| Eligibility |
Inclusion Criteria:
1. Provide written informed consent.
2. Male or female subjects (childbearing and non-childbearing potential, defined as
females with no menstruation for a minimum of 12 months prior to screening) aged 18 to
55 years (inclusive) at screening.
3. History of SAR to ragweed pollen for at least the previous 2 ragweed pollen seasons.
4. Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal
diameter at least 3 mm larger than the negative control). A test performed in the
previous 12 months may be used to qualify the subject.
To be eligible for Visit 2 EEC, a subject must additionally comply with the following
criteria:
5. Asymptomatic or with mild symptoms during the baseline recording of symptoms prior to
start of the screening EEC (Visit 2):
- TNSS = 3/12 with the score for each symptom being less than 2.
To be eligible for Visit 3, a subject must additionally comply with the following
criteria during Visit 2 EEC:
6. Demonstrate adequate symptomology:
- TNSS = 6/12 on at least two ePDAT™ time point assessments during hours 0-2 in the
EEC (Visit 2), with at least one occurring during the last two time points.
Additionally, subjects will be required to meet a score of at least 2/3 for runny nose
at least twice during hours 0-2 in the EEC, with at least one occurring during the
last two time points.
To be eligible for randomisation (Visit 3), a subject must additionally comply with
the following criteria:
7. Demonstrate adequate symptomology:
- TNSS = 6/12 on at least two ePDAT™ time point assessments during hours 0-2 in the
EEC (Visit 3), with at least one occurring during the last two time points.
Additionally, subjects will be required to meet a score of at least 2/3 for runny
nose at least twice during hours 0-2 in the EEC, with at least one occurring
during the last two time points.
- No evidence of complete nasal blockage on either one or both sides on anterior
rhinoscopy within 30 minutes prior to dosing.
Exclusion Criteria:
Safety concerns:
1. History of allergic reaction to fluticasone propionate, azelastine hydrochloride,
loratadine, or one of the excipients of the study treatments (e.g. benzalkonium
chloride, phenylethyl alcohol, microcrystalline cellulose) or a component of the
container.
2. History of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal,
haematological, endocrine, metabolic, psychiatric, neurological, or other disease at
screening that may affect subject safety during the study or evaluation of the study
endpoints at the discretion of the Investigator and/or designee.
3. Subjects with a current diagnosis of asthma or subjects with measured FEV1 <75% of the
predicted value.
4. Pregnant, breast-feeding or planning a pregnancy during the study and women of
childbearing potential not using adequate contraception. Women of childbearing
potential not abstinent or using a highly effective method of birth control defined as
those which result in a low failure rate (i.e. <1% per year) when used consistently
and correctly such as implants, injectables, combined oral contraceptives, hormonal
IUDs, tubal ligation or vasectomised partner started at least 4 weeks prior to
screening.
Lack of suitability for the study:
5. Previous and concomitant treatments: use of prohibited therapies (Antihistaminic
agents,Theophylline, Cromolyn sodium, Corticosteroids, Decongestants, Immunotherapy,
Systemic antibiotics, any cytochrome P450 3A4 inhibiting or inducing drug [e.g.
ritonavir, ketoconazole, itraconazole, erythromycin, cimetidine, rifampicin, St.
John's wort (Hypericum perforatum) etc.], Tricyclic antidepressants and MAO inhibitors
); and use of any medication considered to have an influence on the outcome of the
study during the EEC session, at the discretion of the Investigator and/or designee.
6. Subjects with (expected) clinically relevant symptoms at the timing of the scheduled
EEC assessments due to concomitant sensitization, i.e., positive SPT (mean wheal
diameter at least 3 mm larger than the negative control) and a history of allergic
response to the causative allergen, at the discretion of the Investigator. Subjects
with a positive SPT for cats and/or dogs are acceptable if the subject avoids cats
and/or dogs for the duration of the study.
7. Concomitant diseases: abnormalities during the screening visit that might interfere
with study results as determined by the Investigator and/or designee.
8. Presence of a severely deviated septum, septal perforation, structural nasal defect or
large nasal polyps causing obstruction as determined by the Investigator.
9. Acute conditions: any acute illness within 7 days prior to the screening visit,
including acute conjunctivitis or any other ocular infection.
10. History of increased ocular pressure, glaucoma and/or cataracts.
11. Tuberculosis, untreated local or systemic fungal or bacterial infections, systemic
viral or parasitic infections or ocular herpes simplex.
12. Recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, as judged by the
Investigator.
13. Exposure to chickenpox or measles within 4 weeks prior to the screening visit or
during the study.
14. History of chronic sinusitis or history of non-allergic rhinitis.
15. Exposure to another investigational product within the last 30 days prior to
screening.
16. History of malignancy within the past five years, except for basal cell skin
carcinomas that have been treated with no recurrence for at least 3 months.
17. Neurological or psychiatric disease or drug or alcohol abuse which would interfere
with the subject's proper completion of the protocol assignment. Subjects with a
positive urine drug screen will be excluded.
18. Subjects undergoing surgical procedures with general anaesthesia within 90 days prior
to screening or who plan to undergo surgery/hospitalization during the study.
Administrative reasons:
19. Vulnerable subjects (such as persons kept in detention).
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