- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400998
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 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, A-1150
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Vienna Challenge Chamber in season (Phase 3)
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. |
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. Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases:
|
PLACEBO_COMPARATOR: Vienna Challenge Chamber out of season (Phase 1)
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. |
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. Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases:
|
PLACEBO_COMPARATOR: Park In Season (Phase 2)
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 |
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. Subjects will receive the following placebo treatment regimen over one of two dosing periods within each of the three study phases:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0-5 hour after last dose in either model
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
2 hour after last dose in either model
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
Other Study ID Numbers
- HH3104994
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationCompletedAllergy | Perennial Allergic Rhinitis | Seasonal Allergic RhinitisUnited States
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsCompletedAllergic Rhinitis | Perennial Allergic Rhinitis | Non-seasonal Allergic RhinitisKorea, Republic of
-
Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
Clinical Trials on Fluticasone Propionate
-
University of FloridaFood and Drug Administration (FDA)Completed
-
GlaxoSmithKlineCompleted
-
Teva Pharmaceuticals USATerminatedSeasonal Allergic RhinitisUnited States
-
PfizerCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Philippines, Canada, Brazil
-
Padagis LLCCompleted
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
Boehringer IngelheimCompletedAsthmaUnited States, Australia, Canada, Colombia, Korea, Republic of, Mexico, New Zealand, Peru, Philippines, Taiwan