This study is designed to compare how safe and effective salmeterol /fluticasone combination is when given with an autohaler or inhaler device in asthma patients
- Conditions
- Health Condition 1: null- Moderate to severe asthma patients
- Registration Number
- CTRI/2011/11/002165
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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.
1. Known or suspected hypersensitivity to combination or any other constituents of the Investigational Medicinal Product (IMP) & study
drugs
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in pre-dose morning PEFRTimepoint: At the end of 12 weeks from baseline
- Secondary Outcome Measures
Name Time Method Change in mean symptom scoresTimepoint: At 2, 4, 8 & 12 weeks;Difference in number of puffs of rescue medicationTimepoint: At the end of 12 weeks;Incidence of Adverse eventsTimepoint: During study period;Incidence of asthma exacerbation, requiring emergency attendance, treatment with oral steroid and hospitalization due to asthma worseningTimepoint: During study period;Incidence of drug related adverse eventsTimepoint: During study period;Mean change in pre-dose evening PEFRTimepoint: At the end of 2, 4, 8 and 12 weeks from baseline;Mean change in pre-dose FEV1Timepoint: At the end of 2, 4, 8 and 12 weeks from baseline;Mean change in pre-dose morning PEFRTimepoint: At the end of 2, 4, 8 weeks from baseline;Proportion of symptom-free days and the proportion of symptom free nightsTimepoint: During study period;Usability questionnaire assessmentTimepoint: During study period