posted: May 13, 2016
• Last Update Posted: May 13, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Asthma; Budesonide

Study Results

No Results Posted as of May 13, 2016