Study to show safety of fluticasone propionate in pre-asthmatic patients aged 6 months to <12 months.

Phase 1

• Conditions: Asthma; MedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-004884-35-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-21
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

- Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
- Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
-Parents/guardians should be able to read and comprehend diary information collected throughout the study
-Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
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

- Subjects who weigh less than 7 kg
- Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
- Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified