Allergic RhinitisPhase 2NCT00400998
Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
A Phase 2 study testing Fluticasone Propionate in people with Allergic Rhinitis and Rhinitis, Allergic, Seasonal, run by Research Consult GmbH at 1 site in Austria.
Trial summary
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis, Rhinitis, Allergic, Seasonal
- What is being tested?
- Fluticasone Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2006to Nov 2006
- 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. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
- They have a history of seasonal allergic rhinitis
- Exhibit a moderate response to 1500 grass pollen grains per cubic metre after 2 hours in the Vienna Challenge Chamber at screening or within 12 months preceding the screening visit. A moderate response is defined as a total nasal symptom score of at least 6. (Total nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which has been scored on a scale from 0 to 3).
- They have a positive skin prick test (wheal size equal to or more than 4mm) for grass pollen at or within the 12 months preceding the screening visit.
- They have a positive RadioAllergoSorbent Test (RAST) (equal to or more than class 2) for grass pollen at or within the 12 months preceding the screening visit.
- They have demonstrated an ability to use the intranasal spray
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- There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 5 hours.
- They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form
- They are available to complete all study measurements
Who cannot join
- Pregnant or nursing females.
- Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception [i.e. implants of levonorgestrel, injectable progesterone, an acceptable intra-uterine device (IUD) (any IUD with a failure rate of less than 1% per year), oral contraceptives or any other method with a failure rate of <1% per year] for at least two weeks prior to the first dose of study medication and should continue using the same contraceptive measure until the final pregnancy test has been performed (not less than 72 hours after treatment). Alternatively they may be surgically sterilised (refer to section 6.4) or remain abstinent for 2 weeks before exposure to study drug.
- On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the responsible physician's opinion renders the subject unsuitable for participation in the study
- The subject has any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
- 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 that, in the opinion of the responsible physician, contraindicates their participation.
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- The subject has participated in a study with a new molecular entity during the previous 3 months or in any clinical study in the previous 2 months
- The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
- The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins and herbal remedies (e.g. St. John's Wort). Paracetamol and occasional as needed use of short-acting beta agonists is permitted
- The subject regularly, or on average, drinks more than 3 units of alcohol per day - where 1 unit = ½ pint of beer (284milliliteres mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
- The subject is at risk of non-compliance with the study procedures/restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, 2-way Crossover, 3 Phase Study, to Investigate the Trial Models, Vienna Challenge Chamber, in and Out of Season, and Park Study in Season and the Clinical Efficacy of Rpt Doses of Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis.
Read the detailed description
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis. This will be a single-centre, randomised, double-blind, placebo-controlled, 3 phase study in 40 male or female subjects with seasonal allergic rhinitis. The subjects will be randomised to receive either fluticasone propionate aqueous nasal spray or matched placebo. The study consists of three phases with each phase consists of 2 treatment periods. A screening visit will be followed by Phase 1 (Vienna Chamber Challenge out of season), Phase 2 (Park Study, in season) and Phase 3 (Vienna Chamber Challenge in season). There will be a follow-up visit after Phase 1 and Phase 2 \& 3 will be separated by a 10 day wash-out period. A follow-up visit will be completed 7-14 days after the last received dose. Intranasal fluticasone propionate will be administered daily for 8 days in the VCC and up to 14 days in the Park Study. Primary assessment will consist of major symptoms complex (MSC) during a 5-hour pollen allergen challenge in the Vienna Challenge Chamber (VCC) following final dosing on Day 8 and following final dosing between Day 8 and Day 14 in the Park Study. In addition, nasal flow measured by anterior rhinomanometry, wet tissue weight (as a surrogate of nasal secretion) and categorical scores for ocular symptoms, cough, itchy throat and itchy ears will be measured on day 8 (VCC) or on a day between 8-14 (Park).
- Conditions
- Allergic Rhinitis, Rhinitis, Allergic, Seasonal
- Being tested
- Fluticasone Propionate, Matched FPANS placebo
- Keywords
- Seasonal Allergic Rhinitis, Quality of Life, Efficacy, Validation, Fluticasone Propionate
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Subjects will receive the following treatment regimen over one of two dosing periods within each of the three study phases:
- Intranasal FPANS (Fluticasone Propionate aqueous nasal spray) 200 mcg once daily for 8 to 14 days i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL (microlitres) i.e. 50 mcg fluticasone propionate.
Matched FPANS placeboOther
Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases:
- Intranasal FPANS placebo once daily for 8 to 14 days (i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL.
| Study group | Role | What they receive |
|---|---|---|
| Vienna Challenge Chamber in season (Phase 3) | Placebo comparator | Phase 3 will consist of two treatment periods each lasting 8 days, with a 10 day wash-out between each treatment period.
Subjects will administer 200micrograms (μg) fluticasone propionate or fluticasone propionate matched placebo nasal spray, once daily for 8 days. Dosing will be supervised on the first and last days of each treatment period (Day 1 and Day 8).
Immediately following the last dose received on Day 8 the subject's signs and symptoms will be monitored: subjective symptom score every 15 minutes for rhinomanometry and measurement of nasal secretion every 30 minutes, and FEV1, AEs and symptoms of local irritancy. Receives: Drug: Fluticasone Propionate; Other: Matched FPANS placebo |
| Vienna Challenge Chamber out of season (Phase 1) | Placebo comparator | Phase 1 will consist of two treatment periods each lasting 8 days, with a 10 day wash-out between each treatment period.
Subjects will administer 200μg fluticasone propionate or fluticasone propionate matched placebo nasal spray, once daily for 8 days. Dosing will be supervised on the first and last days of each treatment period (Day 1 and Day 8).
Immediately following the last dose received on Day 8 the subject's signs and symptoms will be monitored: subjective symptom score every 15 minutes for rhinomanometry and measurement of nasal secretion every 30 minutes, and FEV1, AEs and symptoms of local irritancy.
An intermediate study follow-up visit will take place 7-14 days after the last dose is received in treatment period 2. Receives: Drug: Fluticasone Propionate; Other: Matched FPANS placebo |
| Park In Season (Phase 2) | Placebo comparator | Phase 2 will consist of 2 treatment periods lasting either 8 to 14 days (D) (depending on out-door conditions). There will be a 10D wash-out between this treatment period in Phase 2 and that in Phase 3.
Subjects will administer 200μg fluticasone propionate (or fluticasone propionate matched placebo nasal spray, once daily up to 14D, with dosing supervised on the first and last days of each treatment period (D1 and either D8 or up to D14).
Immediately following the last dose received on either D8 or up to D14 baseline measures will be taken (time = 0). The subject is then taken by bus to the Park and the first measurement will be taken 15 minutes after the subjects leave the bus and enter the Park.
Immediately following the last dose received on D8 or up to D14 the subject's signs and symptoms will be monitored: subjective symptom score every 15 minutes for rhinomanometry and measurement of nasal secretion every 30 minutes, and FEV1, AEs and symptoms of local irritancy Receives: Drug: Fluticasone Propionate; Other: Matched FPANS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted mean major symptom complex (MSC) sneeze, nasal itch, rhinorrhoea and itching eyes following 5 hours spent in the Vienna Challenge Chamber (VCC), in and out of season, and 5 hours in the Park Study in season.
Measured: 0-5 hour after last dose in either model
Secondary outcomes (10)
Weighted Mean Total Nasal Symptom Score (TNSS) in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Weighted mean eye symptom score in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Weighted mean global symptom score in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Weighted mean nasal airflow resistance in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Mean nasal secretion weight in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Forced Expiratory Volume in 1 second (FEV1) in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Adverse Events in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Symptoms of local irritancy in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Quality of life in both in-Chamber and Park studies
Measured: 0-5 hour after last dose in either model
Time until a 20% reduction is seen in TNSS, mean and global symptom scores, Nasal airflow resistance, Nasal secretion weight and FEV1
Measured: 2 hour after last dose in either model
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2006
- Study completionNov 2006
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.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Consult GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400998
- Sponsor's protocol ID
- HH3104994
- Status last verified
- Jan 2018
- First submitted
- 15 Nov 2006
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, 2-way Crossover, 3 Phase Study, to Investigate the Trial Models, Vienna Challenge Chamber, in and Out of Season, and Park Study in Season and the Clinical Efficacy of Rpt Doses of Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00400998
- Acronym / sponsor ID
- HH3104994
- Conditions
- Allergic Rhinitis, Rhinitis, Allergic, Seasonal
- Keywords
- Seasonal Allergic Rhinitis, Quality of Life, Efficacy, Validation, Fluticasone Propionate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Research Consult GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 17 Nov 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.
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis.
Detailed description
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis. This will be a single-centre, randomised, double-blind, placebo-controlled, 3 phase study in 40 male or female subjects with seasonal allergic rhinitis. The subjects will be randomised to receive either fluticasone propionate aqueous nasal spray or matched placebo. The study consists of three phases with each phase consists of 2 treatment periods. A screening visit will be followed by Phase 1 (Vienna Chamber Challenge out of season), Phase 2 (Park Study, in season) and Phase 3 (Vienna Chamber Challenge in season). There will be a follow-up visit after Phase 1 and Phase 2 \& 3 will be separated by a 10 day wash-out period. A follow-up visit will be completed 7-14 days after the last received dose. Intranasal fluticasone propionate will be administered daily for 8 days in the VCC and up to 14 days in the Park Study. Primary assessment will consist of major symptoms complex (MSC) during a 5-hour pollen allergen challenge in the Vienna Challenge Chamber (VCC) following final dosing on Day 8 and following final dosing between Day 8 and Day 14 in the Park Study. In addition, nasal flow measured by anterior rhinomanometry, wet tissue weight (as a surrogate of nasal secretion) and categorical scores for ocular symptoms, cough, itchy throat and itchy ears will be measured on day 8 (VCC) or on a day between 8-14 (Park).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vienna Challenge Chamber in season (Phase 3) | Placebo comparator | Drug: Fluticasone Propionate, Other: Matched FPANS placeboPhase 3 will consist of two treatment periods each lasting 8 days, with a 10 day wash-out between each treatment period. Subjects will administer 200micrograms (μg) fluticasone propionate or fluticasone propionate matched placebo nasal spray, once daily for 8 days. Dosing will be supervised on the first and last days of each treatment period (Day 1 and Day 8). Immediately following the last dose received on Day 8 the subject's signs and symptoms will be monitored: subjective symptom score every 15 minutes for rhinomanometry and measurement of nasal secretion every 30 minutes, and FEV1, AEs and symptoms of local irritancy. |
| Vienna Challenge Chamber out of season (Phase 1) | Placebo comparator | Drug: Fluticasone Propionate, Other: Matched FPANS placeboPhase 1 will consist of two treatment periods each lasting 8 days, with a 10 day wash-out between each treatment period. Subjects will administer 200μg fluticasone propionate or fluticasone propionate matched placebo nasal spray, once daily for 8 days. Dosing will be supervised on the first and last days of each treatment period (Day 1 and Day 8). Immediately following the last dose received on Day 8 the subject's signs and symptoms will be monitored: subjective symptom score every 15 minutes for rhinomanometry and measurement of nasal secretion every 30 minutes, and FEV1, AEs and symptoms of local irritancy. An intermediate study follow-up visit will take place 7-14 days after the last dose is received in treatment period 2. |
| Park In Season (Phase 2) | Placebo comparator | Drug: Fluticasone Propionate, Other: Matched FPANS placeboPhase 2 will consist of 2 treatment periods lasting either 8 to 14 days (D) (depending on out-door conditions). There will be a 10D wash-out between this treatment period in Phase 2 and that in Phase 3. Subjects will administer 200μg fluticasone propionate (or fluticasone propionate matched placebo nasal spray, once daily up to 14D, with dosing supervised on the first and last days of each treatment period (D1 and either D8 or up to D14). Immediately following the last dose received on either D8 or up to D14 baseline measures will be taken (time = 0). The subject is then taken by bus to the Park and the first measurement will be taken 15 minutes after the subjects leave the bus and enter the Park. Immediately following the last dose received on D8 or up to D14 the subject's signs and symptoms will be monitored: subjective symptom score every 15 minutes for rhinomanometry and measurement of nasal secretion every 30 minutes, and FEV1, AEs and symptoms of local irritancy |
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. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
- They have a history of seasonal allergic rhinitis
- Exhibit a moderate response to 1500 grass pollen grains per cubic metre after 2 hours in the Vienna Challenge Chamber at screening or within 12 months preceding the screening visit. A moderate response is defined as a total nasal symptom score of at least 6. (Total nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which has been scored on a scale from 0 to 3).
