Last updated: 11/07/2018 11:38:46
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study 200165, A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Compare the Efficacy of a 2-Week Treatment with Fluticasone Propionate Nasal Spray versus Cetirizine in Adult Subjects with Seasonal Allergic Rhinitis (SAR)
Trial description: This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline (CFB) in the individual AM reflective total nasal symptom scores (rTNSS) over the entire treatment period
Timeframe: Baseline through the entire treatment period (2 weeks)
Secondary outcomes:
Mean change from Baseline in the individual AM reflective nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing over the entire treatment period
Timeframe: Baseline through the entire treatment period (2 weeks)
Mean change from Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) overall score at Visit 3/Early Withdrawal.
Timeframe: Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal
Mean change from Baseline in the AM pre-dose instantaneous Total Nasal Symptom Score (iTNSS) over the entire treatment period
Timeframe: Baseline through the entire treatment period (2 weeks)
Mean change from Baseline in the AM pre-dose reflective Total Ocular Symptom Score (rTOSS) over the entire treatment period
Timeframe: Baseline through the entire treatment period (2 weeks)
Mean change from Baseline in the AM pre-dose instantaneous Total Ocular Symptom Score (iTOSS) over the entire treatment period
Timeframe: Baseline through the entire treatment period (2 weeks)
Mean change from Baseline in the combined nasal and ocular reflective Total Symptom Score (rTSS = rTNSS+rTOSS) over the entire treatment period
Timeframe: Baseline through the entire treatment period (2 weeks)
Interventions:
Drug: FPNS
Drug: FPNS Placebo
Drug: Cetirizine
Drug: Cetirizine Placebo
Enrollment:
682
Observational study model:
Not applicable
Primary completion date:
2013-17-10
Time perspective:
Not applicable
Clinical publications:
Ford LB, Matz J, Hankinson T, Prillaman B, Georges G.A comparison of fluticasone propionate nasal spray and cetirizine in ragweed fall seasonal allergic rhinitis.Allergy Asthma Proc.2015;36(4):313-9
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
cetirizine, fluticasone propionate
Collaborators
Not applicable
Study date(s)
August 2013 to October 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion Criteria
- Informed consent: Subject must give their signed and dated written informed consent to participate. Subject must understand and be willing, able, and likely to comply with study procedures and restrictions. Subject must be able to read, comprehend, and record information in English.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Informed consent: Subject must give their signed and dated written informed consent to participate. Subject must understand and be willing, able, and likely to comply with study procedures and restrictions. Subject must be able to read, comprehend, and record information in English.
- Subject is treatable on an outpatient basis.
- Age: >=18 years of age at Visit 1.
- Gender: Male or eligible female subjects. A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. OR Childbearing potential with a negative pregnancy test at screening and agreeable to using one of the acceptable contraceptive methods consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study). An eligible female is also not lactating nor planning on becoming pregnant during the study.
- Diagnosis of SAR, defined as documented clinical history or physician verification of subject reported historical SAR during each of the last two fall allergy seasons and a positive skin prick test (wheal >=3 millimeter [mm] larger than the negative control) to a prevalent local fall allergen within 12 months prior to Visit 1 or at Visit 1.
- Adequate exposure to local fall pollen: Subject resides within a geographical region where exposure to the local fall pollen to which they are sensitized is expected to be moderate or greater during the study period. Subject does not plan to travel outside the geographical region where exposure to local fall pollen to which they are sensitized is expected to be moderate or greater for more than 48 hours during the study period. At Visit 2, the subject must meet the following criteria
- Eligible subjects will need to have moderate to severe SAR symptoms, defined as a morning rTNSS of >=7 on at least four of the last seven days leading up to randomization. This includes the AM assessment on the morning of the randomization visit at Visit 2.
- Subjects should demonstrate at least a 70% compliance rate with both their placebo run-in study medications and their e-diary completion prior to randomization. This period includes the day of Visit 1 until the day before randomization at Visit 2.
- Subjects should have no significant change in medical condition(s) that would have been exclusionary at Visit 1.
- Subjects should not have used any prohibited medications that are detailed in the inclusion/exclusion criteria (including prohibited allergy medications).
- Subjects should not have travelled outside the local pollen region for more than 48 hours during the run-in period. Exclusion Criteria
- Significant concomitant medical conditions, defined as but not limited to: Historical or current evidence of a clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema, uncontrolled asthma). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study. A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug. Nasal (e.g., nasal septum), ocular, or throat injury, or surgery to these areas in the last 3 months. Rhinitis medicamentosa. Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period. Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator. Current or history of glaucoma and/or cataracts or ocular herpes simplex. Physical impairment that would affect subject’s ability to safely and fully participate in the study. Clinical evidence of a Candida infection of the nose. History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results. History of adrenal insufficiency.
- Use of corticosteroids, defined as: Intranasal corticosteroid within four weeks prior to Visit 1 and during the treatment period. Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1 and during the treatment period.
- Use of allergy medications, within a timeframe relative to Visit 1, that would prevent the medication from being eliminated and/or have an effect. Exclusionary timeframes relative to Visit 1 for five common allergy treatments are noted below Intranasal cromolyn (<=2 weeks from Visit 1). Intranasal or systemic decongestants (<=3 days from Visit 1). Intranasal or systemic (other than oral) antihistamines (<=3 days from Visit 1). Leukotriene modifiers (<=3 days from Visit 1). Oral antihistamines (<=2 days from Visit 1). Allergy medications, other than study supplied medications, are not allowed during the study.
- Use of other medications that may affect allergic rhinitis or its symptoms, e.g., use of any ocular antihistamines, artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening and treatment periods
- Use of any medications (prescription or non-prescription) or alcohol to induce sleep 48-hours prior to Visit 1 and during the treatment period.
- Use of other intranasally administered medications (e.g., calcitonin), including herbals and homeopathics during the run-in (Visit 1
- Visit 2) and treatment period.
- Use of immunosuppressive medications within 8 weeks prior to screening and during the treatment period.
- Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4 (e.g., ritonavir, ketoconazole) during the run-in (Visit 1
- Visit 2) and treatment period.
- Known hypersensitivity to corticosteroids or any excipients present in the nasal spray.
- Known hypersensitivity to cetirizine or any excipients in the tablet.
- Recent exposure to an investigational study drug or device within 30 days of Visit 1.
- Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
- Chickenpox or measles during the last 3 weeks prior to screening and is non-immune.
- Immunotherapy is exclusionary unless the immunotherapy was initiated >=30 days from Visit 1 and if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years which in the opinion of the investigator could interfere with the subject’s proper completion of the protocol requirement.
Trial location(s)
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66210
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-17-10
Actual study completion date
2013-17-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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