Health Condition 1: null- Moderate to severe Asthma
Conditions
Interventions
Intervention1: Fluticasone / Formoterol: 125/6 mcg administered through a pressurized metered dose inhaler two puffs twice daily
Control Intervention1: Budesonide / Formoterol: 200/6 mcg administered
Sponsors
Cipla Ltd Bellasis Road Mumbai Central Mumbai Phone Fax
Eligibility
Inclusion criteria
Inclusion criteria: 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 >= 12% & >=200 ml, 20 minutes post administration of 200 μg Levosalbutamol delivered by pressurized metered dose inhaler (pMDI) with spacer. 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 run-in. 5. FEV1 >= 40% and 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 12 hours prior to screening visit. 6. Able to use the Peak Flow Meter, pressurized metered dose inhaler (pMDI) with zerostat VT spacer and perform the spirometry as per the study requirement before entering the run-in period. 7. In the opinion of the investigator, able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 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 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 investigator?s opinion. 8.Clinically significant laboratory values, as judged by the investigator. 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). 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). 13.Use of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to the run-in period. 14.Current smoker or past smoker with a smoking history of more than or equal to 10 pack years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in pre dose morning PEF values recorded over the 12 weeks treatment period.(measured daily, using the Peak Flow Meter)Timepoint: 12 weeks from the baseline visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Diurnal PEFR variationTimepoint: From baseline visit to 12 weeks of treatment period;Mean change in FEV1 at the end of 2, 4, 8 & 12 weeksTimepoint: From baseline visit to each treatment visit;Mean change in pre-dose evening PEFRTimepoint: From baseline visit to 12 weeks of treatment period;Mean change in pre-dose morning PEFRTimepoint: From baseline visit to each treatment visit;Number of puffs of rescue medicationTimepoint: From baseline visit to 12 weeks of treatment period;Proportion of symptom-free days and the proportion of symptom free-nightsTimepoint: From baseline to 12 weeks treatment period | — |
Countries
India
Contacts
Public ContactDr Salil Bhargava
Cipla Ltd
Outcome results
None listed