Perennial Allergic Rhinitis
Conditions
Interventions
Product Name: GW685698X
Product Code: GW685698X
Pharmaceutical Form: Nasal spray, suspension
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Informed consent • An appropriately signed and dated informed consent from the subject’s parent/legal guardian. Adequate provisions for assent of children should be provided in accordance with the IRB. 2. Subjects must be 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply. 1. Significant concomitant medical conditions, defined as but not limited to: a). A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema), which 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. b). a severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug c). eye or nose (e.g., nasal septum) surgery in the last 3 months d). asthma, with the exception of mild intermittent asthma, [NAEPP Guidelines, 2002 & GINA, 2003]. e). rhinitis medicamentosa f). bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within one week of Visit 1 or during the screening period g). documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator 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 the study j). clinical evidence of a Candida infection of the nose or oropharynx k). if the subject or his/her parent or legal guardian has a condition that will limit the validity of informed consent or that would confound the interpretation of the study results l). history of adrenal insufficiency or adrenal disorders m). 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. 2. Subjects who also have a seasonal exacerbation history within the last 12 months prior to Visit 1 3. Use of corticosteroids, defined as: • Oral, intramuscular, and/or intravenous within 6 months prior to Visit 1. • Inhaled, intranasal, and/or dermatological corticosteroid (with the exception of occasional use of hydrocortisone cream/ointment, 1% or less) within 8 weeks prior to Visit 1. 4. 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 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 weeks prior to Visit 1 • 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 NOTE: Subjects are not permitted to use nasal irrigation solutions, homeopathic preparations, mentholated ointments, or lubricants during the screening and treatment periods. No exclusion period prior to screening (Visit 1) is required for these treatments. 5. Use of other medications that may affect allergic rhinitis or its symptoms • Chronic use of concomitant medications, such as antidepressants, that would affect assessment of the effectiveness of the study drug • Chronic u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to compare the safety and efficacy of GW685698X aqueous nasal spray 50mcg and 100mcg once daily with vehicle placebo nasal spray over a period of 12 weeks and to determine the optimal dose in paediatric subjects ages 2 to <12 years with PAR.;Secondary Objective: The other objective of this study is to characterize the systemic exposure to GW685698X within the doses under study in paediatric subjects ages 2 to <12 years with PAR over a period of 12 weeks.;Primary end point(s): The primary efficacy endpoint will be the mean change from baseline over the first 4- week treatment period in daily, reflective total nasal symptom scores (rTNSS) in subjects ages 6 to <12 years. The total nasal symptom score (TNSS) is the sum of the 4 individual symptom scores for rhinorrhea, nasal congestion, nasal itching and sneezing where each symptom is scored on a scale of 0 to 3. 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 rTNSS is the average of the AM rTNSS and PM rTNSS assessments. The baseline score 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
Finland, Italy
Outcome results
None listed