Allergic RhinitisPhase 3LevoNasalFloNCT01000792
3-D Visualization of the Anti-Obstructive Effect of Levocetirizine
A Phase 3 study testing Levocetirizine in people with Allergic Rhinitis, run by Clinical Research International Limited at 1 site in Germany.
Trial summary
The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it is important and necessary to understand and visualize therapy effects on this disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jul 2010
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be informed and give written informed consent for study participation
- Subject must be able to adhere to dose and visit schedules and meet study requirements
- Subject must be aged 18 to 65 (inclusive); gender and race are irrelevant
- Subject must have at least a two-year history of allergic rhinitis consistent with persistent allergic rhinitis (defined as symptoms of allergic rhinitis present on four days or more per week or for four or more consecutive weeks per year)
- In the previous pollen season, subject must have been sufficiently symptomatic, with a T6SS (reflective) symptoms severity score of at least 10 (out of max. 18). (Symptoms include nasal itching, sneezing, rhinorrhea, congestion, conjunctival itching, redness and tearing graded on a scale of 0 -absent, 1 - mild, 2 - moderate, 3 - severe)
- Subject must have a positive skin prick test at screening to one or more allergens in the local panel of seasonal allergens (e.g. grass, tree pollen), but not to perennial allergens. Subject must demonstrate an antigen-induced skin prick wheal of at least 3mm greater in diameter than the diluent control.
- Subject must have had a positive nasal allergen challenge within the previous six months. (see [Riechelmann])
- Nonsterile or premenopausal female subjects must use a medically accepted method of birth control, e.g. oral contraceptives
Who cannot join
- Failure to fulfill all of the above mentioned inclusion criteria
- Insufficient ability to understand the nature, scope and possible consequences of the study
- Insufficient legal competence or insufficient knowledge of the German language
- Participation in another clinical trial within the previous three months
- Pregnancy or lactation
- Positive skin prick test to frequently occurring perennial allergens, e.g. house dust mites, cats
Show all 15Show fewer
- History of anaphylaxis and/or severe local reactions to skin testing with allergens
- Intolerable symptoms that would make participating in the study unbearable, especially the 45 min MRI-session
- Any viral inflammation of the upper respiratory system, acute or chronic sinusitis, rhinitis medicamentosa, nasal polyps, clinically relevant anatomic deviations of the nose, active or inactive tuberculosis of the respiratory tract, or asthma other than mild intermittent asthma treated with ß2-agonists on an as-needed basis
- Any kind of clinically significant disease, especially any signs of active persistent allergic rhinitis, which would interfere with the study evaluations.
- Known intolerance to levocetirizine or any other components of the study drugs
- Surgery of the nose or the nasal sinuses within the previous six months
- Any deviation from the norm in the physical investigation of any disease which in the investigator's judgment might require impermissible medication, influence study performance and results or affect the patients safety
- Intake of drugs which might interfere with the study results
- History of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
HNO-Praxis Dr. Pasch/Prof. Schlöndorff
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 3-D Visualization of the Anti-Obstructive Effect of Levocetirizine - A Monocentric Clinical Trail With One Patient (Phase-IV-Study)
The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it is important and necessary to understand and visualize therapy effects on this disease. In this study we will demonstrate the effect of levocetirizine on nasal cavity dimensions by assessing not only standard nasal flow diagnostics such as rhinomanometry and acoustic rhinometry, but supplement exami¬nation procedures with long-term rhinometry and magnetic resonance imaging (MRI). With the aid of a virtual model and computer fluid dynamics, we are able to simulate nasal air flow and provide three-dimensional visualization of the computed flow.
In previous trials ([Bachert], [deBlic], [Day] and [Deruaz]) it has been shown that allergic symptoms, especially nasal congestion, diminish significantly under treatment with levocetirizine. We will demonstrate this anti-obstructive effect by comparing the reaction to nasal allergen challenge before and after four-week treatment with levocetirizine.
- Conditions
- Allergic Rhinitis
- Being tested
- Levocetirizine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
The study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride). 28 film tablets will be dispensed. Oral intake should be performed once daily (administration in the evening).
LevocetirizineDrug
Levocetirizine
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine | Experimental | Levo 5 mg o.d. Receives: Drug: Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of nasal flow
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph Mösges, M.D., Principal investigator, CRI-Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000792
- Sponsor's protocol ID
- CRI-2009-09-001-IV
- Acronym
- LevoNasalFlo
- Status last verified
- Jun 2011
- First submitted
- 22 Oct 2009
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-D Visualization of the Anti-Obstructive Effect of Levocetirizine - A Monocentric Clinical Trail With One Patient (Phase-IV-Study)
- ClinicalTrials.gov ID
- NCT01000792
- Acronym / sponsor ID
- LevoNasalFlo / CRI-2009-09-001-IV
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Clinical Research International LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Oct 2009 (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.
The prevalence of allergic rhinitis is high and appears to be rising worldwide. Therefore, it is important and necessary to understand and visualize therapy effects on this disease. In this study we will demonstrate the effect of levocetirizine on nasal cavity dimensions by assessing not only standard nasal flow diagnostics such as rhinomanometry and acoustic rhinometry, but supplement exami¬nation procedures with long-term rhinometry and magnetic resonance imaging (MRI). With the aid of a virtual model and computer fluid dynamics, we are able to simulate nasal air flow and provide three-dimensional visualization of the computed flow.
In previous trials ([Bachert], [deBlic], [Day] and [Deruaz]) it has been shown that allergic symptoms, especially nasal congestion, diminish significantly under treatment with levocetirizine. We will demonstrate this anti-obstructive effect by comparing the reaction to nasal allergen challenge before and after four-week treatment with levocetirizine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine | Experimental | Drug: LevocetirizineLevo 5 mg o.d. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must be informed and give written informed consent for study participation
- Subject must be able to adhere to dose and visit schedules and meet study requirements
- Subject must be aged 18 to 65 (inclusive); gender and race are irrelevant
- Subject must have at least a two-year history of allergic rhinitis consistent with persistent allergic rhinitis (defined as symptoms of allergic rhinitis present on four days or more per week or for four or more consecutive weeks per year)
- In the previous pollen season, subject must have been sufficiently symptomatic, with a T6SS (reflective) symptoms severity score of at least 10 (out of max. 18). (Symptoms include nasal itching, sneezing, rhinorrhea, congestion, conjunctival itching, redness and tearing graded on a scale of 0 -absent, 1 - mild, 2 - moderate, 3 - severe)
Key exclusion criteria (15 listed)
- Failure to fulfill all of the above mentioned inclusion criteria
- Insufficient ability to understand the nature, scope and possible consequences of the study
- Insufficient legal competence or insufficient knowledge of the German language
- Participation in another clinical trial within the previous three months
- Pregnancy or lactation
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 |
|---|---|---|
| LevocetirizineThe study drug is Xyzal® 5 mg (API: levocetirizine dihydrochloride). 28 film tablets will be dispensed. Oral intake should be performed once daily (administration in the evening). | Drug | Levocetirizine |
| LevocetirizineLevocetirizine | Drug | Levocetirizine |
Primary outcome
Improvement of nasal flow
Time frame: 4 weeks
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 22 Jun 2011.
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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.
Ralph Mösges, M.D. principal investigator
CRI-Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levocetirizine in people with Allergic Rhinitis, run by Clinical Research International Limited 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 8 inclusion and 15 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 22 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Improvement of nasal flow (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2011.