| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| The medical condition which is under investigation is Asthma. |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10038738 |
| E.1.2 | Term | Respiratory, thoracic and mediastinal disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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
|
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| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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.
|
|
| E.4 | Principal 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.
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| E.5 End points |
| E.5.1 | 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.
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 1 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Definition of the end of trial is the last patient last visit. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
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