Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 mcg per Actuation: 02 puffs : with interval of 12 hours : 21 days cycle : 42 ± 2 days
Control Intervention1: Symb
Sponsors
Deva Holding AS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects (>= 18 years of age) of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control. 2. Subjects diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP)1, at least 6 months prior to screening. 3. Subjects with moderate-to-severe asthma with a pre-bronchodilator FEV1 of >=45% and 4. Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had 5. Subjects demonstrating >=15% and >=0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI) (Note: Subjects who fail to demonstrate the required reversibility at the Screening Visit (Visit 1) are eligible to enter the Run-in Period and repeat the testing a day before randomization). 6. Subjects must be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment. 7. Subjects must be able to discontinue their asthma medications (inhaled corticosteroids (ICS), leukotriene modifiers (LTM), long-acting β agonists (LABAs), etc.,) during the placebo run-in period and for the remainder of the study. List of prohibited medication during run-in and treatment period is provided in Section 6.5.1. 8. Subjects must be able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits). 9. Subject must be able to demonstrate correct use of the metered-dose inhaler (MDI) using the Vitalograph Aerosol Inhalation Monitor. 10. Willingness to give their written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Institutionalized subjects. 2. History of intolerance to aerosolized β2-adrenergic agonists. 3. Subjects with life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnoea, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period. 4. History of frequent exacerbations in the previous year. 5. Subject has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of baseline visit that, in the investigators opinion, will interfere with the subjects lung function. 6. Subjects with clinical visual evidence of candidiasis at the screening visit, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. 7. Peak expiratory flow must not be below 50% of predicted normal. 8. Subjects with significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.). 9. Subjects with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. 10. Subjects has current clinical evidence of respiratory conditions other than asthma including but not limited to severe nasal polyposis, significant and symptomatic chronic rhinosinusitis,, pneumonia, pneumothorax, atelectasis, bronchiectasis, Churg-Struss Disease, lung resection, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD), sarcoidosis interstitial lung disease, pulmonary tuberculosis. 11. Subjects using prescription or non-prescription medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines, e.g.,: - β-blockers - tricyclic antidepressants - monoamine oxidase inhibitors 12. Subjects who required systemic corticosteroids (for any reason) within the past 4 weeks. 13. Subjects who received a potent CYP3A4 inhibitor within 4 weeks of the screening visit (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). 14. Subjects has clinical significant abnormality in the ECG at the screening visit. 15. Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy. 16. Presence of glaucoma, cataracts, ocular herpes simplex, or current malignancy other than basal cell carcinoma. 17. Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason within 6 months prior to randomization. 18. Inability to tolerate or unwillingness to comply with required washout periods or temporary withdrawal for all applic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on the first day of the treatment. 2. FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of a 6-week treatment. Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events 2. Incidence of asthma exacerbations 3. Incidences of oral and oropharyngeal candidiasis Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactMr Sumit Dodia
Cliantha Research Limited
Outcome results
None listed