RhinitisPhase 2NCT00291642
A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
A Phase 2 study testing Levocetirizine drops and Levocetirizine tablets in people with Rhinitis and Allergic, run by UCB Pharma at 1 site in Canada.
Trial summary
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure… Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- Levocetirizine drops and Levocetirizine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 551 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2006to 1 Apr 2006
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol
Who cannot join
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Cetirizine 10 mg Oral Tablets to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
- Being tested
- Placebo drops, Placebo tablets matching to levocetirizine, Placebo tablets matching to cetirizine, Levocetirizine drops, Levocetirizine tablets
- Keywords
- Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo dropsDrug
- Pharmaceutical form: Drops for oral administration
- Route of administration: Oral use
Placebo tablets matching to levocetirizineDrug
- Pharmaceutical form: Tablets for oral administration
- Route of administration: Oral use
Placebo tablets matching to cetirizineDrug
- Pharmaceutical form: Tablets for oral administration
- Route of administration: Oral use
Levocetirizine dropsDrug
Also called Xyzal
- Pharmaceutical form: Drops for oral administration
- Concentration: 5 mg/ml
- Route of administration: Oral use
Levocetirizine tabletsDrug
Also called Xyzal
- Pharmaceutical form: Tablets for oral administration
- Concentration: 5 mg
- Route of administration: Oral use
Cetirizine dropsDrug
- Pharmaceutical form: Drops for oral administration
- Concentration: 10 mg/ml
- Route of administration: Oral use
Cetirizine tabletsDrug
- Pharmaceutical form: Tablets for oral administration
- Concentration: 10 mg
- Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Placebo (PBO) | Placebo comparator | A single dose of placebo was administered orally on Day 1. Receives: Drug: Placebo drops; Drug: Placebo tablets matching to levocetirizine; Drug: Placebo tablets matching to cetirizine |
| Levocetirizine (LCTZ) 2.5 mg | Experimental | A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. Receives: Drug: Levocetirizine drops |
| Levocetirizine (LCTZ) 5 mg | Experimental | A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. Receives: Drug: Levocetirizine tablets |
| Cetirizine (CTZ) 5 mg | Experimental | A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. Receives: Drug: Cetirizine drops |
| Cetirizine (CTZ) 10 mg | Experimental | A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. Receives: Drug: Cetirizine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:
Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Secondary outcomes (8)
Change From Baseline in the MSC Score Over Period II
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:
Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:
Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline to Day 2
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
The TSC score was calculated as the sum of the following 10 individual symptom scores:
runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
The TSC score was calculated as the sum of the following 10 individual symptom scores:
runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
The TSC score was calculated as the sum of the following 10 individual symptom scores:
runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.
Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline to Day 2
Change From Baseline in the Individual Symptom Scores Over Period I
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Change From Baseline in the Individual Symptom Scores Over Period II
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.
The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).
For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study start1 Jan 2006
- Primary completion1 Apr 2006
- Study completion1 Apr 2006
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.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, UCB (+1 844 599 2273)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291642
- Sponsor's protocol ID
- A00412
- Status last verified
- 1 Aug 2018
- First submitted
- 10 Feb 2006
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Cetirizine 10 mg Oral Tablets to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
- ClinicalTrials.gov ID
- NCT00291642
- Acronym / sponsor ID
- A00412
- Keywords
- Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2006
- Primary completion
- 1 Apr 2006 (actual)
- Study completion
- 1 Apr 2006 (actual)
- First posted
- 14 Feb 2006 (estimated)
- Results
- Posted 20 Jul 2018
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 the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo (PBO) | Placebo comparator | Drug: Placebo drops, Drug: Placebo tablets matching to levocetirizine, Drug: Placebo tablets matching to cetirizineA single dose of placebo was administered orally on Day 1. |
| Levocetirizine (LCTZ) 2.5 mg | Experimental | Drug: Levocetirizine dropsA single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. |
| Levocetirizine (LCTZ) 5 mg | Experimental | Drug: Levocetirizine tabletsA single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. |
| Cetirizine (CTZ) 5 mg | Experimental | Drug: Cetirizine dropsA single dose of 5 mg of CTZ oral drops was administered orally on Day 1. |
| Cetirizine (CTZ) 10 mg | Experimental | Drug: Cetirizine tabletsA single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol
Key exclusion criteria (2 listed)
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
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 |
|---|---|---|
| Placebo drops* Pharmaceutical form: Drops for oral administration * Route of administration: Oral use | Drug | Placebo (PBO) |
| Placebo tablets matching to levocetirizine* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use | Drug | Placebo (PBO) |
| Placebo tablets matching to cetirizine* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use | Drug | Placebo (PBO) |
| Levocetirizine dropsAlso: Xyzal* Pharmaceutical form: Drops for oral administration * Concentration: 5 mg/ml * Route of administration: Oral use | Drug | Levocetirizine (LCTZ) 2.5 mg |
| Levocetirizine tabletsAlso: Xyzal* Pharmaceutical form: Tablets for oral administration * Concentration: 5 mg * Route of administration: Oral use | Drug | Levocetirizine (LCTZ) 5 mg |
| Cetirizine drops* Pharmaceutical form: Drops for oral administration * Concentration: 10 mg/ml * Route of administration: Oral use | Drug | Cetirizine (CTZ) 5 mg |
| Cetirizine tablets* Pharmaceutical form: Tablets for oral administration * Concentration: 10 mg * Route of administration: Oral use | Drug | Cetirizine (CTZ) 10 mg |
Primary outcome
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
Time frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
8 secondary outcomes
Change From Baseline in the MSC Score Over Period II
Time frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
Time frame: Baseline to Day 2
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
Time frame: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
Time frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
Time frame: Baseline to Day 2
Change From Baseline in the Individual Symptom Scores Over Period I
Time frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Change From Baseline in the Individual Symptom Scores Over Period II
Time frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
Time frame: Baseline to Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Cares study director
UCB (+1 844 599 2273)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levocetirizine drops and Levocetirizine tablets in people with Rhinitis and Allergic, run by UCB Pharma at 1 site in Canada.
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 3 inclusion and 2 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 11 Sep 2018. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jul 2018). 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?
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I (time frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]). 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 11 Sep 2018.