A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)
- Conditions
- Perennial Allergic Rhinitis
- Registration Number
- EUCTR2005-004493-25-EE
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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. Outpatient
• Subject is treatable on an outpatient basis.
3. Age
• > or = to 12 years at Visit 2 for US, Canada, Australia, New Zealand, Latvia, Lithuania, and Estonia
• > or = to 18 years at Visit 2 for Germany and Russia
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 for ALL females at the screening visit and the final visit. A urine pregnancy test will be performed at the randomization visit (Visit 2) and Visit 5.
5. Diagnosis of PAR to include:
• A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1.
A positive skin test is defined as a wheal > or = to 3mm larger than the diluent control for prick testing.
• Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms would include nasal congestion, rhinorrhea, nasal itching and sneezing.
In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.
NOTE: Subjects who meet the above criteria for PAR and who also have a history
of allergy to a seasonal pollen that will be present in their geographic area during
study participation are NOT eligible for randomization.
6. Environment
• Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain same environment throughout the study (e.g., exposure to animal dander should not change during the study).
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 in English or native language.
Randomization Criteria
At Visit 2, the subject must meet the following criteria:
1. Average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the four 24-hours periods prior to randomization must be > or = to 6. This includes the AM assessment on the morning of the randomization visit,
2.
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) or ocular injury or surgery in the last 3 months
d) asthma, with the exception of mild intermittent asthma NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
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 in the study
j) clinical evidence of a Candida infection of the nose or oropharynx
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
l) history of adrenal insufficiency
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. 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, or equivalent) 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 ‘nighttime’ pain formulations taken for insomnia, within 7 days prior to Visit 1
• Long-acting antihistamines within 10 days prior to Visit 1: including loratadine, desloratadine, fexofenadine, cetirizine, levocetirizine, terfenadine
• 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 any ocular antihistamines, eyewashes/nasal irrigation solutions, homeopathic preparations, or lubricants 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)
• Chronic use of other intranasally adminis
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