Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Fraunhofer-Institute of Toxicology and Experimental Medicine |
---|---|
Information provided by: | Fraunhofer-Institute of Toxicology and Experimental Medicine |
ClinicalTrials.gov Identifier: | NCT00474890 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female subjects, aged 18-55 years. Women will be considered for inclusion if they are:
Exclusion Criteria:
Germany | |
Fraunhofer Institute for Toxicology and Experimental Medicine | |
Hannover, Germany, 30625 |
Principal Investigator: | Norbert Krug, Professor | Fraunhofer-Institute of Toxicology and Experimental Medicine |
Study ID Numbers: | 07/03 Inopec ITEM |
Study First Received: | May 15, 2007 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00474890 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Seasonal allergic rhinitis |
Pseudoephedrine Otorhinolaryngologic Diseases Rhinitis Cetirizine Naphazoline Oxymetazoline Respiratory Tract Diseases |
Respiratory Tract Infections Phenylephrine Guaifenesin Rhinitis, Allergic, Seasonal Ephedrine Phenylpropanolamine |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Physiological Effects of Drugs Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents |
Nose Diseases Pharmacologic Actions Nasal Decongestants Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |