CTRI/2011/11/002165已完成4 期
A 12 weeks, randomized, double-blind, double-dummy, prospective, active-controlled, parallel group, multicenter study to determine safety, tolerability and efficacy of salmeterol/fluticasone combination given by Autohaler versus salmeterol/fluticasone given by a pressurized meter dose inhaler in moderate to severe asthma patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects willing to give written informed consent.
- •2. Subjects of either sex between 18 and 65 years of age.
- •3. Confirmed diagnosis of asthma according to GINA guidelines. [Subjects demonstrating reversibility (FEV1) of greater than or equal to 12% & greater than or equal to 200 ml, 20 minutes post administration of 200 mcg Levosalbutamol delivered by pressurized metered dose inhaler (pMDI). Documented reversibility within the last 6 months is acceptable]
- •4. Subjects with documented history of asthma for at least the past 6 months who are on stable dose of ICS or ICS + LABA for at least 4
- •weeks prior to screening visit 1.
- •5. FEV1 greater than or equal to 50% and less than or equal to 80% of the predicted normal value (as per the European Community for Coal and Steel formula and applying the correction factor of 0.9) when not taking short-acting bronchodilator medication for the previous 6 hours and ICS + LABA combination 24 hours prior to screening visit-2
- •6. Able to use the Peak Flow Meter, breathe actuated inhaler, pressurized metered dose inhaler (pMDI) and perform the spirometry as per the study requirement before entering the run-in period.
排除标准
- •1. Known or suspected hypersensitivity to combination or any other constituents of the Investigational Medicinal Product (IMP) & study
- •2. Clinical evidence or known history of any serious uncontrolled medical condition [e.g. cardiovascular (high pulse rate, irregular heart beat, high blood pressure), renal, neurological, hepatic, immunological, neoplastic, gastrointestinal, or endocrine disease] or any clinically significant abnormality (e.g. eczema, dermatitis, pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease(COPD) or pneumothorax), which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
- •3. Subjects receiving immunotherapy
- •4. Receipt of any herbal medication 30 day prior to the screening visit-1
- •5. Clinically relevant upper respiratory tract infection 4 weeks prior or lower respiratory tract infection 8 weeks prior to the screening visit as judged by investigator.
- •6. Females who are pregnant, lactating or planning to become pregnant.
- •7. Women of child bearing potential who are unwilling to take adequate contraceptive precautions unless abstinence is considered adequate in the investigatorâ??s opinion.
- •8. Clinically significant laboratory values observed at
- •screening visit-2
- •9. Subjects who have previously been randomized into this study.
- •10. Receipt of any other clinical trial drug within 30 days prior to study entry (screening visit-1)
- •11. Subjects who are scheduled to receive any other investigational drug during the course of the study.
- •12. Hospitalisation due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit-1).
- •13. Use of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to the screening visit-1
- •14. Current smoker or past smoker with a smoking history of greater than or equal to 10 pack years
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