Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2015-03-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Flunisolide HFA
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
Flunisolide HFA
Interventions
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Flunisolide HFA
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
18 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
University of Louisville
OTHER
Responsible Party
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Nemr Eid
Principal investigator
Locations
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University of Louisville Pediatric Pulmonology
Louisville, Kentucky, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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14.1024
Identifier Type: -
Identifier Source: org_study_id