Assess fluticasone propionate/salmeterol 100/50 mcg dry powder inhaler device functionality after repeated asthma patient use.
- Conditions
- Health Condition 1: J45- Asthma
- Registration Number
- CTRI/2019/08/020752
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. All subjects must sign and date an informed consent form prior to participation in the study.
2. Adult subjects aged 18 to 80 years (both inclusive).
3. Subjects who are on treatment equivalent to low dose inhaled corticosteroids + long acting beta agonist (e.g. 100/50 fluticasone propionate/salmeterol)
4. Subjects who can immediately replace their existing treatment with the study provided drug product as assessed by investigator.
Note: Any drug product other than the similar class of molecule (inhaled corticosteroids + long acting beta agonist) will be continued to be used by the subjects as per the discretion of investigator.
5. Pre-bronchodilator forced expiratory volume in one sec (FEV1) of >=40% of the predicted normal value at screening.
6. Physician diagnosis of asthma for at least 2 weeks prior to screening.
7. Subjects who can use DPI adequately as per investigatorâ??s discretion.
8. Ability and willingness to participate in the study.
1. History of life-threatening asthma defined as an asthma episode(s) 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 screening visit.
2. History of any asthma related hospitalizations within the past one year prior to screening visit.
3. Any asthma exacerbation requiring emergency room visits or systemic corticosteroids within 1 month prior to screening visit.
4. 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 screening 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.
5. Any pulmonary disorder other than asthma, including but not limited to: diagnosis of interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, pulmonary carcinoma, Current evidence of bronchopulmonary dysplasia or pulmonary fibrosis, In addition, obstructive sleep apnea warranting a prescription for continuous or biphasic positive airway pressure (CPAP or BiPAP), regardless of subject compliance with this prescription.
6. History of any adverse reaction; known hypersensitivity to any sympathomimetic drug (e.g., formoterol, albuterol or salmeterol) or any inhaled, or therapy or any other constituents of the investigational product.
7. Subjects who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded.
8. 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.
9. Women of childbearing potential (WOCBP) who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test. 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.
10. Women of childbearing potential unwilling to employ effective contraceptive methods or if they are of non-childbearing potential as defined below:
ï? Methods of contraception include:
i Total abstinence (periodic abstinence and withdrawal are not acceptable contraceptive methods)
ii Surgical sterilization (tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 weeks before screening
iii Vasectomized male (done at least 6 months prior to screening) should be the sole partner for the female patient
iv Congenital sterility
v Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for e.g. vaginal ring, injectable progesterone or transdermal pat
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 testing laboratory of Sitec Labs Pvt. Ltd. (India) to measure relevant product characteristics as pre-defined in separately prepared CMC protocol. Device (dose counter) functionality will also be assessed as described in the CMC protocol malfunctioned devices will also be collected and investigated as per the applicable SOPs of Cipla Ltd.Timepoint: End of study visit (EOS) will be scheduled on day of completion of study treatment
- Secondary Outcome Measures
Name Time Method Secondary outcome measures <br/ ><br>ï?· Adverse events (AEs) <br/ ><br>ï?· Vital signs <br/ ><br>ï?· Oropharyngeal examinationTimepoint: End of study visit (EOS) will be scheduled on day of completion of study treatment