Rhinitis, Allergic, SeasonalPhase 3NCT00225823
Study In Adults And Adolescents With Seasonal Allergic Rhinitis.
A Phase 3 study testing GW685698X in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 24 sites in 6 countries.
Trial summary
Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- GW685698X
- How many people
- 288 participants
- Where
- 24 sitesin 6 countries
- Study dates
- May 2005to Aug 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
- Informed consent.
- Must be an outpatient.
- Females must be using appropriate contraception.
- Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
- Must be able to comply with study procedures.
- Must be literate.
Who cannot join
- A significant concomitant medical condition.
- Use of corticosteroids or allergy or medications or tobacco.
- Clinically significant abnormal ECG.
- Laboratory abnormality.
- Positive pregnancy test.
- Allergy to any component of the investigational product.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Netherlands6 sites
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Arnhem, 6824 BJ
GSK Investigational Site
Assen, 9401 RK
GSK Investigational Site
Leeuwarden, 8934 AD
GSK Investigational Site
Schiedam, 3116 BA
GSK Investigational Site
Tilburg, 5038 NM
Latvia5 sites
GSK Investigational Site
Liepāja, LV3401
GSK Investigational Site
Riga, LV 1001
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1003
GSK Investigational Site
Riga, LV 1004
Lithuania4 sites
GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Kaunas, LT-50425
GSK Investigational Site
Šiauliai, LT-78242
GSK Investigational Site
Vilnius, LT-08661
Sweden4 sites
GSK Investigational Site
Ängelholm, SE-262 81
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Malmö, SE-211 36
GSK Investigational Site
Västerås, SE-721 89
Russia3 sites
GSK Investigational Site
Moscow, 115446
GSK Investigational Site
Saint Petersburg, 190013
GSK Investigational Site
Volgograd, 400130
Estonia2 sites
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 51014
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe
Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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. Commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- GW685698X
- Keywords
- Seasonal Allergic Rhinitis Intranasal Corticosteroid
- Medical subject headings
- 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.
Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
Secondary outcomes (1)
Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionAug 2005
- Study completionAug 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
- 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
- NCT00225823
- Sponsor's protocol ID
- FFR103184
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2005
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- 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 Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe
- ClinicalTrials.gov ID
- NCT00225823
- Acronym / sponsor ID
- FFR103184
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Seasonal Allergic Rhinitis Intranasal Corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 26 Sep 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.
Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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. Commonly referred to as 'hay fever', it is characterized by 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
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent.
- Must be an outpatient.
- Females must be using appropriate contraception.
- Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
- Must be able to comply with study procedures.
Key exclusion criteria (6 listed)
- A significant concomitant medical condition.
- Use of corticosteroids or allergy or medications or tobacco.
- Clinically significant abnormal ECG.
- 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 |
|---|---|---|
| GW685698X | Drug | – |
Primary outcome
Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
1 secondary outcome
Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.
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, Seasonal
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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
24 sites in 6 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, Seasonal, run by GlaxoSmithKline at 24 sites in 6 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 6 inclusion and 6 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 24 sites in Netherlands, Latvia, Lithuania, Sweden, Russia and 1 more country. 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 (rTNSS).. 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.