Allergic RhinitisPhase 4NCT00355771
Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis
A Phase 4 study testing Levocetirizine in people with Allergic Rhinitis, run by Institut für Atemwegsforschung GmbH at 1 site in China.
Trial summary
The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and sleep impairment due to this condition. Read more about this study
- Who is it for?
- Ages 18 to 50 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?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2006to Nov 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who demonstrate their willingness to participate in the study and to comply with its procedures by signing a written informed consent.
- Subjects aged between 18 and 50 years (inclusively), of either sex and any race.
- Women of childbearing potential have to use an acceptable method of birth control.
- Subjects have to be able to understand and to adhere to the dosing and visit schedules, and to agree to record symptom scores, NPIF measurements, adverse events, concomitant medications and intake of rescue medication accurately and consistently in a daily diary.
- Subjects have to suffer from symptoms of allergic rhinitis on more than 4 days a week and for more than 4 weeks per year (ARIA criteria).
- History of at least two years of persistent allergic rhinitis (as defined by ARIA criteria).
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- T5SS (Total Five Symptom Score, sum of scores evaluating the severity of five symptoms of rhinoconjunctivitis) assessed on visit 1 is > 8; in particular, nasal obstruction is rated ≥ 2.
- A CAP or prick test obtained within 12 months before visit 1 demonstrating sensitization to one or more allergens which anticipate symptoms of persistent allergic rhinitis on at least 4 days per week during the treatment period.
- On visit 2: Average T5SS calculated from diary reports is > 8 during the screening period; average rating of nasal obstruction is ≥ 2.
Who cannot join
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications.
- Subjects unable to understand the nature, scope, and possible consequences of the study or being suspected of non-compliance.
- Subjects who have used any investigational product within 30 days prior to enrollment or any investigational antibodies for asthma or allergic rhinitis in the past 90 days.
- History of alcohol or drug abuse.
- Any disease of the upper and lower respiratory tract except for allergic rhinitis during the last 2 weeks before visit 1, 2 and 3; any significant impairment of nasal patency.
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- Subjects with current evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease; or a tumor or conditions which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
- Any deviation from normal in physical examination and any disease (except for allergic rhinoconjunctivitis), which might deteriorate significantly due to the subject's participation, or require impermissible medication or interfere with study evaluation.
- History of hypersensitivity to the study drug or its excipients.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of ORL, West China Hospital, Sichuan Hospital
Chengdu, Sichuan, 610041
About this study
Official title: Placebo Controlled Pilot Study on the Efficacy of Levocetirizine 5 mg in Reducing Symptoms, Airway Resistance, and Sleep Impairment in Patients With Persistent Allergic Rhinitis
The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and sleep impairment due to this condition.
Read the detailed description
Levocetirizine 5 mg is well established as the treatment of seasonal and perennial rhinoconjunctivitis. This study has been designed, to investigate its efficacy in patients suffering from persistent allergic rhinitis as defined by the ARIA (Allergic Rhinitis and its Impact on Asthma) working group of the WHO.
The study is divided in an 8 ± 2 day screening and a 56 ± 3 day treatment phase. During both periods patients keep a diary reporting on the severity of their nasal and ocular complaints, the use of rescue medication (cromoglycate eye drops and nasal spray), other concomitant medication and adverse events. They apply a 0 to 3 point score (0 = no, 1= mild, 2 = moderate, 3 = severe symptoms) to rate nasal obstruction, rhinorrhea, nasal itching, sneezing and ocular symptoms in regard to their experience during the preceding 24 hours. During the treatment period they additionally report the time of intake of study medication and their assessments of their nasal peak inspiratory flow (NPIF). NPIF is measured every evening before symptom scoring and additionally before each intake of rescue nasal spray. A device similar to the peak flow meters employed for monitoring bronchial asthma is used. Before the treatment period in its middle and at its end patients undergo a polysomnography. Furthermore 2 weeks after the start of treatment and at its end patients and investigators employ a 5-step scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5= not at all effective) to assess the efficacy of the study medication.
Efficacy is to be established by comparison of a levocetirizine and a placebo treated group.
- Conditions
- Allergic Rhinitis
- Being tested
- Levocetirizine, Placebo
- Keywords
- allergic rhinitis, histamine antagonist, sleep disorder
- Medical subject headings
- Rhinitis, Allergic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks
PlaceboDrug
1 tablet OD in the morning for 8 weeks
| 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 T5SS calculated with respect to the 8 week treatment period. T5SS is the daily sum of 4-step symptom scores, which patients use to report the severity of five symptoms of allergic rhinoconjunctivitis in their diaries.
