Rhinitis, Allergic, PerennialPhase 3NCT00108914
Perennial Allergic Rhinitis Study In Pediatric Subjects
A Phase 3 study testing GW685698X in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 66 sites in 7 countries.
Trial summary
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial 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
- 558 participants
- Where
- 66 sitesin 7 countries
- Study dates
- Feb 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 perennial allergic rhinitis.
Who cannot join
- Have significant concomitant medical conditions.
- Use of corticosteroids or other allergy medications during the study.
- Have abnormal ECG.
- Have laboratory abnormality.
- Have abnormal eye exam.
Trial locations and contacts
66 sites in 7 countries.
66 sites in 7 countries
United States43 sites
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Bellevue, Pennsylvania, 15202
GSK Investigational Site
Brick, New Jersey, 8724
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Costa Mesa, California, 92626
GSK Investigational Site
Cudahy, California, 90201
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Gainesville, Georgia, 30501
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
Lawrenceville, Georgia, 30045
GSK Investigational Site
Liverpool, New York, 13090
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
Rochester, New York, 14627
GSK Investigational Site
Sacramento, California, 95819
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
Shreveport, Louisiana, 71105
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Upland, Pennsylvania, 19013
GSK Investigational Site
Utica, New York, 13502
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Ypsilanti, Michigan, 48197
Italy6 sites
GSK Investigational Site
Bari, 70124
GSK Investigational Site
Milan, 52-20129
GSK Investigational Site
Monticelli Ascoli Piceno, 63100
GSK Investigational Site
Naples, Campania, 80138
GSK Investigational Site
Perugia, 06126
GSK Investigational Site
Salerno, 84100
Argentina4 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ
GSK Investigational Site
Rosario, Santa Fe Province, 2000
GSK Investigational Site
Santa Fe, Santa Fe Province, 3000
Finland4 sites
GSK Investigational Site
Joensuu, 80100
GSK Investigational Site
Nokia, 37100
GSK Investigational Site
Tampere, 33200
GSK Investigational Site
Turku, 20610
Slovakia4 sites
GSK Investigational Site
Banská Bystrica, 974 01
GSK Investigational Site
Bratislava, 821 06
GSK Investigational Site
Levoča, 054 01
GSK Investigational Site
Nitra, 949 01
Mexico3 sites
GSK Investigational Site
México, 04530
GSK Investigational Site
México, 6720
GSK Investigational Site
Monterrey, N.L, 64460
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Viña del Mar, Valparaiso
About this study
Official title: A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- GW685698X
- Keywords
- Perennial allergic rhinitis, pediatric
- Medical subject headings
- Rhinitis, Allergic, Perennial
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 first 4-week treatment period in subjects ages 6 to <12 years.
Secondary outcomes (1)
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period 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 posted21 Apr 2005 (estimated)
- Study startFeb 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 558 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
- NCT00108914
- Sponsor's protocol ID
- FFR30008
- Status last verified
- Jan 2017
- First submitted
- 20 Apr 2005
- Last updated
- 19 Jan 2017
- 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.
Publications
Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).
Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.
Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023.
PubMed 18164990
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00108914
- Acronym / sponsor ID
- FFR30008
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Perennial allergic rhinitis, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 21 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 perennial allergic rhinitis.
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)
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 (1 listed)
- Diagnosis of perennial allergic rhinitis.
Key exclusion criteria (5 listed)
- Have significant concomitant medical conditions.
- Use of corticosteroids or other allergy medications during the study.
- Have abnormal ECG.
- Have laboratory abnormality.
- Have abnormal eye exam.
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 first 4-week treatment period in subjects ages 6 to <12 years.
1 secondary outcome
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period 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 19 Jan 2017.
- Results publicationMáspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).
- Results publicationMáspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.
- Results publication: PubMed 18164990Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023.
- 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.
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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RecruitingObservational study
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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
66 sites in 7 countries: 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 66 sites in 7 countries.
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 1 inclusion and 5 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Italy, Argentina, Finland, Slovakia and 2 more countries. 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 first 4-week treatment period 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?
On the ClinicalTrials.gov record for NCT00108914, which also lists 3 linked publications.
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 19 Jan 2017.