Allergic RhinitisPhase 4NCT00826943
Is Levocetirizine Less Sedating Than Cetirizine?
A Phase 4 study testing Cetirizine and Levocetirizine in people with Allergic Rhinitis, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Cetirizine and Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 18 years of age or older
- patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:
- dust mite
- cat (if they own an indoor cat)
- dog (if they own an indoor dog)
- will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
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- history of reported sedation/somnolence when taking cetirizine
- patient must have taken cetirizine for at least 1 week prior to discontinuing it
- patients must have either tolerated levocetirizine in the past or have never tried levocetirizine.
Who cannot join
- chronic urticaria requiring ongoing antihistamine or steroid treatment
- atopic dermatitis requiring ongoing antihistamine or steroid treatment
- URI or sinus infection during the 2 weeks preceding the beginning of the study
- vasomotor (non-allergic) or irritant rhinitis
- afrin use
- elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency
Show all 11Show fewer
- patients who have not tolerated levocetirizine in the past due to sedation.
- taking other prescription or over the counter antihistamines and unwilling to stop them during the study
- the presence of a sleep disorder such as sleep apnea or narcolepsy
- the use of as needed sleeping aid medication
- the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Asthma, Sinus, and Allergy Clinic
Nashville, Tennessee, 37203
About this study
Official title: Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.
Read the detailed description
Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.
- Conditions
- Allergic Rhinitis
- Being tested
- Cetirizine, Levocetirizine, Placebo
- Keywords
- Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Cetirizine 10 mg tab daily x 7 days
LevocetirizineDrug
5 mg tab daily x 7 days
PlaceboDrug
Placebo tablet daily x 7 days
| Study group | Role | What they receive |
|---|---|---|
| Levocetirzine | Active comparator | 5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) Receives: Drug: Levocetirizine |
| cetirizine | Active comparator | 10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. Receives: Drug: Cetirizine |
| placebo | Placebo comparator | one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Epworth Sleepiness Scale
Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.
This was mean data for all interventions.
Measured: 36 days of the study
Likert Score Rating Global Sedation
Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.
This was mean data for all interventions.
Measured: duration of study (36 days)
Secondary outcomes (1)
Total Four Symptom Scores (Allergy Symptoms)
Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.
This was mean data for all interventions.
Measured: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Tzanetos, Vanderbilt University
- Investigators
- Douglas B Tzanetos, M.D., Principal investigator, Vanderbilt University Medical CenterJohn M Fahrenholz, M.D., Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826943
- Sponsor's protocol ID
- 080829
- Status last verified
- Feb 2014
- First submitted
- 20 Jan 2009
- Last updated
- 20 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Devalia JL, De Vos C, Hanotte F, Baltes E. A randomized, double-blind, crossover comparison among cetirizine, levocetirizine, and ucb 28557 on histamine-induced cutaneous responses in healthy adult volunteers. Allergy. 2001 Jan;56(1):50-7. doi: 10.1034/j.1398-9995.2001.00726.x.
PubMed 11167352de Blic J, Wahn U, Billard E, Alt R, Pujazon MC. Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Pediatr Allergy Immunol. 2005 May;16(3):267-75. doi: 10.1111/j.1399-3038.2005.00216.x.
PubMed 15853959Bachert C, Bousquet J, Canonica GW, Durham SR, Klimek L, Mullol J, Van Cauwenberge PB, Van Hammee G; XPERT Study Group. Levocetirizine improves quality of life and reduces costs in long-term management of persistent allergic rhinitis. J Allergy Clin Immunol. 2004 Oct;114(4):838-44. doi: 10.1016/j.jaci.2004.05.070.
PubMed 15480324
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00826943
- Acronym / sponsor ID
- 080829
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Posted 20 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.
Detailed description
Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levocetirzine | Active comparator | Drug: Levocetirizine5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) |
| cetirizine | Active comparator | Drug: Cetirizine10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. |
| placebo | Placebo comparator | Drug: Placeboone tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients 18 years of age or older
- patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:
- will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
- history of reported sedation/somnolence when taking cetirizine
- patient must have taken cetirizine for at least 1 week prior to discontinuing it
Key exclusion criteria (11 listed)
- chronic urticaria requiring ongoing antihistamine or steroid treatment
- atopic dermatitis requiring ongoing antihistamine or steroid treatment
- URI or sinus infection during the 2 weeks preceding the beginning of the study
- vasomotor (non-allergic) or irritant rhinitis
- afrin use
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 |
|---|---|---|
| CetirizineCetirizine 10 mg tab daily x 7 days | Drug | cetirizine |
| Levocetirizine5 mg tab daily x 7 days | Drug | Levocetirzine |
| PlaceboPlacebo tablet daily x 7 days | Drug | placebo |
Primary outcome
Modified Epworth Sleepiness Scale
Time frame: 36 days of the study
Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36. This was mean data for all interventions.
Likert Score Rating Global Sedation
Time frame: duration of study (36 days)
Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study. This was mean data for all interventions.
1 secondary outcome
Total Four Symptom Scores (Allergy Symptoms)
Time frame: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11167352Devalia JL, De Vos C, Hanotte F, Baltes E. A randomized, double-blind, crossover comparison among cetirizine, levocetirizine, and ucb 28557 on histamine-induced cutaneous responses in healthy adult volunteers. Allergy. 2001 Jan;56(1):50-7. doi: 10.1034/j.1398-9995.2001.00726.x.
- Background: PubMed 15853959de Blic J, Wahn U, Billard E, Alt R, Pujazon MC. Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Pediatr Allergy Immunol. 2005 May;16(3):267-75. doi: 10.1111/j.1399-3038.2005.00216.x.
- Background: PubMed 15480324Bachert C, Bousquet J, Canonica GW, Durham SR, Klimek L, Mullol J, Van Cauwenberge PB, Van Hammee G; XPERT Study Group. Levocetirizine improves quality of life and reduces costs in long-term management of persistent allergic rhinitis. J Allergy Clin Immunol. 2004 Oct;114(4):838-44. doi: 10.1016/j.jaci.2004.05.070.
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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.
Douglas B Tzanetos, M.D. principal investigator
Vanderbilt University Medical Center
John M Fahrenholz, M.D. study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetirizine and Levocetirizine in people with Allergic Rhinitis, run by Vanderbilt University at 1 site in United States.
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 9 inclusion and 11 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 20 Feb 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Epworth Sleepiness Scale (time frame: 36 days of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826943, which also lists 3 linked publications.
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 20 Feb 2014.