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Sponsors and Collaborators: |
Fraunhofer-Institute of Toxicology and Experimental Medicine GlaxoSmithKline |
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Information provided by: | Fraunhofer-Institute of Toxicology and Experimental Medicine |
ClinicalTrials.gov Identifier: | NCT00334698 |
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 | Intervention |
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Seasonal Allergic Rhinitis |
Drug: cetirizine (drug) Drug: pseudoephedrine (drug) Drug: cetirizine with pseudoephedrine (drug) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
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) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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)
Exclusion Criteria:
• History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening and during the study.
Germany | |
Fraunhofer-Institute of Toxicology and Experimental Medicine | |
Hannover, Germany, 30623 |
Principal Investigator: | Prof. Norbert Krug, MD | Fraunhofer Institute of Toxikology and Experimental Medicine |
Study ID Numbers: | 06/02 Nacon ITEM |
Study First Received: | June 7, 2006 |
Last Updated: | May 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00334698 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Pseudoephedrine Otorhinolaryngologic Diseases Rhinitis Cetirizine Histamine Naphazoline Oxymetazoline Hypersensitivity Respiratory Tract Diseases |
Respiratory Tract Infections Guaifenesin Phenylephrine Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Ephedrine Phenylpropanolamine Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Immune System Diseases Sympathomimetics Physiological Effects of Drugs Histamine Agents Anti-Asthmatic Agents Central Nervous System Stimulants Anti-Allergic Agents Cardiovascular Agents |
Nose Diseases Pharmacologic Actions Nasal Decongestants Histamine Antagonists Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Histamine H1 Antagonists Peripheral Nervous System Agents Histamine H1 Antagonists, Non-Sedating Central Nervous System Agents Bronchodilator Agents |