Rhinitis, Allergic, PerennialPhase 3NCT00103454
A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).
A Phase 3 study testing GW685698X in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 49 sites in 2 countries.
Trial summary
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- GW685698X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Jan 2005to May 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
Who cannot join
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy medications and some other medications during the study.
- Current tobacco use.
- Clinically significant abnormal ECG or laboratory abnormality.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States43 sites
GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Lilburn, Georgia, 30047
GSK Investigational Site
Lincoln, Nebraska, 68505
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
New Braunfels, Texas, 78130
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, 73104
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Portland, Maine, 04102
GSK Investigational Site
Providence, Rhode Island, 02906
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rockville, Maryland, 20850
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
St Louis, Missouri, 63104
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Summit, New Jersey, 07091
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Vero Beach, Florida, 32960
GSK Investigational Site
West Allis, Wisconsin, 53227
Canada6 sites
GSK Investigational Site
Kelowna, British Columbia, V1Y 9L8
GSK Investigational Site
Mississauga, Ontario, L5A 1N1
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2
GSK Investigational Site
Québec, Quebec, G1V 4M6
GSK Investigational Site
Saskatoon, Saskatchewan, S7H 0V1
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E1
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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Read the detailed description
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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- GW685698X
- Keywords
- allergic rhinitis, GW685698X, Perennial Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698XDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: GW685698X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
Secondary outcomes (1)
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2005 (estimated)
- Study startJan 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Who is masked
- Participant, Investigator
- Enrolment
- 288 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
- NCT00103454
- Sponsor's protocol ID
- FFR30002
- Status last verified
- Sep 2016
- First submitted
- 8 Feb 2005
- Last updated
- 19 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes
Publications
Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy
Nathan RA, Berger W, Yang W, Cheema A, Silvey M, Wu W, Philpot E. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008 May;100(5):497-505. doi: 10.1016/S1081-1206(10)60477-2.
PubMed 18517084
Study at a glance
From the registry record, last updated by the sponsor on 19 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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
- ClinicalTrials.gov ID
- NCT00103454
- Acronym / sponsor ID
- FFR30002
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- allergic rhinitis, GW685698X, Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 9 Feb 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 primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Detailed description
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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: GW685698X |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
Key exclusion criteria (5 listed)
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy medications and some other medications during the study.
- Current tobacco use.
- Clinically significant 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 | Arm 1 |
Primary outcome
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
1 secondary outcome
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
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 Sep 2016.
- Results publicationNathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy
- Derived from this study: PubMed 18517084Nathan RA, Berger W, Yang W, Cheema A, Silvey M, Wu W, Philpot E. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008 May;100(5):497-505. doi: 10.1016/S1081-1206(10)60477-2.
- 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
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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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
49 sites in 2 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 49 sites in 2 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 2 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 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 49 sites in United States, Canada. 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?
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.. 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 NCT00103454, which also lists 2 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 Sep 2016.