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 MedDRA version: 17.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ C
Conditions
Interventions
Product Name: Oriel OT329 Solis 250/50
Pharmaceutical Form: Inhalation powder
CAS Number: 80474-14-2
Other descriptive name: FLUTICASONE PROPIONATE
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
Oriel Therapeutics, a Sandoz Company
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) no 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: 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)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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™.;Secondary Objective: not applicable;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.;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. | — |
Countries
United Kingdom
Contacts
Public ContactDirector, Clinical Operations
Oriel Therapeutics, a Sandoz Company
Outcome results
None listed