A study to compare the effectiveness and safety of two similar asthma drugs. Seroflo® â?? (manufactured by Cipla LTD, India) with Seretide® - (manufactured by Glaxo Wellcome Production, France).
- Conditions
- Health Condition 1: null- Moderate to Severe Asthma
- Registration Number
- CTRI/2015/02/005554
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Subjects or LAR voluntarily willing to give signed informed consent & ready to participate in audio-video consent.
2. Subjects of either sex between 18 and 70 years (both inclusive) of age and with confirmed diagnosis of Asthma (GINA updated 2012).
3. Subject having pre-dose FEV1% of predicted of 50 to 80%
4. Subject is on a stable dose of any asthma medication 4 weeks prior to visit 1.
5. Able to use the peak flow meter, meter dose inhaler and ready to fill daily subject diary through the study period.
1. Clinical evidence or known history of any serious uncontrolled medical condition.
2. Females who are pregnant, lactating or planning to become pregnant.
3. Women of child bearing potential who are unwilling to take adequate contraceptive precautions.
4. Subjects who are currently participating in any other clinical trial or have participated in any clinical trial in last 30 days of visit 1.
5. Subject having hypersensitive to Investigational product or any of the excipients
6. Subject having an exacerbation in past 12 weeks from visit1
7. Subjects who are current or past smoker with a smoking history of >= 10 pack years.
8. Subjects had URTI in past 4 weeks and LRTI in past 12 weeks prior to visit 1.
9. Subject has received an immunotherapy in past 1 year from visit 1.
10. Subject taking any herbal medication in past 30 days prior to visit 1.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in pre dose morning PEFR values recorded after 8 weeks treatment <br/ ><br>Timepoint: At the end of 8 week treatment
- Secondary Outcome Measures
Name Time Method