Low Exhaled NO and ICS in Suspected Asthma (LowNO)
|ClinicalTrials.gov Identifier: NCT02771717|
Recruitment Status : Unknown
Verified May 2016 by University of Nottingham.
Recruitment status was: Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Budesonide (Pulmicort) Drug: Placebo - dummy inhaler||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
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 Name: Placebo
- 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. [ Time Frame: overall 12 weeks ]Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important.
- Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline. [ Time Frame: overall 12 weeks ]FEV1 will be measured in Litres.
- Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline. [ Time Frame: 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.
- Difference in a subjective measurement of MRC dyspnoea scale. [ Time Frame: overall 12 weeks ]This is a subjective scale of breathlessness graded 1-5 (5 being most breathless). This will be assessed from baseline measurements.
- The incidence of asthma exacerbations will be recorded for each group and compared. [ Time Frame: 12 weeks ]The number of asthma exacerbations will be captured from verbal feedback from specific patient questioning at study visits.
- The deterioration in asthma control as measured by ACQ-7 and compared between groups. [ Time Frame: 12 weeks ]deterioration in asthma control will be captured from the ACQ- 7
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771717
|Contact: Tim Harrison, MDemail@example.com|
|Contact: Angela Shonefirstname.lastname@example.org|
|Principal Investigator:||Tim Dr Harrison, MD||University of Nottingham|