Health Condition 1: null- Moderate to Severe Asthma
Conditions
Interventions
Intervention1: Seroflo® 250: Seroflo® 250 pMDI(manufactured by Cipla) two puffs
twice daily for a period of 8 weeks
Control Intervention1: Seretide® Evohalertm: Seretide 250 Evohaler® MDI(manufact
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in pre dose morning PEFR values recorded after 8 weeks treatment Timepoint: At the end of 8 week treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| All drug related or non-related AEs and SAEs will be documented.Timepoint: Through out the study period;Difference in number of patients with Asthma Control between both the groups - Asthma control will be determined based on day time & nocturnal symptoms, limitation of activities, need of reliever treatment, No exacerbation and normal PEF as defined in GINA Guidelines updated 2012.Timepoint: From week 4 to week 8;Difference in number of puffs of rescue medication used / dayTimepoint: At end of 8 weeks from baseline;Incidence of asthma exacerbation requiring emergency attendance, treatment with oral steroid and hospitalizationTimepoint: Through out the study period;Mean change in pre dose evening PEFRTimepoint: Baseline to subsequent visits;Mean change in pre dose morning PEFRTimepoint: At the end of 2, 4 & 8 weeks from baseline;Mean change in pre-dose FEV1 and FVCTimepoint: At the end of 8 weeks treatment;Proportion of symptom-free days and the proportion of symptom free nightsTimepoint: Baseline to subsequent visits | — |
Countries
India
Contacts
Public ContactAbhijit Vaidya
Cipla Ltd.
Outcome results
None listed