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Clinical Trial Summary

The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a nebulizer, the VR647 Inhalation System. Secondary objectives include the evaluation of the safety and tolerability of VR647 Inhalation Suspension administered using the VR647 Inhalation System.

Clinical Trial Description

The study consists of four visits; a screening visit (Visit 1), two dosing days (Visits 2 and 3) and a follow-up visit (Visit 4). On each dosing day a single dose of treatment will be administered. Blood samples will be collected on eight occasions from pre-dose up to 8 hours post-dose at each dosing visit. Treatment allocation at Visits 2 and 3 is determined by a balanced incomplete block design.

The screening period (including Visit 1) is between 2 and 30 days duration; there is a washout period of 4 to 10 days between each dose (Visits 2 and 3) and the follow-up safety assessment (Visit 4) will occur 5 to 9 days after Visit 3. Subjects and their parent(s)/legal guardian(s) have the option of an overnight stay the day before dosing (Day -1, Visit 2 and Day 7, Visit 3). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03421730
Study type Interventional
Source Vectura Limited
Status Completed
Phase Phase 1
Start date December 18, 2017
Completion date March 27, 2018

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