Health Condition 1: null- Persistent asthma
Conditions
Interventions
Intervention1: Ciclesonide/Formoterol: 80/4.5 mcg combination pMDI (1 puff twice daily) for 6 weeks.
Control Intervention1: Ciclesonide: 80 mcg pMDI (1 puff twice daily) for 6 weeks.
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Written informed consent. 2.Male or female between 18 and 70 years of age inclusive of both. 3.Confirmed diagnosis of asthma according to GINA guidelines 4.Subjects with documented history of asthma who are either steroid naïve, on ICS+LABA combination or are on ICS (maximum daily dose up to 800 mcg budesonide, 1000 mcg Beclomethasone dipropionate (BDP) or 500 mcg Fluticasone) for at least 4 weeks prior to run-in. 5.FEV1 greater than or equal to 40 percent and Lesser than 80 prcent 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. 6.Able to demonstrate a 12 percent and 200 ml improvement in FEV1 within 30 minutes after inhalation of salbutamol 200 mcg / levosalbutamol 100 mcg unless reversibility is documented in the previous 6 months 7.Able to use the peak flow meter and perform the required pulmonary function tests before entering the run-in period 8.In the opinion of the investigator, able to comply with the requirements of the protocol. 9.The subject should demonstrate correct use of the pMDI.
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to ciclesonide, formoterol or any other constituents of the Investigational Medicinal Product (IMP). 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., 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.Clinically relevant respiratory tract infection, as judged by investigator in the 4 weeks preceding the run-in period. 4.Females who are pregnant, lactating or planning to become pregnant 5.Women of child bearing age who are unwilling to take adequate contraceptive precautions unless abstinence is considered adequate in the investigators opinion 6.Clinically significant laboratory values, as judged by the investigator. 7.Subjects who have previously been enrolled into this study. 8.Receipt of an investigational drug within 30 days prior to study entry (screening visit) 9.Subjects who are scheduled to receive any other investigational drug during the course of the study. 10.Hospitalisation due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit) 11.Use of oral, depot or parenteral steroids within 4 weeks of the run-in period 12.A smoking history of > or = 10 pack years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in morning FEV1Timepoint: At the end of 6 weeks of treatment period vs. baseline visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mean Symptom scoreTimepoint: From baseline visit to 6 weeks of treatment period;Mean diurnal PEFR variationTimepoint: From baseline visit to 6 weeks of treatment period;Mean morning pre-dose PEF valuesTimepoint: From baseline visit to 6 weeks of treatment period;Mean pre dose evening PEF valuesTimepoint: From baseline visit to 6 weeks of treatment period;Proportion of symptom-free days and the proportion of symptom free-nightsTimepoint: From baseline visit to 6 weeks of treatment period;Use of rescue medicationTimepoint: From baseline visit to 6 weeks of treatment period | — |
Countries
India
Contacts
Public ContactDr Sundeep Salvi
Outcome results
None listed