A Randomised, Open-Label, Active-Controlled, Two-Period Crossover Study to Evaluate Relative Efficacy and Safety of Investigational Captisol-Enabled® Budesonide Inhalation Solution (CBIS) Delivered via eFlow® Nebuliser and Conventional Budesonide Inhalation Suspension (Pulmicort Respules®) Delivered via LC Plus® Jet Nebuliser in Children with Mild-to-Moderate Persistent Asthma

Phase 1

• Conditions: Asthma; MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-003801-21-GB
• Lead Sponsor: Verus Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Male or female paediatric subjects who are steroid-requiring or steroid-free will be eligible for the study if they meet all of the following inclusion criteria:
1.Age 5 to 12 years, inclusive, at the Screening Visit. Note: Females, who may be of childbearing potential (menses have started), will have a urine pregnancy test at the beginning of the study
2.History of asthma for greater than or equal to 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms.
3.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be less than or equal to 500 mcg/day beclomethasone dipropionate or equivalent.
4.History of FEV1 of > 60% of predicted normal values following appropriate withholding of inhaled beta-agonist and corticosteroid medication.
5. Negative pregnancy test (if of child bearing age)
6.Must otherwise be healthy as judged by general physical examination, medical history and routine clinical laboratory screening.
7.Provide written informed consent (parent or legal guardian) and, as appropriate, subject assent.
8.Willing and able to attend scheduled visits and complete the entire study.
9.Subjects on inhaled budesonide medication, must be willing to discontinue or replace current treatment.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Paediatric subjects will not be eligible for the study if they meet any of the following exclusion criteria:
1.History of life-threatening asthma, as defined in the GSAMP. This category includes those paediatric subjects with a history of near-fatal asthma requiring intubation or a hospitalisation or an Urgent Care Facility visit for asthma in the past year.
2.Current evidence or history of any clinically significant disease or abnormality. Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
3.History of concomitant lung disease.
4.An upper or lower respiratory tract infection within 4 weeks prior to the Screening Visit.
5.Current evidence of oral candidiasis.
6.Current evidence or history of hypersensitivity or idiosyncratic reaction to inhaled budesonide.
7.Receipt of an investigational drug within 30 days of the Screening Visit.
8.Use of more than 12 puffs of Salbutamol per day.

Study & Design

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