ISRCTN46346208已完成未知
A multi-centre randomised, double-blind, placebo-controlled, parallel-group trial of the effectiveness of the nocturnal use of a Temperature Controlled Laminar Airflow (TLA) Device (Airsonett®) in adults with poorly-controlled, severe allergic asthma
Queen Alexandra Hospital (UK)0 个研究点目标入组 240 人开始时间: 2014年1月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26743812 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31232684 (added 25/06/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 24/07/2015:
- •1. Adults (aged 16-75 years inclusive)
- •2. A clinical diagnosis of asthma for =6 months supported by evidence of any one of the following:
- •2.1. Airflow variability with a mean diurnal peak expiratory flow (PEF) variability >15% during the baseline 2-week period or a variability in FEV1 of >20% across clinic visits within the preceding 12 months, with concomitant evidence of airflow obstruction (FEV1/FVC ratio <70%);
- •2.2. Airway reversibility with an improvement in FEV1 by =12% or 200 ml after inhalation of 400 µg of salbutamol via a metered dose inhaler and spacer at first study visit or within the preceding 12 months;
- •2.3. Airway hyper-responsiveness demonstrated by Methacholine challenge testing with a provocative concentration of Methacholine required to cause a 20% reduction in FEV1 (PC20) of =8mg/ml or equivalent test (See Appendix 3).
- •3. Severe asthma:
- •3.1. Requirement for high-dose inhaled corticosteroids (ICS) (=1000µg/day beclomethasone (BDP) or equivalent – see Appendix 4) plus a second controller (long-acting ß2-agonist or anti-muscarinic, theophylline, or leukotriene antagonist), and/or systemic corticosteroids.
- •3.2. If on maintenance corticosteroids, the maintenance dose must have been stable for 3-months– this excludes any interim need for short-term steroid bursts to treat exacerbations.
- •4. Poorly controlled asthma demonstrated by BOTH:
- •4.1. =2 severe asthma exacerbations, requiring systemic corticosteroids =30mg prednisolone or equivalent daily (or =50% increase in dose if maintenance 30mg prednisolone or above), for 3 or more days, during the previous 12 months, despite the use of high-dose inhaled corticosteroids (ICS) and additional controller medication;
- •4.2. ACQ (7-point) score >1 at Screening Visit 1 and Randomisation Visit 2.
- •5. Atopic status:
- •5.1. Sensitisation to =1 perennial indoor aeroallergen[2] (including House Dust Mite, domestic pet or fungi) to which they are likely to be exposed during the study, demonstrated by a positive skin prick test (wheal diameter =3mm more than negative control) or specific IgE =0.35 IU/L).
- •6. Exacerbation free and taking stable maintenance asthma medications (not including short-acting bronchodilator or other reliever therapies) for at least 2-weeks prior to Screening Visit 1
- •7. Exacerbation free and taking stable maintenance asthma medications (not including short-acting bronchodilator or other reliever therapies) in the period between Screening Visit 1 and Randomisation Visit 2.(the Screening Period). Participants suffering a severe exacerbation during the Screening Period can be rescreened 2 weeks after returning to their maintenance asthma medications (See 11.3.2)
- •8. Able to use the TLA device during sleep on at least five nights per week (excluding holidays)
- •9. Able to understand and give written informed consent prior to participation in the trial and able to comply with the trial requirements
- •Previous inclusion criteria:
- •1. Adults (aged 18-75 years inclusive)
- •2. A clinical diagnosis of asthma for =6 months prior to trial entry supported by evidence of either:
- •2.1. Airflow variabili
排除标准
- •1. Current smokers or ex-smokers abstinent for <6 months
- •2. Ex-smokers with =15 pack year smoking history
- •3. Partner who is a current smoker and smokes within the bedroom where the TLA device is installed
- •4. TLA device cannot be safely installed within the bedroom, intending to move out of study area within the trial period or unable to use the TLA device for at least 8 hours on at least 5 nights per week
- •5. Documented poor treatment adherence
- •6. Occupational asthma with continued exposure to known sensitising agents in the workplace
- •7. Previous bronchial thermoplasty within 12 months
- •8. Maintenance treatment with Omalizumab (anti-IgE) within 3 months
- •9. Using long-term oxygen, Continuous Positive Airway Pressure (CPAP) or Non-Invasive Ventilation (NIV) routinely overnight as this will impair the effect of the TLA device
- •10. Uncontrolled symptomatic gastro-oesophageal reflux that may act as a persistent asthma trigger
- •11. Presence of clinically significant lung disease other than asthma, including smoking-related chronic obstructive pulmonary disease (COPD), bronchiectasis associated with recurrent bacterial infection, allergic bronchopulmonary aspergillosis (mycosis), pulmonary fibrosis, sleep apnoea, pulmonary hypertension, or lung cancer
- •12. Patients with clinically significant co-morbidity (including cardiovascular, endocrine, metabolic, gastro-intestinal, hepatic, neurological, renal, haematological and malignant conditions) that remains uncontrolled with standard treatment
- •13. Patients currently taking part in other interventional clinical trials
研究者
相似试验
已完成
不适用
Evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage.Topic: Injuries and Emergencies, HaematologySubtopic: Injuries and Emergencies (All Subtopics), Haematology (All Subtopics)Disease: Injuries and Emergencies, Non-malignant HaematologyInjury, Occupational Diseases, PoisoningISRCTN67540073HS Blood and Transplant (NHSBT)48
已完成
2 期
Investigating the effects of dietary nitrate in patients with stable anginaTopic: Cardiovascular diseaseSubtopic: Cardiovascular (all Subtopics)Disease: Cardiovascular PreventionCirculatory SystemCardiovascular disease preventionISRCTN17373946Queen Mary University of London246
已完成
2 期
Repurposing anti-TNF for treating Dupuytren’s diseaseDupuytren's disease of the handSkin and Connective Tissue DiseasesDupuytren's diseaseISRCTN27786905niversity of Oxford181
已完成
不适用
A multicentre, randomized, double-blind, placebo-controlled, parallel-design trial of the efficacy and safety of subcutaneous tetrodotoxin (Tectin) for moderate to severe inadequately controlled cancer-related paiCancer- and cancer therapy-related painCancer painCancerISRCTN75684296Wex Pharmaceuticals Inc (Canada)82
已完成
3 期
Study of mirtazapine for agitation in dementiaISRCTN17411897niversity of Sussex247