Perennial Allergic RhinitisPhase 4NCT00439712
Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis
A Phase 4 study testing Levocetirizine in people with Perennial Allergic Rhinitis, run by Institut für Atemwegsforschung GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to show that in patients suffering from perennial allergic rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to investigate how relevant for these patients their nasal obstruction and the effect of levocetirizine on their nasal obstruction are. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to May 2007
- Phase
- Phase 4
- 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
- Age of 18 to 65 years (inclusively).
- Ability to understand nature, scope and possible consequences of the study.
- Capability and willingness to comply with the requirements of the protocol.
- Written informed consent was granted after in depth written and oral information on all relevant aspects of the study.
- Adequate contraception in case of females of child bearing potential (i.e. hormonal contraception, IUD, double barrier method, monogamous sexual relation with an monogamous partner, sexual inactivity).
- At least 2 year history of perennial allergic rhinitis with pronounced symptoms.
- Sensitization to D. farinae or D. pteronyssinus proved by a prick test (wheal diameter ≥ 3 mm) or measurement of specific IgE (at least RAST class 2) at most one year ago.
- On visit 2: Sum of the morning nasal obstruction scores documented in the screening diary is at least 40% of the maximal sum the patient could have attained.
Who cannot join
- Exposure to another investigational agent within the last three months.
- Pregnancy or nursing.
- Severe diseases and diseases, conditions or findings which might interfere with the study results, deteriorate due to study participation or require impermissible medication. In particular this includes
- restricted liver or kidney function or respectively creatinine clearance below 50 ml/min, the clearance being estimated according to the formula by Cockcroft/Gault from serum creatinine assessed on visit 1,
- nasal polyps, severe deviations of the nasal septum, and any other considerable impairments of nasal patency,
- an ear, nose or throat infection during the last 2 weeks or any other but allergic form of rhinitis,
Show all 13Show fewer
- asthma requiring any other treatment than short acting β-agonists on demand,
- atopic dermatitis with considerable probability to require corticosteroid treatment.
- Intake of impermissible medication or non observance of the designated washout periods.
- History of malignancy within the last 5 years.
- Drug or alcohol abuse.
- Intention to donate blood during the study period.
- Intolerance to one of the components of the trial medication.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Atemwegsforschung GmbH
Düsseldorf, North Rhine-Westphalia, 404597
About this study
Official title: Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis
The purpose of this study is to show that in patients suffering from perennial allergic rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to investigate how relevant for these patients their nasal obstruction and the effect of levocetirizine on their nasal obstruction are.
Read the detailed description
The study is performed according to a monocentre, double-blind, placebo controlled, two arm parallel group design. It is divided in 3 periods: A 7 ± 2 day screening phase when patients are not to treat their perennial allergic rhinitis (PAR) is followed by a 29 ± 4 day treatment period when patients administer either levocetirizine 5 mg OD or placebo and a 14 ± 2 week post treatment observation period when again medication against PAR is not to be taken. However in all study periods patients are provided cromoglicine nasal spray and eye drops which in case of severe complaints they may use as rescue medication.
Throughout the study patients keep a diary documenting the severity of their nasal and ocular symptoms of allergy. Every morning and every evening they use a 4-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe) to rate nasal obstruction, rhinorrhea, nasal itching, sneezing and ocular complaints they experienced during the preceding 12 hours. Furthermore they report adverse events and intake of drugs inclusive of rescue and (during treatment period) study medication.
Patients attend 5 visits to the study site. On visit 1 medical history and concomitant medication are assessed and patients undergo a physical examination, a pregnancy test in case of women of child bearing potential, and, if necessary, a skin prick test. Blood is taken to estimate creatinine clearance. Inclusion and exclusion criteria are checked and, if they do not contradict study continuation, patients enter the screening period which ends in the morning of the day visit 2. If on this visit morning diary reports show sufficiently high nasal obstruction scores and study participation still complies with the inclusion and exclusion criteria, patients are randomized and start the treatment period taking the first dose at the study site. On visit 2 as well as on the following visits adverse events and use of medication are surveyed and compliance is checked. Visit 3, 4 and 5 are scheduled after one week of treatment, between treatment and post treatment observation period and at the end of the study respectively. On visit 5 there is a final physical examination and again females of childbearing potential undergo a pregnancy test. To assess how relevant for patients nasal obstruction and the effect of the study medication on nasal obstruction are questionnaires are completed on each visit.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Levocetirizine, Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days
PlaceboDrug
1 placebo tablet OD in the morning for 29+/-4 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Not described Receives: Drug: Levocetirizine |
| Treatment Group 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average morning nasal obstruction score calculated from diary assessments during treatment.
