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

This study has been completed.
Sponsor:
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00474890
First received: May 15, 2007
Last updated: February 12, 2008
Last verified: February 2008
  Purpose

A previous study has shown very clearly that the treatment with the combination of cetirizine and pseudoephedrine is superior to the treatment with the single agents regarding the reduction of symptoms in patients with allergic rhinitis. These data, obtained after controlled pollen exposure out of the pollen season, showed highly reproducible individual responses prior to dosing. It is not clear, however, whether the same results can be obtained during the pollen season, when additional natural pollen exposure may influence the variability of the individual reactions.


Condition Intervention
Atopy
Rhinitis
Drug: cetericine and pseudoephedrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Estimated Enrollment: 70
Study Start Date: June 2007
Estimated Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The aim of this study is to evaluate prospectively, if reproducible results can be shown when testing a combination of cetirizine and pseudoephedrine in an Environmental Exposure Unit setting once inside and once outside the grass pollen season. An equivalent outcome would validate the ECC for testing anti-allergic substances during the pollen season in the future. Up to now these studies have been restricted to the pollen-free season.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474890

Locations
Germany
Fraunhofer Institute for Toxicology and Experimental Medicine
Hannover, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Investigators
Principal Investigator: Norbert Krug, Professor Fraunhofer-Institute of Toxicology and Experimental Medicine
  More Information

No publications provided by Fraunhofer-Institute of Toxicology and Experimental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00474890     History of Changes
Other Study ID Numbers: 07/03 Inopec ITEM
Study First Received: May 15, 2007
Last Updated: February 12, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:
Seasonal allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pseudoephedrine
Ephedrine
Cetirizine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014