- They have a positive skin prick test (wheal size equal to or more than 4mm) for grass pollen at or within the 12 months preceding the screening visit.
- They have a positive RadioAllergoSorbent Test (RAST) (equal to or more than class 2) for grass pollen at or within the 12 months preceding the screening visit.
Key exclusion criteria (11 listed)
- Pregnant or nursing females.
- Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception [i.e. implants of levonorgestrel, injectable progesterone, an acceptable intra-uterine device (IUD) (any IUD with a failure rate of less than 1% per year), oral contraceptives or any other method with a failure rate of <1% per year] for at least two weeks prior to the first dose of study medication and should continue using the same contraceptive measure until the final pregnancy test has been performed (not less than 72 hours after treatment). Alternatively they may be surgically sterilised (refer to section 6.4) or remain abstinent for 2 weeks before exposure to study drug.
- On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the responsible physician's opinion renders the subject unsuitable for participation in the study
- The subject has any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
- The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
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 |
|---|---|---|
| Fluticasone PropionateSubjects will receive the following treatment regimen over one of two dosing periods within each of the three study phases: - Intranasal FPANS (Fluticasone Propionate aqueous nasal spray) 200 mcg once daily for 8 to 14 days i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL (microlitres) i.e. 50 mcg fluticasone propionate. | Drug | Park In Season (Phase 2), Vienna Challenge Chamber in season (Phase 3), Vienna Challenge Chamber out of season (Phase 1) |
| Matched FPANS placeboSubjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases: * Intranasal FPANS placebo once daily for 8 to 14 days (i.e. 4 actuations (2 per nostril) daily, where each actuation delivers a volume of 100 mcL. | Other | Park In Season (Phase 2), Vienna Challenge Chamber in season (Phase 3), Vienna Challenge Chamber out of season (Phase 1) |
Primary outcome
Weighted mean major symptom complex (MSC) sneeze, nasal itch, rhinorrhoea and itching eyes following 5 hours spent in the Vienna Challenge Chamber (VCC), in and out of season, and 5 hours in the Park Study in season.
Time frame: 0-5 hour after last dose in either model
10 secondary outcomes
Weighted Mean Total Nasal Symptom Score (TNSS) in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Weighted mean eye symptom score in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Weighted mean global symptom score in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Weighted mean nasal airflow resistance in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Mean nasal secretion weight in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Forced Expiratory Volume in 1 second (FEV1) in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Adverse Events in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Symptoms of local irritancy in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Quality of life in both in-Chamber and Park studies
Time frame: 0-5 hour after last dose in either model
Time until a 20% reduction is seen in TNSS, mean and global symptom scores, Nasal airflow resistance, Nasal secretion weight and FEV1
Time frame: 2 hour after last dose in either model
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 10 Jan 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 2 study testing Fluticasone Propionate in people with Allergic Rhinitis and Rhinitis, Allergic, Seasonal, run by Research Consult GmbH 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 11 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 10 Jan 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 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. 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?
Weighted mean major symptom complex (MSC) sneeze, nasal itch, rhinorrhoea and itching eyes following 5 hours spent in the Vienna Challenge Chamber (VCC), in and out of season, and 5 hours in the Park Study in season. (time frame: 0-5 hour after last dose in either model). 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 10 Jan 2018.