Health Condition 1: J453- Mild persistent asthma
Conditions
Interventions
Intervention1: Albuterol sulfate inhalation aerosol (90 mcg Base/Inh): Test Product (T): Albuterol sulfate inhalation aerosol (90 mcg Base/Inh) - Duration 1 day in any one of the four periods (period
Sponsors
MACLEODS PHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-dose PD20 which is a provocative dose (PD) of methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of Albuterol or Placebo inhalation o The 20% reduction in FEV1 is determined relative to saline FEV1 measured before the Placebo or Albuterol administrationTimepoint: Post dose at Period 1, 2, 3, and 4 (Time frame: 15-min after last inhalation of study treatment] | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-dose PC20 which is a provocative concentration (PC) of methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of Albuterol or Placebo inhalationTimepoint: Post dose at Period 1, 2, 3, and 4 a total of approximately 4 weeks. | — |
Countries
India
Contacts
Public ContactDr Ashish Mungantiwar
Macleods Pharmaceuticals Ltd
Outcome results
None listed