A randomized, double-blind, placebo-controlled, parallel group, multicenter twoweek study to evaluate the efficacy and safety of once-daily, intranasaladministration of GW685698X aqueous nasal spray 100 mcg in adult andadolescent subjects with seasonal allergic rhinitis in Europe

• Conditions: Seasonal allergic rhinitis (SAR)

• Registration Number: EUCTR2004-004434-14-LT
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-25
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the 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 under 18 years of age.
2. Outpatient
• Subject is treatable on an outpatient basis.
3. Age =12 years at Visit 2
4. Male or eligible female
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:
• Male partner who is sterile prior to the female subject's entry into the study and
is the 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 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).
• 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 the
screening visit and the final visit. A urine pregnancy test will be performed at the
randomization visit.
5. Diagnosis of seasonal allergic rhinitis (SAR)
SAR is defined as follows:
• Documented clinical history of SAR with seasonal onset and offset of nasal
allergy symptoms during each of the last 2 grass pollen seasons and
• A positive skin test (by prick method) to a grass pollen that will be abundant in
the subjects environment during the course 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.
Historical in vitro tests for specific IgE (such as RAST, PRIST) will be allowed as a
diagnosis of SAR if conducted less than 12 months prior to Visit 1.
Subjects who meet the above criteria and who may also have perennial allergic
rhinitis or vasomotor rhinitis are still eligible for randomization.
6. Adequate exposure to the relevant grass pollen
• Subject resides within a geographical region where exposure to the pollen that
triggers their SAR symptoms and is predicted to be significant during the entire
study period.
• Subject does not plan to travel outside the geographical region where exposure
to the relevant grass pollen is expected to be significant for more than 48 hours
of the study period.
7. Ability to comply with study procedures
• Subject understands and is willing, able and likely to comply with study
procedures and restrictions.
8. Literate
• Subject must be able to read, comprehend, and record information as
appropriate.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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).
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. nasal (e.g., nasal septum), ocular, or throat injury or surgery in the last 3 months
d. asthma, with the exception of mild intermittent asthma (NAEPP, 2002 and GINA, 2003).
e. rhinitis medicamentosa
f. 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
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 safely and
fully in the study
j. clinical evidence of a Candida infection of the nose
k. 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
2. Use of 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.
3. Use of other allergy medications within the 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 night time pain formulations,
within 3 days prior to Visit 1
• Long-acting antihistamines within 10 days prior to Visit 1 (e.g., loratadine,
desloratadine, fexofenadine, cetirizine)
• Intranasal antihistamines (e.g., Astelin/ ) within 2 weeks prior to Visit 1
• Oral or intranasal decongestants within 72 hours prior to Visit 1
• Long-acting beta-agonists within 72 hours prior to Visit 1
• Intranasal, oral, or inhaled anticholinergics within 72 hours prior to Visit 1
• Oral antileukotrienes within 72 hours of Visit 1
• Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
• Subjects are not permitted to use any ocular antihistamines, artificial tears,
eyewashes/nasal irrigation solutions, allergy homeopathic or herbal
preparations, lubricants, sympathomimetic or vasoconstrictor preparations
during the screening and treatment periods. No exclusion period prior to
screening (Visit 1) is required for these treatments.
4. 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)
• Use of other intranasally administered medications (e.g., calcitonin-salmon)
• Use of throat treatments (e.g., such as cough lozenges, throat sprays)
5. Use of immunosuppressive medications 8 weeks prior to screening and during the
study
6. Immunotherapy
Immunotherapy patients may be enrolled in the study as long as the immunother

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified