Open prospective single arm real practice trial of long term doxycycline in asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in both pre and post FEVI
研究概览
简要总结
Brieffindings: · Actualnumber of patients enrolled 24.
· 10patients are continuing the therapy, but the second Spirometry is pending.
· 4patients consumed inconsistently – dropped and stopped.
· 1patients started very recently – not included
· 2patients had stopped the therapy after a few days without any side effects.
· 1patient was diagnosed TB, Doxycycline stopped.
6patients are incorporated for statistical analysis:
Meanage: 47.0±14.6 years
Meanduration: 162.83±83.07 days
| Before treatment |
After treatment
| Mean ± SD
Mean ± SD
|FEV1(L)(post-bronchodialators)
1.30±0.43
1.61±0.34
Significancep-value = 0.004
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 13.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a)Willing to participate in the trial.
- •b)History of SOB with wheeze with variability (seasonal, diurnal, others) with h/o spontaneous recovery (wellbeing) or relief from oral or inhaled bronchodialators with or without family history of diagnosed or suggestive asthma and / or allergic rhinitis with documentation of airflow limitation with or without reversibility.
- •c)Thus both certain and possible cases of chronic asthmatics will be incorporated.
排除标准
- •i)Age 13 yrs and75yrs ii)Unwillingly for informed written consent iii)H/o doxycycline intolerance iv)Very sick patient unable for follow up.
- •v)Significant Co-morbidity – that can affect the spirometric performance or the synptomatology.
- •vi)FEV160% of predicted value vii)Clinically obvious anemia and HB% if measured 7.0 gm% viii)Pregnancy and lactation ix)Exacerbation in last 6 weeks.
- •x)No other obvious lung disease as assessed by the physician.
结局指标
主要结局
change in both pre and post FEVI
时间窗: preferably at least 6 months of continuation of doxycycline therapy
次要结局
未报告次要终点