Flunisolide HFA in Children With Small Airway Disease

The purpose of this study is to see how two doses of Flunisolide HFA (an FDA approved inhaled medication to treat asthma) affect the small airways in children with asthma.

Study Overview

• Status: Completed
• Conditions: Childhood Asthma
• Intervention / Treatment: Drug: Flunisolide HFA

Detailed Description

This is a prospective, randomized, parallel, open label study. The primary aim is to compare the average change in spirometric values (Forced expiratory volume 1 (FEV1) and Forced Expiratory Flow 25-75% (FEF 25-75%) and Impulse Oscillometry System (IOS) values (Resistance at 5 Hz (R5), Resistance at 20 Hz (R20), Area of reactance (AX), Resonant frequency (Fres)) from baseline to week 6 from participants randomized flunisolide hydrofluoroalkane (HFA) 1 inhalation BID and to flunisolide HFA 2 inhalations BID. The change in scores from baseline to six week follow up will initially be compared using paired t-tests and Chi-squared tests for trend. Repeated measurements will be analyzed using generalized linear mixed-effects regression modeling (GLMM) techniques. For continuous outcomes (e.g. FEV1, FEF 25-75%, Fres, reactance at 5 Hz (X5), AX, R5-R20). The identity link function and normal distribution will be used. For count data (e.g., use of Beta-agonists, episodes of coughing, episodes of wheezing, etc.) the log link function and the Poisson distribution will be used. If we dichotomize outcomes (e.g., a Beta-agonist was used, coughing occurred, etc.) the logit link function and Bernoulli distribution will be used.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Pediatric Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of asthma
• Informed consent by parent or legal guardian
• 6 years to 18 years of age at screening visit
• ability to comply with medication use, study visits and study procedures as judged by the site investigator
• FEF 25-75% <65% of predicted as a marker for small airway disease

Exclusion Criteria:

• Acute wheezing at screening visit or at Baseline visit
• Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit
• Oxygen saturation <95% at screening visit or at Baseline visit
• Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.
• Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
• Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
• Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days
• Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma
• Potential subjects who are pregnant may not enroll in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flunisolide 160 mcg per day; Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period	Drug: Flunisolide HFA
Active Comparator: Flunisolide 320 mcg per day; Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period	Drug: Flunisolide HFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide	the most used outcome in respiratory studies	Before and after treatment at baseline and six week followup
Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment	A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.	Baseline and six week followup
Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)	Indirectly assess small airway function.	baseline and six week followup
Impulse Oscillometry (IOS) Resistance 5 (R5)	Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.	initial visit and six week followup

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Meda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Anti-Asthmatic Agents; Respiratory System Agents; Flunisolide
• Other Study ID Numbers: 14.1024