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| Sponsors and Collaborators: |
Fraunhofer-Institute of Toxicology and Experimental Medicine GlaxoSmithKline |
|---|---|
| Information provided by: | Fraunhofer-Institute of Toxicology and Experimental Medicine |
| ClinicalTrials.gov Identifier: | NCT00334698 |
Purpose
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 |
|---|---|
|
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) |
Eligibility| 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.
Contacts and Locations| Germany | |
| Fraunhofer-Institute of Toxicology and Experimental Medicine | |
| Hannover, Germany, 30623 | |
| Principal Investigator: | Prof. Norbert Krug, MD | Fraunhofer Institute of Toxikology and Experimental Medicine |
More Information
| Study ID Numbers: | 06/02 Nacon ITEM |
| Study First Received: | June 7, 2006 |
| Last Updated: | May 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00334698 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Neurotransmitter Agents Adrenergic Agents Rhinitis Nasal Decongestants Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Phenylephrine Vasoconstrictor Agents Pseudoephedrine Otorhinolaryngologic Diseases Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents |
Anti-Allergic Agents Cetirizine Histamine Oxymetazoline Histamine Antagonists Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists Ephedrine Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Rhinitis Nasal Decongestants Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Vasoconstrictor Agents Pseudoephedrine Otorhinolaryngologic Diseases Immune System Diseases |
Sympathomimetics Histamine Agents Anti-Asthmatic Agents Central Nervous System Stimulants Anti-Allergic Agents Cardiovascular Agents Cetirizine Nose Diseases Pharmacologic Actions Histamine Antagonists Autonomic Agents Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Ephedrine |