Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Ciclesonide
Metered-dose inhaler: 1 inhalation of 160 mcg/dose BID
Control Intervention1: Ciclesonide, Alvesco (Metered-dose inhaler): 1 inhalation of 160 mcg/dose BID
Sponsors
PSK Pharma LLC
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: ACQ-5 asthma control test result: >= 0.75 and Forced expiratory volume - 1 second (FEV1) before the use of broncholytics not less than 60% of proper value (at screening visit or at the moment of test within 30 days before screening visit). Positive result of the test for reversibility of airway obstruction, expressed as Î?FEV1 >=12% and >=200 ml vs. baseline 30 minutes after the use of 400 µg of Salbutamol. Signed Informed consent form for participation in the clinical study in the Patients Information Sheet
Exclusion criteria
Exclusion criteria: Patients with the need for selection of initial maintenance therapy of BA. Contraindications to the use of iGCS, hypersensitivity to Ciclesonide, Salbutamol or any components of the study product Use of glucocorticosteroids, either oral or for parenteral administration, less than 2 months before the screening visit (3 months for parenteral long-acting GCS). Use of immunosuppressors less than 4 weeks before the screening visit (e.g. cyclosporine, methotrexate, anti-tumor necrosis factor α-receptors (TNF), gold preparations, azathioprine etc.). Conditions requiring the use of systemic GCS at the time of the screening visit. Unexpected and progressive deterioration of control of symptoms of BA. Unstable course of bronchial asthma, hospitalization due to exacerbation of bronchial asthma in the intensive care unit using intubation, frequent exacerbations of asthma Pulmonary tuberculosis (active or inactive form). Fungal, viral or bacterial respiratory infections or systemic viral infections, herpetic ocular lesions (Herpes simplex) at the time of the screening visit. Infection of the lower respiratory tract less than 1 month before the screening visit. 1Cystic fibrosis, bronchiectasis, pneumoconiosis. Restrictive type breathing disorders. Uncontrolled hypokalemia, hypocalcemia. Thyrotoxicosis. Decompensated diabetes mellitus. Osteoporosis. Glaucoma, cataract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the PEF1 valueTimepoint: Visits 1 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FEV1 value Timepoint: 2 hours after the inhalation of the study/reference product.;Changes in quality of life indicators (QOL) according to the SF-36 questionnaireTimepoint: from baseline;Changes of the index according to the ACQ-5 questionnaire for evaluation of BA control Timepoint: from baseline.;Evolution of the PEF valueTimepoint: as measured at Visits 2, 3 and 4. | — |
Countries
India, Russian Federation
Contacts
Public ContactDr S Sadgune
Mudra Clincare
Outcome results
None listed