Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Centre, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via nasal Biopsy in Subjects =18 Years of Age with Perennial Allergic Rhinitis (PAR).

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-001771-35-BE
• Date of registration: 15/12/2005
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline Research & Development
• Public title: Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Centre, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via nasal Biopsy in Subjects =18 Years of Age with Perennial Allergic Rhinitis (PAR).
• Scientific title: Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Centre, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via nasal Biopsy in Subjects =18 Years of Age with Perennial Allergic Rhinitis (PAR).
• Date of first enrolment: 04/10/2005
• Target sample size: 155
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001771-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: control group of healthy volunteers (non-allergic) receiving no treatment.

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
Healthy (non-allergic) Control Inclusion Criteria
A healthy (non-allergic) control subject will be eligible for inclusion in this study if all of the following criteria apply:
1. Subject has provided an appropriately signed and dated informed consent.
2. Subject is at least 18 years of age at Visit 1, either gender, and any ethnic group.
3. Subject is willing, able and likely to attend study visits and comply with study procedures.
4. Subject is able to read, comprehend, and record information in the native language of the country where the study is being conducted.

PAR Subject Inclusion Criteria
A PAR subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Subject has provided an appropriately signed and dated informed consent.
2. Subject must be at least 18 years of age at Visit 1, either gender, and any ethnic group.
3. Female subjects of child-bearing 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 the study and is the sole sexual partner for that female subject
• Implants of levonorgestrel
• Injectable progestogen
• Oral contraceptive (either combined or progestin only)
• Double barrier method – spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide and female diaphragm).
• 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 and are not on one of the above acceptable methods of contraception 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).
• Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
• A serum pregnancy test will be done at the screening visit to confirm female subjects are not pregnant upon entry into the study.
4. Subject must have a diagnosis and history of perennial allergic rhinitis (PAR) as follows:
• Two year clinical history and treatment of PAR (written or verbal confirmation from the treating physician)
• and,
• Documented, positive skin test to an appropriate perennial allergen (animal dander, house dust mites, cockroaches and/or mold) or documented, positive in vitro test results for a specific IgE (such as RAST, PRIST) within the past 12 months prior to Visit 1 will be allowed. A positive skin test during Visit 1 will also be allowed. A positive skin test is defined as a wheal =3mm larger than the diluent control for prick testing.
• Note: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis (SAR) are eligible for randomization.
5. Subject is treatable on an outpatient basis.
6. Subject understands and is willing, able and likely to comply with study procedures and restrictions.
7. Subject is able to read, comprehend, and record information in the native language of the country where the study is being conducted.

Are the trial subjects under 18? no
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:
PAR Subject Exclusion Criteria
A PAR subject will not be eligible for inclusion in this study if the subject:
1. has a significant concomitant medical condition, defined as in the protocol:
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. currently uses or has a recent history (within the past 6 months) of using smoking
products including cigarettes, cigars, and pipe or chewing tobacco.
4. is hypersensitive to indigo carmine or saccharine if subject is at select site participating in the ICST assessment
5. has positive or inconclusive pregnancy test or female who is breastfeeding
6. is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.

PAR Subject Exclusion Criteria
A PAR subject will not be eligible for inclusion in this study if the subject:
1. has a significant concomitant medical condition, defined as in the protocol
• 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 cromolyn within 14 days prior to Visit 1
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: loratadine, desloratadine, fexofenadine, cetirizine
within 10 days prior to Visit 1
• Long-acting antihistamine: astemizole within 12 weeks prior to Visit 1
• Intranasal antihistamines (e.g. azelastine) within 2 weeks prior to Visit 1
• Oral or intranasal decongestants within 3 days of Visit 1
• Intranasal, oral or inhaled anticholinergics within 3 days prior to Visit 1
• Oral antileukotrienes within 3 days of Visit 1
• Subcutaneous omalizumab within 5 months of Visit 1
4. Use of other medications or treatments that may affect the signs and symptoms of
allergic rhinitis
• The anticipated need for the use of other intranasally administered medications
or treatments (e.g., calcitonin-salmon, nasal irrigation solutions) as they will not
be allowed after Visit 1.
• 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)
5. Immunotherapy
• Immunotherapy patients may be enrolled in the study as long as the immunotherapy was not initiated within 30 days of Visit 1, the dose has remained fixed over the 30 days prior to Visit 1, and no significant changes are made in the dose, concentration or dilution for the duration of the study.
6. Use of immunosuppressive medications 8 weeks prior to Visit 1 and during the study
7. Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
8. Allergy/Intolerance
• Known hypersensitivity to corticosteroids or any excipients in the nasal spray
products
•

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Perennial Allergic Rhinitis

Intervention(s)

Product Name: GW685698X
Product Code: GW685698X
Pharmaceutical Form: Nasal spray, suspension
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Nasonex®
Product Name: Nasonex®
Product Code: mometasone furoate aqueous nasal spray
Pharmaceutical Form: Nasal spray*
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.05-

Primary Outcome(s)

Primary end point(s): Quantitative and qualitative differences in the morphology and cytology of the nasal
mucosa before and after treatment will be based on the following parameters:
• epithelial thickness based on the ratio of cross sectional area to basement membranelength
• percentage of intact ciliated epithelium
• abundance of goblet cells
• extent of inflammatory cell infiltration (eosinophils, basophils, dendritic cells) in the epithelial tissue and sub-epithelial tissue

Main Objective: The primary objective of this study is to determine effects to the nasal mucosa of PAR subjects after one year of continuous treatment with GW685698X aqueous nasal spray 100mcg QD compared to a mometasone furoate aqueous nasal spray (Nasonex®) 200mcg QD reference control group as determined by blinded morphological and immunocytochemical analyses of nasal biopsy specimens. A separate healthy (nonallergic) control group of approximately 25 subjects will not receive any treatment, but will undergo a nasal biopsy at baseline and after 12 months to assess biopsy sampling technique artifact and monitor the influence of environmental factors over 12 months. ICST assessments of mucociliary clearance will also be conducted in subjects at one selected investigational site to determine the effects, if any, of treatment on ciliary function.

Secondary Objective:

Secondary ID(s)

FFR104503