AsthmaPhase 4LowNONCT02771717
Low Exhaled NO and ICS in Suspected Asthma
A Phase 4 study testing Budesonide (Pulmicort) in people with Asthma, run by University of Nottingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide (Pulmicort)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Tim Harrison, MD contact
Angela Shone contact
About this study
Official title: Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Budesonide (Pulmicort), Placebo - dummy inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide (Pulmicort)Drug
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
Placebo - dummy inhalerDrug
Also called Placebo
Placebo - dummy inhaler to be taken 1 puff twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide (Pulmicort) | Experimental | Low dose inhaled corticosteroid. Receives: Drug: Budesonide (Pulmicort) |
| Placebo - dummy inhaler | Placebo comparator | Placebo - dummy inhaler Receives: Drug: Placebo - dummy inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: overall 12 weeks
Secondary outcomes (3)
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
FEV1 will be measured in Litres.
Measured: 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.
Measured: 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.
Measured: overall 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Dr Harrison, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771717
- Sponsor's protocol ID
- 16013
- Acronym
- LowNO
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02771717
- Acronym / sponsor ID
- LowNO / 16013
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide (Pulmicort) | Experimental | Drug: Budesonide (Pulmicort)Low dose inhaled corticosteroid. |
| Placebo - dummy inhaler | Placebo comparator | Drug: Placebo - dummy inhalerPlacebo - dummy inhaler |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide (Pulmicort)Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily | Drug | Budesonide (Pulmicort) |
| Placebo - dummy inhalerAlso: PlaceboPlacebo - dummy inhaler to be taken 1 puff twice daily. | Drug | Placebo - dummy inhaler |
Primary outcome
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.
3 secondary outcomes
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
Time frame: overall 12 weeks
Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline.
Time frame: overall 12 weeks
Difference in a subjective measurement of MRC dyspnoea scale.
Time frame: overall 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Harrison, MD contact
Angela Shone contact
Tim Dr Harrison, MD principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide (Pulmicort) in people with Asthma, run by University of Nottingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim Harrison, MD (tim.harrison@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.