Measured: 8 week treatment period
Secondary outcomes (5)
Average of the individual symptom scores
Measured: 8 week treatment period
average daily NPIF
Measured: 8 week treatment period
average use of rescue medication
Measured: 8 week treatment period
sleep quality parameters assessed by polysomnography
Measured: in the beginning and after 6 to 8 weeks of treatment
global valuation of the efficacy
Measured: after 4 and 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2007
- Study completionNov 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355771
- Sponsor's protocol ID
- 1-1-2005
- Status last verified
- Jan 2008
- First submitted
- 24 Jul 2006
- 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
- Placebo Controlled Pilot Study on the Efficacy of Levocetirizine 5 mg in Reducing Symptoms, Airway Resistance, and Sleep Impairment in Patients With Persistent Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00355771
- Acronym / sponsor ID
- 1-1-2005
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, histamine antagonist, sleep disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut für Atemwegsforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- UCB Pharma
- Study start
- Jun 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 Jul 2006 (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 investigate, whether levocetirizine 5 mg relieves nasal and ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and sleep impairment due to this condition.
Detailed description
Levocetirizine 5 mg is well established as the treatment of seasonal and perennial rhinoconjunctivitis. This study has been designed, to investigate its efficacy in patients suffering from persistent allergic rhinitis as defined by the ARIA (Allergic Rhinitis and its Impact on Asthma) working group of the WHO.
The study is divided in an 8 ± 2 day screening and a 56 ± 3 day treatment phase. During both periods patients keep a diary reporting on the severity of their nasal and ocular complaints, the use of rescue medication (cromoglycate eye drops and nasal spray), other concomitant medication and adverse events. They apply a 0 to 3 point score (0 = no, 1= mild, 2 = moderate, 3 = severe symptoms) to rate nasal obstruction, rhinorrhea, nasal itching, sneezing and ocular symptoms in regard to their experience during the preceding 24 hours. During the treatment period they additionally report the time of intake of study medication and their assessments of their nasal peak inspiratory flow (NPIF). NPIF is measured every evening before symptom scoring and additionally before each intake of rescue nasal spray. A device similar to the peak flow meters employed for monitoring bronchial asthma is used. Before the treatment period in its middle and at its end patients undergo a polysomnography. Furthermore 2 weeks after the start of treatment and at its end patients and investigators employ a 5-step scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5= not at all effective) to assess the efficacy of the study medication.
Efficacy is to be established by comparison of a levocetirizine and a placebo treated group.
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 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects who demonstrate their willingness to participate in the study and to comply with its procedures by signing a written informed consent.
- Subjects aged between 18 and 50 years (inclusively), of either sex and any race.
- Women of childbearing potential have to use an acceptable method of birth control.
- Subjects have to be able to understand and to adhere to the dosing and visit schedules, and to agree to record symptom scores, NPIF measurements, adverse events, concomitant medications and intake of rescue medication accurately and consistently in a daily diary.
- Subjects have to suffer from symptoms of allergic rhinitis on more than 4 days a week and for more than 4 weeks per year (ARIA criteria).
Key exclusion criteria (9 listed)
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications.
- Subjects unable to understand the nature, scope, and possible consequences of the study or being suspected of non-compliance.
- Subjects who have used any investigational product within 30 days prior to enrollment or any investigational antibodies for asthma or allergic rhinitis in the past 90 days.
- History of alcohol or drug abuse.
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 |
|---|---|---|
| LevocetirizineIntake of 1 tablet of Levocetirizine 5mg OD for 8 weeks | Drug | Treatment Group 1 |
| Placebo1 tablet OD in the morning for 8 weeks | Drug | Treatment Group 2 |
Primary outcome
Average T5SS calculated with respect to the 8 week treatment period. T5SS is the daily sum of 4-step symptom scores, which patients use to report the severity of five symptoms of allergic rhinoconjunctivitis in their diaries.
Time frame: 8 week treatment period
5 secondary outcomes
Average of the individual symptom scores
Time frame: 8 week treatment period
average daily NPIF
Time frame: 8 week treatment period
average use of rescue medication
Time frame: 8 week treatment period
sleep quality parameters assessed by polysomnography
Time frame: in the beginning and after 6 to 8 weeks of treatment
global valuation of the efficacy
Time frame: after 4 and 8 weeks of treatment
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.
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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.
Claus Bachert, MD, PhD principal investigator
Institut für Atemwegsforschung
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 Allergic Rhinitis, run by Institut für Atemwegsforschung GmbH at 1 site in China.
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 9 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 China. 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 T5SS calculated with respect to the 8 week treatment period. T5SS is the daily sum of 4-step symptom scores, which patients use to report the severity of five symptoms of allergic rhinoconjunctivitis in their diaries. (time frame: 8 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.