NCT02404103

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 20, 2017

Completed
Last Updated

December 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

March 18, 2015

Results QC Date

July 5, 2017

Last Update Submit

December 13, 2017

Conditions

Childhood Asthma

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Flunisolide 160 mcg per day

ACTIVE COMPARATOR

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

Flunisolide 320 mcg per day

ACTIVE COMPARATOR

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

Interventions

Flunisolide HFADRUG
Flunisolide 160 mcg per dayFlunisolide 320 mcg per day

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of asthma
  • Informed consent by parent or legal guardian
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville Pediatric Pulmonology

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

flunisolide

Limitations and Caveats

The small numbers of subjects who qualified and completed the study.

Results Point of Contact

Title
Nemr Eid, MD
Organization
University Louisville
n.eid@louisville.edu
502-852-3772

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 31, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

December 14, 2017

Results First Posted

October 20, 2017

Record last verified: 2017-11

Locations

US(1)