Rhinitis, Allergic, SeasonalPhase 3NCT00358475
Study Of Perennial Allergic Rhinitis
A Phase 3 study testing GW685698 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site.
Trial summary
This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- GW685698
- How many people
- 65 participants
- Where
- 1 siteLocation not given
- Study dates
- 21 Jun 2005to 12 Oct 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent.
- Outpatient.
- Diagnosis of perennial allergic rhinitis with symptoms.
- Able to comply with study procedures.
Who cannot join
- Significant concomitant medical condition.
- Use of corticosteroids/allergy medications.
- Laboratory abnormality.
- Positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
Location not given1 site
GSK Investigational Site
About this study
Official title: Study of Perennial Allergic Rhinitis -Long Term Treatment Study-
This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- GW685698
- Keywords
- perennial allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and laboratory blood test
Secondary outcomes (1)
Change of nasal symptom score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study start21 Jun 2005
- Primary completion1 Oct 2005
- Study completion12 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 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
- NCT00358475
- Sponsor's protocol ID
- FFR100688
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2006
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Perennial Allergic Rhinitis -Long Term Treatment Study-
- ClinicalTrials.gov ID
- NCT00358475
- Acronym / sponsor ID
- FFR100688
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- perennial allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2005
- Primary completion
- 1 Oct 2005 (actual)
- Study completion
- 12 Oct 2005 (actual)
- First posted
- 31 Jul 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.
This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent.
- Outpatient.
- Diagnosis of perennial allergic rhinitis with symptoms.
- Able to comply with study procedures.
Key exclusion criteria (4 listed)
- Significant concomitant medical condition.
- Use of corticosteroids/allergy medications.
- Laboratory abnormality.
- Positive pregnancy test.
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 |
|---|---|---|
| GW685698 | Drug | – |
Primary outcome
Adverse events and laboratory blood test
1 secondary outcome
Change of nasal symptom score
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 31 Aug 2018.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GW685698 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site.
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 4 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 31 Aug 2018. 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. 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?
Adverse events and laboratory blood test. 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 31 Aug 2018; AzTrials last refreshed its copy on 26 Oct 2026.