A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic Rhinitis
- Conditions
- Vasomotor/Idiopathic Rhinitis
- Registration Number
- EUCTR2004-004743-22-NO
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method