A Single-dose, Open-label, Randomized, Incomplete Block Design Trial to Characterize the Pharmacokinetics of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System and Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Pediatric Subjects Aged 4 to 8 Years With Wheezing, Reactive Airway Disease or Mild Asthma
Phase: PHASE1
Conditions: Wheezing, Reactive Airway Disease, Mild Asthma
Sponsor: Vectura Limited

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Nonclinical Data 
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Clinical Data 
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1.5
Summary of Known and Potential Risks and Benefits 
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Route of Administration, Dosage, Dosage Regimen and Treatment Period(s) 
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Table 2: 
Predicted doses delivered for VR647 inhalation suspension 
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1.7
Population to be Studied 
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Compliance Statement 
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OBJECTIVES 
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Primary Objective 
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TRIAL DESIGN 
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Overall Trial Design and Plan 
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Trial Endpoints 
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3.2.2 Secondary Endpoints 
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Randomization 
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Blinding 
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3.5
Trial Duration 
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Criteria for Stopping the Trial 
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Definition of End of Trial 
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4
TRIAL POPULATION 
4.1
Number of Subjects 
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Inclusion Criteria 
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Exclusion Criteria 
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4.4
Withdrawal of Subjects from the Trial 
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Replacement of Subjects 
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5
TREATMENT OF SUBJECTS 
5.1
Description of Investigational Medicinal Product(s) 
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Supply, Packaging, Labelling and Storage 
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5.3
Accountability Records 
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5.4
Concomitant Medication and Dietary Supplements 
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Procedures for Monitoring Subject Compliance 
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Life Style Restrictions 
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TRIAL PROCEDURES 
6.1
Schedule of Assessments 
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Trial Visits and Procedures 
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6.2.1 Visit 1 (Day -32 to Day -2): Screening 
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6.2.2 Visit 2 (Day -1 to Day 1): Treatment Period 1 
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6.2.2.1 Pre-Dosing Procedures 
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6.2.3 Visit 3 (Day 7±3 Days to Day 8±3 Days): Treatment Period 2 
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6.2.4 Visit 4 (Day 15±3 Days): Followup Assessment 
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6.2.5 Early Withdrawal Visit 
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Total Blood Volume 
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ASSESSMENT OF EFFICACY 
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Modified Patient Satisfaction and Preference Questionnaire 
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ASSESSMENT OF SAFETY AND TOLERABILITY 
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8.1
Medical and Surgical History 
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Vital Signs 
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8.3
Physical Examination 
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Body Weight and Height 
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PHARMACOKINETIC ASSESSMENTS 
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Pharmacokinetic Procedures 
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STATISTICAL CONSIDERATIONS 
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Analysis Sets 
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QUALITY CONTROL AND QUALITY ASSURANCE 
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Monitoring 
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Audits and Inspections 
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REGULATORY AND ETHICAL CONSIDERATIONS 
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Protocol Amendments 
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