Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Budesonide 200 µg and
Fenspiride 80 mg: Budesonide 200 µg b.i.d for one week
Budesonide 200 µg b.i.d and Fenspiride 80mg t.i.d for 2 weeks
Control Intervention1: Budesonide 200 Â
Sponsors
Zuventus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participant Inclusion Criteria 1.Male or female patients aged 18 years or older. 2.Diagnosed of moderate persistent asthma which is characterized by a forced expiratory volume in 1 second (FEV1) within prediction of 60 % to 80%. 3.Reversibility in the measurement of peak expiratory flow rate (PEFR) 4.FEV1 > 12% after inhalation of 400 µg salbutamol, and current therapy with inhaled corticosteroid (budesonide 400 µg/day) 5.Ability to perform Spirometry. 6.Patients willing to give written informed consent and willing to comply with trial protocol.
Exclusion criteria
Exclusion criteria: Participant Exclusion Criteria 1.History of other significant respiratory disease or hospitalization due to asthma within 3 months prior to enrollment in the study 2.History of smoking during 6 months preceding enrollment 3.Use of long acting anti histamines, aspirin, barbiturates, analgesics, opioid analgesics, tranquilizers, MAO inhibitors, long acting β2 agonist and alcohol during a week before enrollment in the study 4.Evidences of pulmonary infection on chest radiograph 5.Pregnancy or lactation 6.Any other clinically significant medical condition that may endanger the safety of participant or jeopardize the protocol. 7.Illness severe enough to require hospitalization 8.History of allergy to Fenspiride or similar compounds 9.Current or a History of Cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome â?¢Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study Timepoint: Primary Outcome â?¢Proportion of patients showing an improvement in the severity of clinical symptoms of asthma at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome â?¢Improvement in the Lung function parameters at the end of the study (mean change from the baseline) â?¢Decrease in the use of short acting β2 agonist at the end of the treatment phase. â?¢Assessment of therapy by investigator and patients at the end of the treatment period. â?¢Adverse events reported by the patients during the treatment period. Timepoint: within 14 days of treatment duration | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd
Outcome results
None listed