Measured: 4 week treatment period
Secondary outcomes (7)
average morning and average evening single symptom score calculated from diary assessments during treatment period (with exception of the primary endpoint)
Measured: 4 week treatment period
average of the daily mean single symptom score (mean of morning and evening assessment) calculated with respect to diary assessments during treatment period
Measured: 4 week treatment period
average morning, evening and total T5SS calculated with respect to the treatment period
Measured: 4 week treatment period
average use of rescue medication (number of applications) during the treatment period
Measured: 4 week treatment period
differences between the preceding parameters and the respective averages calculated in regard to the follow-up period
Measured: 4 week treatment and 2 week follow-up period
results and changes in results of questionnaire 1
Measured: assessed on visits during the 7 week study period
results of questionnaires 2, 3 and 4
Measured: assessed on visits during the 4 week treatment and the 2 week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Atemwegsforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCB Pharma
- Investigators
- Claus Bachert, MD, PhD, Principal investigator, Institut für Atemwegsforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439712
- Sponsor's protocol ID
- Levo-6-06
- Status last verified
- Jan 2008
- First submitted
- 22 Feb 2007
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis
- ClinicalTrials.gov ID
- NCT00439712
- Acronym / sponsor ID
- Levo-6-06
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut für Atemwegsforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- UCB Pharma
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 26 Feb 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.
The purpose of this study is to show that in patients suffering from perennial allergic rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to investigate how relevant for these patients their nasal obstruction and the effect of levocetirizine on their nasal obstruction are.
Detailed description
The study is performed according to a monocentre, double-blind, placebo controlled, two arm parallel group design. It is divided in 3 periods: A 7 ± 2 day screening phase when patients are not to treat their perennial allergic rhinitis (PAR) is followed by a 29 ± 4 day treatment period when patients administer either levocetirizine 5 mg OD or placebo and a 14 ± 2 week post treatment observation period when again medication against PAR is not to be taken. However in all study periods patients are provided cromoglicine nasal spray and eye drops which in case of severe complaints they may use as rescue medication.
Throughout the study patients keep a diary documenting the severity of their nasal and ocular symptoms of allergy. Every morning and every evening they use a 4-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe) to rate nasal obstruction, rhinorrhea, nasal itching, sneezing and ocular complaints they experienced during the preceding 12 hours. Furthermore they report adverse events and intake of drugs inclusive of rescue and (during treatment period) study medication.
Patients attend 5 visits to the study site. On visit 1 medical history and concomitant medication are assessed and patients undergo a physical examination, a pregnancy test in case of women of child bearing potential, and, if necessary, a skin prick test. Blood is taken to estimate creatinine clearance. Inclusion and exclusion criteria are checked and, if they do not contradict study continuation, patients enter the screening period which ends in the morning of the day visit 2. If on this visit morning diary reports show sufficiently high nasal obstruction scores and study participation still complies with the inclusion and exclusion criteria, patients are randomized and start the treatment period taking the first dose at the study site. On visit 2 as well as on the following visits adverse events and use of medication are surveyed and compliance is checked. Visit 3, 4 and 5 are scheduled after one week of treatment, between treatment and post treatment observation period and at the end of the study respectively. On visit 5 there is a final physical examination and again females of childbearing potential undergo a pregnancy test. To assess how relevant for patients nasal obstruction and the effect of the study medication on nasal obstruction are questionnaires are completed on each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: Levocetirizine |
| Treatment Group 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age of 18 to 65 years (inclusively).
- Ability to understand nature, scope and possible consequences of the study.
- Capability and willingness to comply with the requirements of the protocol.
- Written informed consent was granted after in depth written and oral information on all relevant aspects of the study.
- Adequate contraception in case of females of child bearing potential (i.e. hormonal contraception, IUD, double barrier method, monogamous sexual relation with an monogamous partner, sexual inactivity).
Key exclusion criteria (13 listed)
- Exposure to another investigational agent within the last three months.
- Pregnancy or nursing.
- Severe diseases and diseases, conditions or findings which might interfere with the study results, deteriorate due to study participation or require impermissible medication. In particular this includes
- Intake of impermissible medication or non observance of the designated washout periods.
- History of malignancy within the last 5 years.
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 |
|---|---|---|
| Levocetirizine1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days | Drug | Treatment Group 1 |
| Placebo1 placebo tablet OD in the morning for 29+/-4 days | Drug | Treatment Group 2 |
Primary outcome
Average morning nasal obstruction score calculated from diary assessments during treatment.
Time frame: 4 week treatment period
7 secondary outcomes
average morning and average evening single symptom score calculated from diary assessments during treatment period (with exception of the primary endpoint)
Time frame: 4 week treatment period
average of the daily mean single symptom score (mean of morning and evening assessment) calculated with respect to diary assessments during treatment period
Time frame: 4 week treatment period
average morning, evening and total T5SS calculated with respect to the treatment period
Time frame: 4 week treatment period
average use of rescue medication (number of applications) during the treatment period
Time frame: 4 week treatment period
differences between the preceding parameters and the respective averages calculated in regard to the follow-up period
Time frame: 4 week treatment and 2 week follow-up period
results and changes in results of questionnaire 1
Time frame: assessed on visits during the 7 week study period
results of questionnaires 2, 3 and 4
Time frame: assessed on visits during the 4 week treatment and the 2 week follow-up period
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 15 Jan 2008.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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.
Claus Bachert, MD, PhD principal investigator
Institut für Atemwegsforschung GmbH
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 Levocetirizine in people with Perennial Allergic Rhinitis, run by Institut für Atemwegsforschung GmbH 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 13 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 15 Jan 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. 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?
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?
Average morning nasal obstruction score calculated from diary assessments during treatment. (time frame: 4 week treatment period). 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 15 Jan 2008.