In:vitro assessment of device/inhaler after repeated patient use

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male or female subjects who are 18 â?? 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 for asthma diagnosis and management

3.Subjects on stable treatment of asthma for atleast 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 investigatorâ??s discretion) throughout the study

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 subjectâ??s continued safety or eligibility for the study

5.History of any adverse reaction; known hypersensitivity to corticosteroids or any other constituents of the investigational product

6.Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the subjectsâ?? 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.Treatment with any other study medication in a clinical trial in the last 3 months before signing an informed consent form

10.Subjects unable to use pMDI device with or without spacer or comply with the study regimen

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The used devices will be collected from the subjects and sent to the central testing laboratory of Sitec Labs Pvt. Ltd. (India) to measure relevant product characteristics as pre-defined in CMC protocol prepared separately. Device (dose counter) functionality will also be assessed as described in the CMC protocol. Malfunctioned devices will also be collected and returned for regulatory purpose.Timepoint: End of study visit (EOS) will be scheduled on day of completion of 24 days of study treatment or on Day 40

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)Timepoint: End of study visit (EOS) will be scheduled on day of completion of 24 days of study treatment or on Day 40

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