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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Tim Harrison, MD
- メール：tim.harrison@nottingham.ac.uk
研究連絡先のバックアップ
- 名前：Angela Shone
- メール：angela.shone@nottingham.ac.uk
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
|
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
|
|
プラセボコンパレーター：Placebo - dummy inhaler
|
Placebo - dummy inhaler to be taken 1 puff twice daily.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
時間枠：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.
時間枠：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.
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of asthma exacerbations will be recorded for each group and compared.
時間枠：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.
時間枠：12 weeks
|
deterioration in asthma control will be captured from the ACQ- 7
|
12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Tim Dr Harrison, MD、University of Nottingham
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Budesonide (Pulmicort)の臨床試験
-
Bond Avillion 2 Development LP完了
-
Vectura Limited完了喘鳴 | 反応性気道疾患 | 軽度の喘息アメリカ
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)募集