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Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms in Patients With Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00334698
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : February 3, 2010
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Cetirizine Drug: Pseudoephedrine Drug: Cetirizine with Pseudoephedrine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled, Four Way Cross-over Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms Scores and Rhinomanometry in Patients With Allergic Rhinitis Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC)
Study Start Date : July 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change of nasal obstruction symptom score


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334698


Locations
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Germany
Fraunhofer-Institute of Toxicology and Experimental Medicine
Hannover, Germany, 30623
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
GlaxoSmithKline
Investigators
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Principal Investigator: Prof. Norbert Krug, MD Fraunhofer Institute of Toxikology and Experimental Medicine

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ClinicalTrials.gov Identifier: NCT00334698     History of Changes
Other Study ID Numbers: 06/02 Nacon ITEM
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: May 2007

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Pseudoephedrine
Ephedrine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists