E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study is designed to demonstrate the robustness of the OT329 Solis
product. The primary endpoint that is derived from the dataset will be
product robustness after approximately 21-24 days of patient use as
determined by:
• Emitted dose,
• Aerodynmic article size distribution,
• Visual inspection for damage or evidence of tampering,
• Mechanical performance |
|
E.1.1.1 | Medical condition in easily understood language |
The study is designed to demonstrate the robustness of the OT329 Solis
product in young patients 4-18 years old.
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|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038738 |
E.1.2 | Term | Respiratory, thoracic and mediastinal disorders |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003561 |
E.1.2 | Term | Asthma, unspecified |
E.1.2 | System Organ Class | 10038738 - 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 |
To observe the function of devices after 21-24 days of normal use by
patients as measured by in vitro tests of the OT329 Solis™. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females between 10 and 18 years old.
2. Subjects with a clinical history of asthma who are presently prescribed Seretide™ Accuhaler™ 100/50,
250/50 or equivalent Seretide MDI dose.
3. Subjects who regularly use daily Seretide™ Accuhaler™ (or equivalent).
4. Subjects, and their legal representative if a minor, who are able and willing to give written informed
consent. |
|
E.4 | Principal exclusion criteria |
1. Subjects who have a clinically relevant history or presence of gastrointestinal, renal, hepatic,
haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders which would preclude participation in the opinion of the Investigator.
2. Females subjects who are pregnant or breasfeeding
3. Subjects who have used any investigational drug in any clinical trial within 1 month of receiving the first dose of OT329 Solis™ study medication.
4. Subjects who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator.
5. Subjects with a milk protein allergy. (note: lactose intolerance is not considered a milk allergy, patients with lactose intolerance are eligible)
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E.5 End points |
E.5.1 | Primary end point(s) |
Devices will be collected after 21-24 days of use and will be shipped to a testing facility where the following
in vitro assessments will be made:
- emitted dose
- aerodynamic particle size distribution
- visual inspection for damage or evidence of tampering,
- mechanical performance, and
Further, any device found to not function properly or have apparent damage will be investigated to determine the cause. The exact sampling is detailed in a separate In Vitro Testing Plan.
The monitoring and recording of adverse events will be the primary safety assessment reported. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The timepoint of evaluation is at the end of study which is expected to
occur within 21-24 days after first usage of the test article. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To test the robustness of a dry powder inhaler OT329 Solis
250/50 and OT329 Solis 100/50 when used in normal clinical practice |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Product Robustness when used in normal clinical practice |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |