Childhood AsthmaNCT02404103

Flunisolide HFA in Children With Small Airway Disease

A study testing Flunisolide HFA in people with Childhood Asthma, run by University of Louisville at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Childhood Asthma
What is being tested?: Flunisolide HFA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Louisville Pediatric Pulmonology
Louisville, Kentucky, 40202

Other trials in United States

About this study

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.

Read the 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.

Conditions: Childhood Asthma
Being tested: Flunisolide HFA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flunisolide HFADrug

Study groups in NCT02404103
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Flunisolide HFA

What is being measured

The primary outcome is the main question the study is designed to answer.

Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide
the most used outcome in respiratory studies
Measured: 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.
Measured: Baseline and six week followup
Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)
Indirectly assess small airway function.
Measured: 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.
Measured: initial visit and six week followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Jun 2017

First posted31 Mar 2015 (estimated)
Study startMar 2015
Primary completionMay 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Childhood AsthmaStudies of the same condition, open and under way.
More trials run by University of LouisvilleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02404103
Sponsor's protocol ID: 14.1024
Status last verified: Nov 2017
First submitted: 18 Mar 2015
Last updated: 14 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Flunisolide HFA in Children With Small Airway Disease
ClinicalTrials.gov ID: NCT02404103
Acronym / sponsor ID: 14.1024
Conditions: Childhood Asthma
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of LouisvilleUniversity, hospital or other
Collaborators: Meda Pharmaceuticals
Study start: Mar 2015
Primary completion: May 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 31 Mar 2015 (estimated)
Results: Posted 20 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Flunisolide 160 mcg per day	Active comparator	Drug: Flunisolide HFAPatients 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 320 mcg per day	Active comparator	Drug: Flunisolide HFAPatients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flunisolide HFA	Drug	Flunisolide 160 mcg per day, Flunisolide 320 mcg per day

Primary outcome

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

Results and safety

Results posted to the registry on 20 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flunisolide 160 mcg Per Day	14	10
Flunisolide 320 mcg Per Day	12	9

Primary outcome: Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide

Time frame: Before and after treatment at baseline and six week followup. Mean (Standard Deviation). Unit: % of predicted

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n = 10	Flunisolide 320 mcg Per Day Pretreatment - Baseline n = 9	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n = 10	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n = 9
Value	80.4 (10.8)	78.7 (9.0)	85.0 (10.3)	77.0 (7.6)

Flunisolide 160 mcg Per Day Posttreatment - 6 Wks vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = .148, Mixed Models Analysis
Flunisolide 160 mcg Per Day Pretreatment - Baseline vs Flunisolide 160 mcg Per Day Posttreatment - 6 Wks: p = .740, Mixed Models Analysis
Flunisolide 320 mcg Per Day Pretreatment - Baseline vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = .921, Mixed Models Analysis

Population analysed: Those subjects that completed the study protocol.

Primary outcome: Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment

Time frame: Baseline and six week followup. Mean (Standard Deviation). Unit: cmH2O/L

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n = 10	Flunisolide 320 mcg Per Day Pretreatment - Baseline n = 9	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n = 10	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n = 9
Value	17.4 (12.3)	13.9 (16.6)	18.5 (9.6)	14.9 (13.5)

Flunisolide 160 mcg Per Day Pretreatment - Baseline vs Flunisolide 160 mcg Per Day Posttreatment - 6 Wks: p = .872, Mixed Models Analysis
Flunisolide 160 mcg Per Day Posttreatment - 6 Wks vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = 0.820, Mixed Models Analysis
Flunisolide 320 mcg Per Day Pretreatment - Baseline vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = 0.582, Mixed Models Analysis

Population analysed: Those subjects that completed the study protocol.

Primary outcome: Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)

Time frame: baseline and six week followup. Mean (Standard Deviation). Unit: % of predicted

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n = 10	Flunisolide 320 mcg Per Day Pretreatment - Baseline n = 9	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n = 10	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n = 9
Value	60.3 (20.0)	61.5 (13.7)	57.7 (12.1)	65.2 (18.9)

Flunisolide 160 mcg Per Day Pretreatment - Baseline vs Flunisolide 160 mcg Per Day Posttreatment - 6 Wks: p = .782, Mixed Models Analysis
Flunisolide 160 mcg Per Day Posttreatment - 6 Wks vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = .906, Mixed Models Analysis
Flunisolide 320 mcg Per Day Pretreatment - Baseline vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = .102, Mixed Models Analysis

Population analysed: Those subjects that completed the study protocol.

Primary outcome: Impulse Oscillometry (IOS) Resistance 5 (R5)

Time frame: initial visit and six week followup. Mean (Standard Deviation). Unit: cmH2O(L/s)

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n = 10	Flunisolide 320 mcg Per Day Pretreatment - Baseline n = 9	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n = 10	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n = 9
Value	6.5 (2.0)	5.8 (2.3)	7.0 (1.4)	6.0 (1.8)

Flunisolide 160 mcg Per Day Pretreatment - Baseline vs Flunisolide 160 mcg Per Day Posttreatment - 6 Wks: p = .620, Mixed Models Analysis
Flunisolide 160 mcg Per Day Posttreatment - 6 Wks vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = .543, Mixed Models Analysis
Flunisolide 320 mcg Per Day Pretreatment - Baseline vs Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks: p = .6, Mixed Models Analysis

Population analysed: Only data for subjects who completed study are presented.

Adverse events

Time frame: up to 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flunisolide 160 mcg Per Day	1 of 10 (10%)	0 of 10 (0%)	0 of 10
Flunisolide 320 mcg Per Day	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): The small numbers of subjects who qualified and completed the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Childhood Asthma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flunisolide HFA in people with Childhood Asthma, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide (time frame: Before and after treatment at baseline and six week followup). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02404103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.