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| Tracking Information | |||||
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| First Received Date ICMJE | August 21, 2007 | ||||
| Last Updated Date | October 13, 2008 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean change from baseline in daily rTNSS over the treatment period following treatment with FFNS vs. placebo and FPNS vs. placebo | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00519636 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
AM and PM rTNSS Health outcomes endpoints - subject experience with nasal sprays and subject preference for either nasal sprays | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS | ||||
| Official Title ICMJE | See Detailed Description | ||||
| Brief Summary | The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS. |
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| Detailed Description | A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105927) |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Seasonal Allergic Rhinitis | ||||
| Intervention ICMJE | Drug: fluticasone propionate, fluticasone furoate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 360 | ||||
| Completion Date | November 2007 | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following: Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days). Oral contraceptive (either combined estrogen/progestin or progestin only) Injectable progestogen Implants of levonorgestrel Percutaneous contraceptive patches Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year, Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide Estrogenic vaginal ring
SAR is defined as follows: A clinical history (written or verbal) of SAR with seasonal allergy symptoms (nasal symptoms) during each of the last two fall allergy seasons, and A positive skin test (by prick method) to fall allergen prevalent to the geographic area during the conduct of the study, within 12 months prior to Visit 1 or at Visit 1. A positive skin test is defined as a wheal 3 mm larger than the diluent control for prick testing. In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a diagnosis of SAR. Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for randomization.
Subject does not plan to travel outside this area for more than 48 hours of the study period.
Exclusion Criteria: Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST). Significant concomitant medical conditions, defined as but not limited to: A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). 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 (eg, nasal septum) injury or surgery in the last 3 months Asthma, with the exception of mild intermittent asthma [National Asthma Education and Prevention Program (NARPP) Guidelines, 2002]. 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 participate safely and fully 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 History of shingles Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last 3 weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease. Use of other corticosteroids, defined as: Intranasal corticosteroid within four weeks prior to Visit 1. 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. Use of other allergy medications within the timeframe indicated relative to Visit 1 Intranasal cromolyn within 14 days prior to Visit 1 Short-acting prescription and OTC antihistamines, including antihistamines contained in insomnia and 'nighttime' pain formulations taken for insomnia, within 3 days prior to Visit 1 Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine Oral or intranasal decongestants within 3 days prior to Visit 1 Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1 Oral antileukotrienes within 3 days prior to Visit 1 Subcutaneous omalizumab (Xolair) within 5 months of Visit 1 Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1 Use of other medications that may affect allergic rhinitis or its symptoms Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug Chronic use of long-acting beta-agonists (e.g., salmeterol) Chronic use of other intranasally administered medications (e.g., calcitonin-salmon) Nasal irrigation solutions Use of immunosuppressive medications 8 weeks prior to screening and during the study Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole Immunotherapy Subjects may be enrolled into the study if the immunotherapy was not initiated within 30 days of Visit 1, 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. Allergy/Intolerance Known hypersensitivity to corticosteroids or any excipients in the product Clinical trial/experimental medication experience Has recent exposure to an investigational study drug within 30 days of Visit 1 Participation in a previous or current GSK FFNS study Positive or inconclusive pregnancy test or female who is breastfeeding Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2 Affiliation with investigational site Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned. Current tobacco use Subject currently uses smoking products including cigarettes, cigars, and pipe or chewing tobacco. Subject must be able to read, comprehend, and record information in English. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00519636 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | FFU105927 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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