Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma

NCT02577497 | Completed Phase 4 DMC

• 1 other identifier: 18422
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry powder).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Ventilation Heterogeneity Index (VHI)

  VHI = lung defect volume divided by total lung volume. It is a ratio scale.

  Baseline

Secondary Outcomes (1)

• Change in Ventilation Heterogenity Index (VHI)

  Baseline (week 0), week 12, week 16, and week 24

Study Arms (2)

Beclomethasone

EXPERIMENTAL

Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks)

Drug: beclomethasone

fluticasone

EXPERIMENTAL

Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks)

Drug: fluticasone

Interventions

beclomethasone DRUG

Beclomethasone

fluticasone DRUG

fluticasone

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls between the ages of 6 and 17 years
• Diagnosis of asthma based on NAEPP3 criteria
• Poor asthma control based on one or more of the following criteria:
• an ACT ≤ 19 and/or ACQ ≥ 1.5 units at the screening and/or randomization visits despite continuous or intermittent treatment with ICS and/or an anti-leukotriene within six months before enrollment.
• Any airflow obstruction based on Hankinson et al reference standards: FEV1 % \< 80% predicted, an FEV1/FVC ratio \< 90% predicted, and/or an FEF 25-75 \< 70% predicted at the screening and/or randomization visits.
• Frequent severe exacerbations as reflected by ≥ 2 bursts of systemic corticosteroids (≥ 3 days each) in the previous 12 months.
• Serious exacerbations reflected by at least one hospitalization, ICU stay, or mechanical ventilation in the previous 12 months
• "Not well controlled" by NAEPP or GINA asthma treatment guidelines
• For post-pubertal females, negative urine pregnancy screen and willing if sexually active (as counseled by a female study coordinator in private) to using a consistent and appropriate method of birth control for the duration of the study.

You may not qualify if:

• Premature birth \< 35 weeks estimated gestational age
• Maintenance oral prednisone (defined as daily or alternate day for the past three months before screening) or omalizumab treatment for asthma control
• Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in the eye, pacemaker, or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
• Chest circumference greater than that of the helium coil. The circumference of the coil is approximately 42 inches.
• Inability to understand simple instructions or to hold still for 10 seconds.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia - Fontaine Research Park

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Gerald Teague W, Mata J, Qing K, Tustison NJ, Mugler JP, Meyer CH, de Lange EE, Shim YM, Wavell K, Altes TA. Measures of ventilation heterogeneity mapped with hyperpolarized helium-3 MRI demonstrate a T2-high phenotype in asthma. Pediatr Pulmonol. 2021 Jun;56(6):1440-1448. doi: 10.1002/ppul.25303. Epub 2021 Feb 23.

  PMID: 33621442 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Androstadienes; Androstenes; Androstanes

Study Officials

• W. Gerald Teague, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Respiratory Medicine, Allergy, and Immunology

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 16, 2015
• Study Start: June 1, 2016
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

US (1)