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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Tim Harrison, MD
- 이메일: tim.harrison@nottingham.ac.uk
연구 연락처 백업
- 이름: Angela Shone
- 이메일: angela.shone@nottingham.ac.uk
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
|
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
|
|
위약 비교기: Placebo - dummy inhaler
|
Placebo - dummy inhaler to be taken 1 puff twice daily.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
기간: 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.
기간: 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.
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The incidence of asthma exacerbations will be recorded for each group and compared.
기간: 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.
기간: 12 weeks
|
deterioration in asthma control will be captured from the ACQ- 7
|
12 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Tim Dr Harrison, MD, University of Nottingham
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 16013
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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