A comparative study of Albuterol drug in Asthma patients
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2019/10/021608
- Lead Sponsor
- Deva Holding AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant, non-lactating female subjects (18-65 years of age).
2. Moderate-to-severe asthma subjects based on NAEPP guidelines.
3. FEV1 within 40-70% of the predicted at screening visit.
4. Reversible airway obstruction demonstrated by an improvement of 15% or more in FEV1 30 minutes after inhalation of two puffs
(0.18 mg) of Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol).
5. Nonsmoker for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years) before that.
6. Willing to provide written informed consent to participate in this study.
7. History of asthma since at least last one year.
8. History of stable asthma a month prior to screening.
9. Subject must be able to demonstrate correct use of the metereddose inhaler (MDI) using the Vitalograph Aerosol Inhalation Monitor.
10. Able to comply with all study requirements and procedures.
1. Known intolerance or hypersensitivity to any components of the albuterol MDI.
2. Intolerance to aerosolized β2-adrenergic agonists.
3. Prior treatment with systemic corticosteroids during the last 3months or subjects who are currently taking oral corticosteroids.
4. Use of long-acting β2-agonists in last 2 weeks prior to randomization.
5. Require continuous treatment with monoamine oxidase inhibitors, tricyclic antidepressants or β-blockers (administered by any route).
6. Dosage of any required inhaled corticosteroids, cromolyn and/or
nedocromil are not stable for at least four weeks prior to the screening. Subjects requiring subsequent dosage adjustment of
these drug products during the study will be discontinued from the study.
7. Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the
study.
8. History of life-threatening asthma in the last three years, or ED (Emergency Department) visit or hospitalization for asthma in the
last 12 months.
9. History of frequent exacerbations in the previous year.
10. Subjects whose asthma suspected to have been exclusively seasonal.
11. Other co-morbid respiratory and sinus diseases like tuberculosis, bronchitis, emphysema, COPD.
12. Inability to tolerate or unwillingness to comply with required washout periods or temporary withdrawal for all applicable
medications and xanthine containing foods and beverages prior to screening and each study period.
13. Known or suspected substance abuse (e.g. Alcohol, marijuana, etc.) and /or any other criteria according to the investigator which may affect subjectâ??s safety or study results
14. Inability to tolerate temporary withdrawal of current asthma medication.
15. History of status asthmaticus, cystic fibrosis or bronchiectasis.
16. Abnormal prolongation of QT-interval and/or ECG abnormalities ofclinical relevance.
17. Subjects with abnormal serum potassium value, which is clinically significant as per the opinion of investigator.
18. History of clinically significant cardiovascular, renal, neurologic,
liver or endocrine dysfunction which in the opinion of the investigator, may put the subject at risk because of participation in
the study, or influence the results of the study, or cause concern regarding the subject ability to participate in the study.
19. Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception.
20. Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
21. Subject having night shift work for 1 week prior to screening.
22. Participation in any investigational drug study within 30 days prior to screening.
23. Institutionalized subjects.
24. Any other criteria according to the investigator which may compromise subjectâ??s safety or study results.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline adjusted average area-under-the-effect curve calculated from the zero time to six hours(AUEC0-6h)Timepoint: 7 Weeks
- Secondary Outcome Measures
Name Time Method Baseline adjusted average area-under-the-effect curve calculated from the zero time to four hours (AUEC0-4h). <br/ ><br>Baseline adjusted maximum FEV1 (FEV1max)Timepoint: 7 Weeks