Rhinitis, Allergic, SeasonalPhase 3NCT00363740
Study of GW685698X In Patients With Seasonal Allergic Rhinitis
A Phase 3 study testing GW685698X Aqueous Nasal Spray in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site.
Trial summary
This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. 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?
- GW685698X Aqueous Nasal Spray
- How many people
- 38 participants
- Where
- 1 siteLocation not given
- Study dates
- 19 Feb 2005to 13 Apr 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 seasonal 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
- Allergy to any component of investigational product
Trial locations and contacts
1 site in 1 country.
Location not given1 site
GSK Investigational Site
About this study
Official title: Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-
This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- GW685698X Aqueous Nasal Spray
- Keywords
- GW685698X, allergic rhinitis, Seasonal Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698X Aqueous Nasal SprayDrug
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 three total nasal symptom scores.
Secondary outcomes (2)
Mean change from baseline over the entire treatment period in four total nasal symptom scores.
Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study start19 Feb 2005
- Primary completion1 Apr 2005
- Study completion13 Apr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 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
- NCT00363740
- Sponsor's protocol ID
- FFR100652
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 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
- Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-
- ClinicalTrials.gov ID
- NCT00363740
- Acronym / sponsor ID
- FFR100652
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- GW685698X, allergic rhinitis, Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2005
- Primary completion
- 1 Apr 2005 (actual)
- Study completion
- 13 Apr 2005 (actual)
- First posted
- 15 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.
This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
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 seasonal allergic rhinitis with symptoms
- Able to comply with study procedures
Key exclusion criteria (5 listed)
- Significant concomitant medical condition
- Use of corticosteroids/allergy medications
- Laboratory abnormality
- Positive pregnancy test
- Allergy to any component of investigational product
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 Aqueous Nasal Spray | Drug | – |
Primary outcome
Mean change from baseline over the entire treatment period in three total nasal symptom scores.
2 secondary outcomes
Mean change from baseline over the entire treatment period in four total nasal symptom scores.
Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
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 GW685698X Aqueous Nasal Spray 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 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 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?
Mean change from baseline over the entire treatment period in three total nasal symptom scores.. 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.