| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Perennial Allergic Rhinitis |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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. |
|
| E.2.2 | Secondary objectives of the trial |
| 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. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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 <12 years of age at Visit 2, either gender, any ethnic group.
• Only premenarchal female subjects (of non-child bearing potential) are eligible
to participate in this study.
3. Subject is treatable on an outpatient basis.
4. Diagnosis of PAR to include:
• A positive test (by skin prick or in vitro test results for a specific IgE [such as
RAST, PRIST]) response to appropriate perennial allergen (animal dander,
house dust mites, cockroach, mold) within last 12 months prior to Visit 1. If a
subject has not been tested prior to Visit 1, a positive skin test (by prick method)
is required at Visit 1.
A positive skin test is defined as a wheal ≥3mm larger than the diluent control for prick testing.
•Medical history and past treatment of PAR (written or verbal confirmation from the
treating physician) which includes perennial, i.e., year-round, symptoms. PAR
symptoms would include nasal congestion, rhinorrhea, sneezing and nasal itching.
• For 4 to <12 years of age, one year clinical history and treatment of PAR
• For 2 to <4 years of age, 6 month clinical history and treatment of PAR
NOTE: Subjects who meet the above criteria for PAR and who also have a seasonal
exacerbation history (e.g., grass, tree, or weed pollen) within the last 12 months prior to Visit 1 are NOT eligible for randomization.
5. Environment
• Subject must be symptomatic to appropriate perennial allergen (e.g., animal
dander, house dust mites, cockroach, or mold) and willing to maintain same
environment throughout the study (e.g., subject’s exposure to animal dander
should not change during the study).
6. Subject and/or subject’s parent/guardian understands and is willing, able and likely to comply with study procedures and restrictions as well as manage study drug
administration.
7. Subject and/or subject’s parent/guardian must be able to read, comprehend, and
record information in English or native country language. |
|
| E.4 | Principal 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 use of long-acting beta2-agonists (e.g., salmeterol)
• Chronic use of other intranasally administered medications (e.g., calcitonin-salmon)
6. Use of immunosuppressive medications 8 weeks prior to Visit 1 and during the study
7. Immunotherapy
• Immunotherapy patients may be enrolled in the study as long as the
immunotherapy was not initiated within 30 days of Visit 1 and if the dose has
remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed
for the duration of the study
8. Use of any medications that significantly inhibit the cytochrome P450 subfamily
enzyme CYP3A4, including ritonavir and ketoconazole
9. Allergy/Intolerance
• Known hypersensitivity to corticosteroids or any excipients in the product
10. Clinical trial/experimental medication experience
• Has recent exposure to an investigational study drug within 30 days of Visit 1
Participation in a previous or current GSK GW685698X study
11. Affiliation with investigational site
• Participation of site personnel, or their spouse or children will not be allowed.
Subject is a participating investigator, sub-investigator, study co-ordinator, or
employee of a participating investigator, or is an immediate family member of
the aforementioned.
12. Findings of a clinically significant, abnormal ECG
13. Findings of a clinically significant laboratory abnormality |
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
| E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
Print
