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
1 other identifier
interventional
165
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started May 2016
Typical duration for phase_4 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedMay 13, 2016
May 1, 2016
1.2 years
April 28, 2016
May 12, 2016
Conditions
Outcome Measures
Primary Outcomes (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.
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 Outcomes (3)
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
overall 12 weeks
Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline.
overall 12 weeks
Difference in a subjective measurement of MRC dyspnoea scale.
overall 12 weeks
Other Outcomes (2)
The incidence of asthma exacerbations will be recorded for each group and compared.
12 weeks
The deterioration in asthma control as measured by ACQ-7 and compared between groups.
12 weeks
Study Arms (2)
Budesonide (Pulmicort)
EXPERIMENTALLow dose inhaled corticosteroid.
Placebo - dummy inhaler
PLACEBO COMPARATORPlacebo - dummy inhaler
Interventions
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
Placebo - dummy inhaler to be taken 1 puff twice daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Dr Harrison, MD
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2016
First Posted
May 13, 2016
Study Start
May 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2018
Last Updated
May 13, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share