Allergic RhinitisPhase 2NCT00824356
Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
A Phase 2 study testing GSK1004723 (200mg) and GSK1004723 (1000mg) in people with Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- GSK1004723 (200mg) and GSK1004723 (1000mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Aug 2008
- Phase
- Phase 2
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Male
- Aged 18 - 65
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
- Non-smoker
- Capable of giving informed consent
Who cannot join
- No nasal structural abnornmality/polyposis, surgery, infection.
- any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- participated in another clinical study within 30 days.
- Subject has donated a unit of blood within 1 month
- Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- History of sensitivty to drug
Show all 13Show fewer
- History of alcohol/drug abuse within 12 months.
- Positive Hepatitis B antibody test
- Positive HIV antibody test
- Risk of non-compliance with study protocol
- Perenial allergic rhinitis
- Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
- Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic
- Conditions
- Allergic Rhinitis
- Being tested
- GSK1004723 (200mg), Placebo, GSK1004723 (1000mg)
- Keywords
- Allergic Rhinitis, Proof-of-Concept
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1004723 (200mg)Drug
Intranasal antihistamine.
PlaceboOther
Equivalent to GSK1004723 in presentation etc.
GSK1004723 (1000mg)Drug
Intranasal antihistamine.
| Study group | Role | What they receive |
|---|---|---|
| GSK1004726 (1000mg) | Active comparator | 1000mg aqueous suspension Receives: Drug: GSK1004723 (1000mg) |
| Placebo | Placebo comparator | Intranasal spray Receives: Other: Placebo; Drug: GSK1004723 (1000mg) |
| GSK1004723 (200mg) | Active comparator | 200 mg aqueous suspension Receives: Drug: GSK1004723 (200mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total nasal symptom score 0-4 hours post dose
Measured: 0-4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824356
- Sponsor's protocol ID
- 110159
- Other IDs
- 723 PoC
- Status last verified
- Jun 2009
- First submitted
- 8 Jan 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00824356
- Acronym / sponsor ID
- 110159
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Proof-of-Concept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Jan 2009 (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 is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK1004726 (1000mg) | Active comparator | Drug: GSK1004723 (1000mg)1000mg aqueous suspension |
| Placebo | Placebo comparator | Other: Placebo, Drug: GSK1004723 (1000mg)Intranasal spray |
| GSK1004723 (200mg) | Active comparator | Drug: GSK1004723 (200mg)200 mg aqueous suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Male
- Aged 18 - 65
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
Key exclusion criteria (13 listed)
- No nasal structural abnornmality/polyposis, surgery, infection.
- any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- participated in another clinical study within 30 days.
- Subject has donated a unit of blood within 1 month
- Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
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 |
|---|---|---|
| GSK1004723 (200mg)Intranasal antihistamine. | Drug | GSK1004723 (200mg) |
| PlaceboEquivalent to GSK1004723 in presentation etc. | Other | Placebo |
| GSK1004723 (1000mg)Intranasal antihistamine. | Drug | GSK1004726 (1000mg), Placebo |
Primary outcome
Change from baseline in total nasal symptom score 0-4 hours post dose
Time frame: 0-4 hours post dose
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 22 Jun 2009.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
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Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
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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 2 study testing GSK1004723 (200mg) and GSK1004723 (1000mg) in people with Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Germany.
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 7 inclusion and 13 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 22 Jun 2009. 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 in Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in total nasal symptom score 0-4 hours post dose (time frame: 0-4 hours post dose). 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 22 Jun 2009; AzTrials last refreshed its copy on 1 Nov 2026.