The medical condition which is under investigation is Asthma. MedDRA version: 9.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Albuterol
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: Albuterol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.63-
Produ
Sponsors
Verus Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be eligible for the study if they meet all of the following inclusion criteria: 1. Age 18 to 45 years, inclusive, at the Screening Visit. 2. History of asthma for at least 12 months prior to the Screening Visit (“asthma” as defined by the Global Initiative for Asthma [GINA].) 5 3. Demonstrate an FEV1 of =60% of predicted normal values at the Screening Visit. 4. Demonstrate a minimum of 15% improvement in FEV1 in response to two actuations of salbutamol pMDI inhalation. 5. Must be otherwise healthy as judged by general physical examination, medical history and routine clinical laboratory screening. 6. If female and of childbearing potential, must have a negative pregnancy test at the Screening Visit, and must be using one of the following acceptable means of birth control throughout the study: a. Abstinence; b. Post-menopausal for at least two years; c. Surgically sterile; d. Oral contraceptives (taken for at least one month prior to the Screening Visit); e. Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent); f. Barrier methods (e.g., condoms with spermicide); g. Intrauterine device (i.e., IUD); h. Vasectomy of male partner; i. Non-heterosexual life style. 7. Able and willing to provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for the study if they meet any of the following exclusion criteria: 1. Asthma exacerbation requiring emergency care visit, inpatient hospitalization or systemic corticosteroids within four weeks prior to the Screening Visit. 2. Diagnosed with only exercise-induced bronchospasm; 3. Current evidence or history of any clinically significant disease or abnormality. “Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study. 4. History of non-reversible pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis). 5. Upper or lower respiratory tract infection within four weeks prior to the Screening Visit. 6. Current smoker or history of smoking equivalent to 10-pack years. 7. Current evidence or history of hypersensitivity or paradoxical bronchospasm to sympathomimetic medications. 8. Receipt of an investigational new drug within 30 days of the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of the trial are: • To quantify intra-pulmonary deposition of salbutamol by gamma scintigraphy • To determine the systemic bioavailability of salbutamol by plasma sampling • To determine the efficacy of AIS as demonstrated by pulmonary function tests (PFTs) • To determine the safety and tolerability of AIS ;Secondary Objective: none;Primary end point(s): The primary efficacy (deposition) variable representing pulmonary deposition of radiolabelled salbutamol preparations will be expressed in terms of % loaded and emitted dose following appropriate corrections for radioactive decay and tissue attenuation. The emitted dose is defined as the radioactivity exiting the inhaler mouthpiece and subsequently detected in the lungs and oropharynx (including mouthwashings and stomach deposition) and on the exhalation filter if applicable. Radioactivity detected in the lungs and oropharynx (including mouthwashings and stomach deposition) and on the exhalation filter, if applicable, will be corrected for such factors as decay and tissue attenuation, and will be expressed as a percent of the sum of recovered activity. The loaded dose is defined as the radioactivity aliquoted into the inhaler reservoir/dose chamber, this will be quantified using the gamma camera prior to dosing. Following dosing radioactivity detected in the lungs and oropharynx (including mouthwashings and stomach deposition) and on the exhalation filter (if applicable) will be corrected for decay, tissue attenuation etc., and will be expressed as a percent of the activity in the device prior to dosing. | — |
Countries
United Kingdom
Outcome results
None listed