AtopyNCT00474890
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
A study testing cetericine and pseudoephedrine in people with Atopy and Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- cetericine and pseudoephedrine
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, 30625
About this 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
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.
Read the 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.
- Being tested
- cetericine and pseudoephedrine
- Keywords
- Seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetericine and pseudoephedrineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Norbert Krug, Professor, Principal investigator, Fraunhofer-Institute of Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474890
- Sponsor's protocol ID
- 07/03 Inopec ITEM
- Status last verified
- Feb 2008
- First submitted
- 15 May 2007
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Badorrek P, Dick M, Hecker H, Schaumann F, Sousa AR, Murdoch R, Hohlfeld JM, Krug N. Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season. Ann Allergy Asthma Immunol. 2011 Apr;106(4):336-41. doi: 10.1016/j.anai.2010.12.018. Epub 2011 Feb 5.
PubMed 21457883
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00474890
- Acronym / sponsor ID
- 07/03 Inopec ITEM
- Keywords
- Seasonal allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008
- First posted
- 17 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male and female subjects, aged 18-55 years. Women will be considered for inclusion if they are:
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetericine and pseudoephedrine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2008.
- Derived from this study: PubMed 21457883Badorrek P, Dick M, Hecker H, Schaumann F, Sousa AR, Murdoch R, Hohlfeld JM, Krug N. Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season. Ann Allergy Asthma Immunol. 2011 Apr;106(4):336-41. doi: 10.1016/j.anai.2010.12.018. Epub 2011 Feb 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Krug, Professor principal investigator
Fraunhofer-Institute of Toxicology and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cetericine and pseudoephedrine in people with Atopy and Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2008; AzTrials last refreshed its copy on 8 Nov 2026.