Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Budesonide and formoterol fumarate dihydrate inhalation aerosol: Dose: 80/ 4.5 mcg (2 puffs twice daily). Duration of study for individual subject will be up to 21 days.
Control Interve
Sponsors
Cipla Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects who are 18 – 75 years (both inclusive) of age at the time when informed consent is obtained. 2. Subjects diagnosed with asthma by the investigator in accordance to relevant guidelines i.e. GINA guidelines 2022 for asthma diagnosis and management. 3. Subjects on stable treatment of asthma for at least 2 weeks prior to screening. 4. Patient whose current asthma therapy can be replaced with study therapy as assessed by the investigator. 5. Women of child-bearing potential (WOCBP) must commit to be consistent and for correct use of an acceptable method of birth control (acceptable method will be at the investigator’s discretion) throughout the study.
Exclusion criteria
Exclusion criteria: 1. History of life-threatening asthma that required intubation and/or was associated with hypercapnoea, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year prior to enrolment visit. 2. History of any asthma related hospitalizations within the past one year prior to enrolment visit. 3. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension (systolic BP =160 mm Hg or diastolic BP >100 mm Hg), uncontrolled coronary artery disease, myocardial infarction, Stroke within 3 months prior to the enrolment visit, 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 4. Intercurrent disease or condition that, in the opinion of the Investigator, might compromise the subject’s continued safety or eligibility for the study 5. History of any adverse reaction; known hypersensitivity to corticosteroids, sympathomimetic drugs (e.g., formoterol, albuterol) or any other constituents of the investigational product 6. Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the subjects’ compliance with the study protocol or scheduled clinic visits 7. Women of childbearing potential (WOCBP) who are lactating or pregnant at enrolment visit, as documented by a positive screening pregnancy test (see schedule of study events). For this study, WOCBP is defined as females following menarche until becoming postmenopausal or undergoing permanent sterilization. Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy 8. Study participation by clinical investigator site employees and/or their immediate relatives 9. Use of any investigational drug (approved or unapproved) within 5 half lives or 30 days (whichever is longer) preceding the screening or participated in another investigational drug study at any time during this study 10. Subjects unable to use placebo pMDI correctly after adequate training of inhalation technique and device use as deemed acceptable by investigator 11. Subjects who have had Covid-19, 2 weeks prior to the study and during the study will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Used devices will be sent to the analytical laboratory to measure relevant product in vitro characteristics including dose counter functionality test. Number of used devices will be descriptively summarized and device characteristics data received from external labs will be presented as frequencies and percentage wise. If there are any malfunctioning devices, this will also be summarized by frequency and percentages.Timepoint: There are four different timepoints for collection of information regarding device malfunctioning at enrolment visit (Day 1), Day 6 (Telephone Follow up), Day 12 (Interim Visit), Day 18 (Telephone Follow up) and Day 21 (EOS visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety measures including vital signs, oropharyngeal examination and adverse eventTimepoint: Throughout the study. | — |
Countries
India
Contacts
Public ContactDr Gaurav Mittal
Cipla Ltd
Outcome results
None listed