The aim of this study is to assess the efficacy on nasal congestion and other allergic
symptoms and the onset of action of an oral combination of cetirizine and pseudoephedrine in
comparison to the single substances under controlled pollen exposure in an Environmental
Challenge Chamber (ECC).
Inclusion Criteria:
- Male and female subjects, aged 18-55 years. Women will be considered for inclusion if
they are:
Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing. Of non-child
bearing potential (i. e. physiologically incapable of becoming pregnant, including any
female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or
tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more
than 1 year prior to the screening visit).
Of childbearing potential and using a highly effective method of contraception during the
entire study (vasectomized partner, abstinence - the lifestyle of the female should be such
that there is complete abstinence from intercourse from two weeks prior to the first dose
of study medication and to continue until at least 72 hours after treatment - , implants,
injectables, combined oral contraceptives, some IUDs)
- FEV1 > 80% of predicted at screening.
- Absence of any structural nasal abnormalities or nasal polyps on examination, absence
of a history of frequent nose bleeding or recent nasal surgery.
- Absence of conditions or factors, which would make the subject unlikely to be able to
stay in the Fraunhofer ECC for 6 hours.
- Non smokers or smokers with a history of less than 10 pack years.
- Able and willing to give written informed consent to take part in the study.
- Available to complete all study measurements.
- History of allergic rhinitis to grass pollen and a positive skin prick test for
Dactylis glomerata pollen at or within 12 months prior to the screening visit.
- Subject must exhibit a moderate response upon 4000 Dactylis glomerata pollen grains/m3
during 2 hours in the ECC on visit 2.
- Subjects with mild stable asthma that is controlled with occasional use of as-needed
short-acting beta-agonists and associated with normal lung function may be included.
Exclusion Criteria:
- • History of a respiratory tract infection and/or exacerbation of asthma within 4
weeks before the screening and during the study.
- Any history of life-threatening asthma, defined as an asthma episode that
required intubation and/or was associated with hypercapnia, respiratory arrest or
hypoxic seizures.
- Administration of oral, injectable or dermal corticosteroids within 8 weeks or
intranasal and/or inhaled corticosteroids within 4 weeks of the screening visit.
- Unable to abstain from other medications including non-steroidal
anti-inflammatory drugs (NSAIDS), anti-depressant drugs, anti-histamines and
anti-asthma, anti-rhinitis or hay fever medication (other than short acting
inhaled beta-agonists) for 1 week prior to screening and throughout the course of
the study.
- Paracetamol up to 1g per day is permitted for the treatment of minor ailments,
e. g. headache.
- Past or present disease, which as judged by the investigator, may affect the
outcome of this study. These diseases include, but are not limited to,
cardiovascular disease, malignancy, hepatic disease, renal disease, hematological
disease, neurological disease, endocrine disease or pulmonary disease (including
but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis
or cystic fibrosis).
- Known hypersensitivity, allergic reactions or intolerance to cetirizine,
pseudoephedrine or any of the other ingredients.
- Subject receiving monoamine oxidase inhibitors or has received these agents in
the last two weeks before dosing.
- Subject is undergoing allergen desensitisation therapy.
- There is a risk of non-compliance with study procedures.
- Participation in another clinical trial 30 days prior to enrolment.
