Study to Test the Product Robustness of a Dry Powder Inhalation Device When Used in Normal Clinical Practice with Young Asthma Patients

Phase 1

Conditions: The study is designed to demonstrate the robustness of the OT329 Solisproduct. The primary endpoint that is derived from the dataset will beproduct robustness after approximately 21-24 days of patient use asdetermined by:• Emitted dose,• Aerodynmic article size distribution,• Visual inspection for damage or evidence of tampering,• Mechanical performance
MedDRA version: 17.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1Level: LLTClassification code 10003561Term: Asthma, unspecifiedSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2014-001089-90-GB

Lead Sponsor: Oriel Therapeutics, a Sandoz Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

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

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)