- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02771717
Low Exhaled NO and ICS in Suspected Asthma (LowNO)
Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Tim Harrison, MD
- Email: tim.harrison@nottingham.ac.uk
Study Contact Backup
- Name: Angela Shone
- Email: angela.shone@nottingham.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 years or over.
- Asthma suspected by GP/Practice Nurse
- Must be able to give informed consent
- Exhaled Nitric Oxide reading <27ppb
- FEV1 >70% predicted
Exclusion Criteria:
- Patients requiring oral steroid treatment on visit to GP/Practice nurse
- Use of oral prednisolone or antibiotics within last 4 weeks
- Already using an inhaled corticosteroid
- Any other clinically significant co-morbidity.
- Expectant or breast feeding mothers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
|
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
|
Placebo Comparator: Placebo - dummy inhaler
|
Placebo - dummy inhaler to be taken 1 puff twice daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
overall 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
overall 12 weeks
|
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.
|
overall 12 weeks
|
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.
|
overall 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
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
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tim Dr Harrison, MD, University of Nottingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
Other Study ID Numbers
- 16013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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