A Phase 4 interventional study of Budesonide (Pulmicort) and Placebo - dummy inhaler in Asthma, sponsored by University of Nottingham. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by University of Nottingham · Phase 4, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 165 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low dose inhaled corticosteroid.
Drug: Budesonide (Pulmicort)
Placebo - dummy inhaler
Drug: Placebo - dummy inhaler
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
Placebo - dummy inhaler to be taken 1 puff twice daily.
Also known as: 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.
Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important.
Time frame: overall 12 weeks
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
FEV1 will be measured in Litres.
Time frame: overall 12 weeks
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.
Time frame: overall 12 weeks
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.
Time frame: overall 12 weeks
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.
Time frame: 12 weeks
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
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Nottingham