A Proof of Concept Study to Evaluate Effects of Intranasal Salmeterol and Fluticasone Given Alone and in Combination in Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Peak Nasal Inspiratory Flow (PNIF).
研究概览
简要总结
Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the population worldwide. It has been reported as being one of the 10 most common causes for attendance to primary care clinics. It is clinically defined as a symptomatic disorder of the nose induced by an IgE mediated inflammation following allergen exposure of the membranes lining the nose and is characterized by varying combinations of nasal symptoms including sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids form the cornerstone of anti-inflammatory therapy in allergic rhinitis and there is increasing interest in the role of intranasal beta 2 agonists in the management of allergic rhinitis. The question therefore arises as to whether salmeterol exhibits such synergistic activity in the nose in terms of potentiating the steroid response of fluticasone.
详细描述
In vitro and ex vitro data have suggested that salmeterol may exhibit ligand independent activation of glucocorticoid receptors, which might result in potentiation of fluticasone by salmeterol when given in combination.
Although no such evidence of synergy was reported with fluticasone salmeterol combination in the nose with allergen challenge, no data are available on nasal AMP challenge in the nose.
This study compares the single and long term dosing effects of intranasal fluticasone alone, salmeterol alone and fluticasone salmeterol combination on nasal AMP challenge in persistent allergic rhinitis sufferers.
Nasal corticosteroid,leukotriene receptor antagonist and anti histamine stopped for one week before the start of randomized treatment during the run in phase and wash out periods. Intransal sodium cromoglycate spray provided for rescue use throughout the study but witheld for at least twenty four hours before challenge.
Nasal AMP challenges performed at baseline, after run-in and each washout, and 12 hours after the first and last evening dose of the study medication. A Zerostat Antistatic spacer (Cipla, Mumbai, India) used to administer the randomized treatments, adapted with a nasal olive for intranasal use instead of the conventional mouthpiece.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Persistent allergic rhinitis without asthma.
- •Atopy to at least 1 allergen on SPT.
- •≥ 20% drop in PNIF following nasal AMP challenge
- •Male to female aged 18-65
- •Informed Consent
- •Ability to comply with the protocol
排除标准
- •Severe allergic rhinitis as defined by those in whom there are symptoms which significantly impair day to day activities on QOL questionnaire.
- •Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
- •PNIF < 60 litres/min
- •The use of oral corticosteroids within the last 3 months.
- •Recent respiratory tract / sinus infection (2 months).
- •Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
- •Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
- •Any significant abnormal laboratory result as deemed by the investigators
- •Pregnancy, planned pregnancy or lactation
- •Known or suspected contra-indication to any of the IMP's
- •Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
研究组 & 干预措施
Fluticasone Proprionate
The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.
干预措施: FLUTICASONE PROPRIONATE (Drug)
Salmeterol
The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.
干预措施: Salmeterol (Drug)
placebo
The participants will be randomised and at each study visit, will receive a single inhaler which can either be active or placebo.
干预措施: PLACEBO (Drug)
结局指标
主要结局
Change in Peak Nasal Inspiratory Flow (PNIF).
时间窗: Change from baseline at 1 week.
Maximum change in PNIF following nasal adenosine monophoshate (AMP) challenge testing for active groups versus placebo.. Data will be presented as % change between groups.
次要结局
- Overnight urinary cortisol/creatinine.(Change from baseline at 1 week.)
- Nasal symptom scores.(Change from baseline at 1 week.)
- Nasal nitric oxide.(Change from baseline at 1 week.)
- Nasal impulse oscillometry.(Change from baseline at 1 week.)
- Eosinophil cationic protein (ECP)(Change from baseline at 1 week.)