Targeted Small Airways Therapy in Persistent Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Asthma Control Questionnaire score from post-run-in baseline
研究概览
简要总结
The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such as peak flow.
The airways (breathing tubes) in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger 'central' airways and don't provide information on the smaller 'peripheral' airways.Newer measurements have been developed that can now give us accurate information on how the smaller airways are working.Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing.
Recently, new types of steroid inhalers have been developed that have a much smaller particle size than other standard inhaled steroids.These have been shown to go deeper into the lungs, thus getting into the smaller airways. There have been a few studies suggesting that this might improve asthma control. However, we do not know if when small airway function is shown to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether by improving small airway function specifically this translates into improved asthma control.
In this study we wish to study asthmatic patients who are not completely controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing to the same dose of an extra-fine particle inhaled steroid instead will improve asthma control by getting deeper into the lungs and improving small airway function.
详细描述
A single centre, open-label, single subject study over a 12-24 week period. Invited participants will receive a written 'Participant Information Sheet' (PIS) detailing the requirements of the trial and the extent of their participation before attending for a screening visit. Participants will be given at least 24 hours to read the PIS.
Prior to screen (and any subsequent challenge visit) participants will withhold LABAs (or combination inhaler containing LABA) for 48 hours; and salbutamol for 6 hours. Verbal consent will be obtained from the patient over the telephone for withholding medications prior to screen and it will be explained that this in no way means they have consented to the full study at this stage.
At the screening visit a member of the research team will discuss the PIS with the participant, answer any questions posed and written informed consent will be obtained and witnessed by the member of staff asking for the consent of the patient.
A general physical examination will be carried out by a qualified medical practitioner.
A pregnancy test will be performed on all female patients with advice issued to both male and female participants to use contraception throughout the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers aged 18-65, with persistent asthma
- •Asthma Control Questionnaire score >1.0 (at end of run-in)
- •FEV1 >60% predicted
- •R5>130% predicted and R5-R20>0.03kPa/L/s
- •Ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
- •Ability to give informed consent
- •Asthmatic patients receiving treatment at Step 2, 3, or 4 of British Thoracic Society asthma guidelines
- •Ability to withhold long-acting beta-agonists for the duration of the study
排除标准
- •Patients already receiving extra-fine particle inhaled corticosteroids (Qvar, Fostair, Alvesco)
- •Pregnancy or lactation
- •Known or suspected sensitivity to the Investigational Medicinal Product
- •Inability to comply with protocol
- •Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
- •An asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
- •Participation in previous trial within 30 days
研究组 & 干预措施
Qvar® (beclometasone dipropionate HFA)
Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period.
干预措施: Qvar® (beclometasone dipropionate HFA) (Drug)
结局指标
主要结局
Change in Asthma Control Questionnaire score from post-run-in baseline
时间窗: 8 weeks
次要结局
- Impulse oscillometry(8 weeks)
- Blood eosinophilic cationic protein(8 weeeks)
- Blood eosinophils(8 weeks)
- Exhaled Nitric Oxide(8 weeks)
- Mannitol PD15(8 weeks)
- Overnight urinary cortisol/creatinine ratio(8 weeks)
- Domiciliary peak expiratory flow(8 weeks)
- Symptoms and reliever use(8 weeks)
- Mini Asthma Quality of Life Questionnaire(8 weeks)
- Spirometry(8 weeks)
研究者
Brian J Lipworth
Professor of Allergy and Immunology
University of Dundee