Pilot Study to Demonstrate the Pharmacodynamicequivalence of Albuterol Sulfate Inhalation Aerosol EQ 90 mcg Base/Inh(of Macleods Pharmaceuticals Ltd.)inAdult Patients with Stable Mild Asthma.
- Conditions
- Health Condition 1: J453- Mild persistent asthma
- Registration Number
- CTRI/2021/10/037214
- Lead Sponsor
- MACLEODS PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant, non-lactating female aged between 18 to 65 years (both inclusive)
2. Stable mild asthmatics based on National Asthma Education and Prevention Program
(NAEPP) guidelines
3. Forced expiratory volume in one second (FEV1) more than or equal to 80% of predicted
4. Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline)
PC20 less than or equal to 8 mg/mL
5. Non-smokers for at least six months prior to study and a maximum smoking history of
five-pack years (the equivalent of one pack per day for five years)
6. Able to demonstrate correct use of the pressurized metered dose inhaler using the training
kit provided
7. Must be able to perform acceptable and repeatable spirometry as per American Thoracic
Society (ATS) guidelines
8. Able to provide written informed consent and willing to comply with all aspects of the
trial
1. Known intolerance or hypersensitivity to active or inactive ingredient of the
investigational products or saline or methacholine chloride
2. Evidence of upper or lower respiratory tract infection, e.g. pneumonia, bronchitis,
sinusitis, within six weeks prior to study
3. History of seasonal asthma exacerbation in which case the subject should be studied
outside of relevant allergen season
4. History of cystic fibrosis, bronchiectasis or other respiratory diseases
5. History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease
6. Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months
7. History of severe exacerbation in the last one year prior to screening and mild to
moderate exacerbations in the last 6 weeks prior to screening
8. Inability to tolerate or unwillingness to comply with required washout periods or unable
to temporarily withdraw applicable asthma-medications and/or follow life-style
restrictions (e.g. restriction of xanthine containing foods and beverages) prior to screening and each study period
9. Abnormal prolongation of QT/QTc-interval (males: >430 ms and females: >450 ms)
and/or any other clinically significant electrocardiogram (ECG) abnormalities which in
the opinion of the investigator may affect subjectâ??s safety during the study or interfere
with the study results
10. Serum potassium levels and random blood sugar levels outside the range (serum
potassium range: 3.7 to 5.2 mEq/L; random blood sugar range: 80 to 140 mg/dL) and
hemoglobin A1c (HbA1c) more than 8%
11. Males or females planning pregnancy during the study duration
12. Males or females of childbearing potential not willing to use adequate and consistent
contraception methods during the study period
13. Positive serology test results at screening for human immunodeficiency virus (HIV) I and
HIV II, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening
14. Subjects who have been treated in a clinical trial with an investigational drug or
investigational device within a period of 90 days prior to screening
15. Any clinically significant acute or chronic illness that could compromise the integrity of
study data or affect the analyses if the disease exacerbates during the study or place the subject at risk by participating in the study
16. Any elective, pre-planned or scheduled surgery or hospitalizations prior to start of the study
17. Subjects with history of surgery within six weeks prior to screening, which in the opinion
of the investigator interferes with study treatment results or affects the safety of the
subject during the study
18. Known history of drug/substance abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method