Rhinitis, Allergic, PerennialPhase 3NCT00107757
Seasonal Allergic Rhinitis In Pediatric Subjects
A Phase 3 study testing GW685698X in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 65 sites in United States.
Trial summary
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- GW685698X
- How many people
- 576 participants
- Where
- 65 sitesUnited States
- Study dates
- Mar 2005to Nov 2005
- Phase
- Phase 3
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of seasonal allergic rhinitis.
- Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.
Who cannot join
- Have significant concomitant medical conditions.
- Use of corticosteroids, other allergy meds during the study.
- Have abnormal ECG or laboratory abnormality.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
GSK Investigational Site
Altoona, Pennsylvania, 16601
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Brockton, Massachusetts, 02301
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Costa Mesa, California, 92626
GSK Investigational Site
Cranberry Township, Pennsylvania, 16066
GSK Investigational Site
Cudahy, California, 90201
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Fort Collins, Colorado, 80526
GSK Investigational Site
Gainesville, Georgia, 30501
GSK Investigational Site
Greenfield, Wisconsin, 53228
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Knoxville, Tennessee, 37922
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Lakewood, Colorado, 80401
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Lilburn, Georgia, 30047
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Mineola, New York, 11501
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
North Andover, Massachusetts, 01845
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Ocean City, New Jersey, 07712
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Richland, Michigan, 49083
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
Shreveport, Louisiana, 71105
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Utica, New York, 13502
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Warrensburg, Missouri, 64093
GSK Investigational Site
Woodstock, Georgia, 30188
GSK Investigational Site
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- GW685698X
- Keywords
- pediatric, Seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698XDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.
Secondary outcomes (1)
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2005 (estimated)
- Study startMar 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 576 participants
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
- NCT00107757
- Sponsor's protocol ID
- FFR100010
- Status last verified
- Sep 2016
- First submitted
- 7 Apr 2005
- Last updated
- 15 Sep 2016
- Results posted
- 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 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT00107757
- Acronym / sponsor ID
- FFR100010
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- pediatric, Seasonal allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 8 Apr 2005 (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 determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of seasonal allergic rhinitis.
- Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.
Key exclusion criteria (3 listed)
- Have significant concomitant medical conditions.
- Use of corticosteroids, other allergy meds during the study.
- Have abnormal ECG or laboratory abnormality.
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 |
|---|---|---|
| GW685698X | Drug | – |
Primary outcome
Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.
1 secondary outcome
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.
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 15 Sep 2016.
- 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.
- 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.
Related trials for Rhinitis, Allergic, Perennial
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Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
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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
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW685698X in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 65 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 2 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.. 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 15 Sep 2016.