AsthmaPhase 1NCT00370097
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
A Phase 1 study testing FLOVENT (fluticasone propionate) HFA in people with Asthma, run by GlaxoSmithKline at 7 sites in United States.
Trial summary
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Asthma
- What is being tested?
- FLOVENT (fluticasone propionate) HFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Aug 2006to 12 Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
- Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
- Parents/guardians should be able to read and comprehend diary information collected throughout the study
- Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
Who cannot join
- Subjects who weigh less than 7 kg
- Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
- Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
GSK Investigational Site
Atlanta, Georgia, 30309-7520
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jacksonville, Florida, 32207
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
About this study
Official title: PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
Read the detailed description
A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months
- Conditions
- Asthma
- Being tested
- FLOVENT (fluticasone propionate) HFA, Placebo HFA
- Keywords
- Asthma infants FLOVENT spacer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOVENT (fluticasone propionate) HFADrug
FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.
Placebo HFADrug
Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving HFA | Experimental | Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily Receives: Drug: FLOVENT (fluticasone propionate) HFA; Drug: Placebo HFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cortisol weighted mean(0-12h)
Measured: throughout the study
Secondary outcomes (1)
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study start30 Aug 2006
- Primary completion12 Apr 2007
- Study completion12 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370097
- Sponsor's protocol ID
- FAS106533
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2006
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
- ClinicalTrials.gov ID
- NCT00370097
- Acronym / sponsor ID
- FAS106533
- Conditions
- Asthma
- Keywords
- Asthma infants FLOVENT spacer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2006 (actual)
- Primary completion
- 12 Apr 2007 (actual)
- Study completion
- 12 Apr 2007 (actual)
- First posted
- 30 Aug 2006 (estimated)
- Results
- Not posted in the source record
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 address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
Detailed description
A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving HFA | Experimental | Drug: FLOVENT (fluticasone propionate) HFA, Drug: Placebo HFASubjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
- Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
- Parents/guardians should be able to read and comprehend diary information collected throughout the study
- Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
Key exclusion criteria (3 listed)
- Subjects who weigh less than 7 kg
- Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
- Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
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 |
|---|---|---|
| FLOVENT (fluticasone propionate) HFAFLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask. | Drug | Subjects receiving HFA |
| Placebo HFASubjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask. | Drug | Subjects receiving HFA |
Primary outcome
Serum cortisol weighted mean(0-12h)
Time frame: throughout the study
1 secondary outcome
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study FAS106533 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FLOVENT (fluticasone propionate) HFA in people with Asthma, run by GlaxoSmithKline at 7 sites 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 4 inclusion and 3 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum cortisol weighted mean(0-12h) (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2017.