Rhinitis, Allergic, SeasonalPhase 2NCT00430157
Trial With Allergic Rhinitis Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber
A Phase 2 study testing GSK256066 in people with Rhinitis, Allergic, Seasonal and Seasonal Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Austria.
Trial summary
This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Seasonal Allergic Rhinitis
- What is being tested?
- GSK256066
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2007to not given
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject is healthy.
- They are aged 18 to 50 years inclusive.
- Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
- They have a history of seasonal allergic rhinitis
- They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber,
- They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
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- They have a positive RAST for grass pollen at or within the 12 months preceding the screening visit.
- They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit
- They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum recorded value)/ FVC (associated value)>70% predicted.
Who cannot join
- Pregnant or nursing females.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
- any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection.
- The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
- The subject has a history of drug or other allergy
- The subject is concurrently participating in another clinical study in the past 3 months
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- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- The subject has donated a unit of blood within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8 Day, Randomised, Double Blinded, Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)
This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD.
Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used.
Read more
This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.
12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
- Being tested
- GSK256066
- Keywords
- Vienna Challenge Chamber, Seasonal Allergic Rhinitis, Inflammation
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK256066Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Measured: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7
Secondary outcomes (1)
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Measured: 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJan 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 45 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
- NCT00430157
- Sponsor's protocol ID
- IPR107498
- Status last verified
- Feb 2011
- First submitted
- 30 Jan 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Day, Randomised, Double Blinded, Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT00430157
- Acronym / sponsor ID
- IPR107498
- Keywords
- Vienna Challenge Chamber, Seasonal Allergic Rhinitis, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- First posted
- 1 Feb 2007 (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 is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD.
Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used.
This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.
12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subject is healthy.
- They are aged 18 to 50 years inclusive.
- Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
- They have a history of seasonal allergic rhinitis
- They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber,
Key exclusion criteria (9 listed)
- Pregnant or nursing females.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
- any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection.
- The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
- The subject has a history of drug or other allergy
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 |
|---|---|---|
| GSK256066 | Drug | – |
Primary outcome
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Time frame: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7
1 secondary outcome
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Time frame: 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.
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 4 Jun 2012.
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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 GSK256066 in people with Rhinitis, Allergic, Seasonal and Seasonal Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Austria.
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 9 inclusion and 9 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 4 Jun 2012. 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 Austria. 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 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?
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction) (time frame: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7). 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 4 Jun 2012.