Vasomotor/Idiopathic Rhinitis
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject will be eligible for inclusion only if all of following criteria apply: 1. Informed consent • Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age. 2. Subject is treatable on an outpatient basis. 3. Age - = 12 years at Visit 2 4. Male or eligible female To be eligible for entry, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: • Male partner who is sterile prior to the female subject’s entry into study and is sole sexual partner for that female subject • Implants of levonorgestrel • Injectable progestogen • Oral contraceptive (either combined estrogen/progestin or progestin only) • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or • Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for 2weeks 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). • Double barrier method – spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide and female diaphragm). Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A serum pregnancy test will be performed at screening visit and final/early withdrawal visit. A urine pregnancy test will be performed at randomization visit (Visit 2) and Visit 4. 5. Diagnosis of VMR/IR to include ALL of the following: a Two year clinical history of VMR/IR (written or verbal confirmation) and evidence to support the perennial nature of the disorder and its potential fluctuation with weather conditions, such as, seasonal changes, abrupt changes in temperature, weather fronts, and variations in humidity, along with symptoms provoked by respiratory irritant exposure (e.g., tobacco smoke, perfumes, paint fumes). VMR/IR chronic symptoms would include rhinorrhea, nasal congestion and postnasal drip. b Subjects must have checked at least 3 of the Inhaled/Strong Odor and/or Weather/Temperature Change Triggers (making their VMR/IR symptoms worse) included on the Vasomotor/Idiopathic Rhinitis Questionnaire completed at Visit 1. c Negative skin tests (by prick method), response to seasonal allergens (including tree, grass and weed pollens) and perennial allergens (including animal dander, house dust mites, cockroach and mold) relevant to the geographical area completed at Visit 1. A negative response for allergen skin prick testing is defined as a wheal < 3 mm
Exclusion criteria
Exclusion criteria: Subject will not be eligible for inclusion if any of following criteria apply: 1. Significant concomitant medical conditions, defined as but not limited to: a Historical/current evidence of clinically significant uncontrolled disease of any body system. Significant is defined as any disease that, in the opinion of investigator, would put safety of subject at risk through study participation or which would confound the interpretation of study results if disease/condition exacerbated during study. b severe physical obstruction of the nose/nasal septal perforation that could affect deposition of double blind intranasal study drug c nasal/throat injury or surgery in last 3 mths d asthma, with exception of mild intermittent asthma. e rhinitis medicamentosa f bacterial/viral infection of upper respiratory tract within 2 wks of Visit 1 or during screening period g documented evidence of acute or significant chronic sinusitis, as determined by sinus radiograph (Waters view) done at Visit 1 h current or history of glaucoma and/or cataracts or ocular herpes simplex i physical impairment that would affect subject’s ability to participate in study j clinical evidence of Candida infection of nose or oropharynx k history of psychiatric disease, intellectual deficiency, poor motivation, substance abuse, or other conditions that will limit validity of informed consent or that would confound interpretation of study results l history of or current use of cocaine m history of adrenal insufficiency n history of shingles o Subject not eligible if has chickenpox/measles, or has been exposed during last 3 wks and is non-immune. If a subject develops chickenpox/ measles during study, they will be withdrawn. If a non-immune subject is exposed during study, their continuation will be at discretion of investigator, taking into consideration likelihood of developing active disease. 2. Use of corticosteroids, defined as: • Intranasal corticosteroid within 4 wks prior to Visit 1. • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with exception of hydrocortisone cream/ointment, 1% or less) within 8 wks prior to Visit 1. 3. Use of other allergy medications within timeframe indicated relative to Visit 1 • Intranasal or ocular cromolyn within 14 days prior to Visit 1 • Short-acting prescription and OTC antihistamines, including ocular preparations and 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 • Long-acting antihistamine, astemizole, within 12 wks prior to Visit 1 • Oral or intranasal decongestants within 3 days prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy and safety of GW685698X 100 mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (= 12 years of age) with vasomotor rhinitis (VMR)/idiopathic rhinitis (IR).;Secondary Objective: ; Primary end point(s): • Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores (rTNSS). The total nasal symptom score (TNSS) is the sum of the 3 individual symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom is scored on a scale of 0 to 3. The maximum sum for TNSS is 9. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS) and PM (PM rTNSS). The daily reflective total nasal symptom score (rTNSS) is defined as the average of the AM rTNSS and PM rTNSS assessments. The baseline TNSS is defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment the morning of randomization prior to study drug administration. | — |
Countries
Czech Republic, Germany, Norway
Outcome results
None listed