Study to Compare the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Placebo on Symptoms in Patients With Allergic Rhinitis Within/Out of Season

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00474890
• Date of registration: 15/05/2007
• Primary sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
• Public title: Study to Compare the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Placebo on Symptoms in Patients With Allergic Rhinitis Within/Out of Season
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy's Reproducibility of a Combination of Pseudoephedrine and Cetirizine on Symptom Scores and Rhinomanometry in Patients With Allergic Rhinitis Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC) in- and Outside the Grass Pollen Season
• Date of first enrolment: June 2007
• Target sample size: 70
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00474890
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Norbert Krug, Professor
• Affiliation: Fraunhofer-Institute of Toxicology and Experimental Medicine

Key inclusion & exclusion criteria

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 (vasectomised 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 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.

- 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.

- Able and willing to give written informed consent to take part in the study.

- Available to complete all study measurements.

Exclusion Criteria:

- Subjects showing clinical symptoms of perennial allergic rhinitis.

- History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks
before the screening.

- Any history of life-threatening asthma, defined as an asthma episode that required
intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic
seizures.

- Administration of oral, injectable or dermal corticosteroids within 8 weeks or
intranasal and/or inhaled corticosteroids 4 weeks prior to the screening visit.

- 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.

- Specific Immunotherapy (SIT) within the last two years prior to screening.

- There is a risk of non-compliance with study procedures.

- Participation in another clinical trial 30 days prior to enrolment.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Atopy

Rhinitis

Intervention(s)

Drug: cetericine and pseudoephedrine

Secondary ID(s)

07/03 Inopec ITEM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors