Rhinitis, Allergic, SeasonalPhase 4NCT00295022
Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
A Phase 4 study testing Montelukast and Levocetirizine in people with Rhinitis, Allergic, Seasonal, run by UCB S.A. - Pharma Sector at 1 site in Canada.
Trial summary
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Montelukast and Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2006to 1 Oct 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the 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, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Placebo, Montelukast, Levocetirizine
- Keywords
- Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
- Pharmaceutical form: Over-encapsulated tablet
- Route of administration: Oral use
MontelukastDrug
- Pharmaceutical form: Over-encapsulated tablet
- Concentration: 10 mg
- Route of administration: Oral use
LevocetirizineDrug
- Pharmaceutical form: Over-encapsulated tablet
- Concentration: 5 mg
- Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Placebo (PBO) | Placebo comparator | Placebo was administered orally on Days 1 and 2. Receives: Drug: Placebo |
| Montelukast (MLKT) | Experimental | 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. Receives: Drug: Montelukast |
| Levocetirizine (LCTZ) | Experimental | 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. Receives: Drug: Levocetirizine |
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 (25)
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, from 9:30 am to 11:00 am]
Change From Baseline in the MSC Score Over Period III
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 III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
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 1 [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, from 9:30 am to 11:00 am]
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
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 III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
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 TSC Score + Nasal Congestion 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. 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 TSC Score + Nasal Congestion 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. 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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.
The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.
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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.
The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Change From Baseline in the Individual Symptom Scores Over Period III
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.
The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)
Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.
The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.
Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Measured: Baseline to Day 2
Time to First Feeling of Improvement During Period I
During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).
Measured: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Onset of Action During Period I
The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.
Measured: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intensity of Action From Baseline in the MSC Score Over Period I
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
Measured: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intensity of Action From Baseline in the MSC Score Over Period II
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
Measured: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Intensity of Action From Baseline in the MSC Score Over Period III
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
Measured: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Variability of Action From Baseline in the MSC Score Over Period I
The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:
< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.
Measured: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Variability of Action From Baseline in the MSC Score Over Period II
The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:
< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.
Measured: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Variability of Action From Baseline in the MSC Score Over Period III
The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:
< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.
Measured: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Global Satisfaction of the Subjects at the End of Period III
Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).
Measured: At the end of Period III (Day 2)
Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: "Do you want to take the same treatment during the next pollen season?" (yes or no).
Measured: At the end of Period III (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study start29 Jul 2006
- Primary completion1 Oct 2006
- Study completion1 Oct 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 Rhinitis, Allergic, SeasonalStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB S.A. - Pharma Sector
- 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
- NCT00295022
- Sponsor's protocol ID
- A00414
- Status last verified
- Aug 2018
- First submitted
- 20 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, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg 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
- NCT00295022
- Acronym / sponsor ID
- A00414
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Levocetirizine, Xyzal, Rhinitis, Allergic, Seasonal, Ragweed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- UCB S.A. - Pharma SectorIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2006
- Primary completion
- 1 Oct 2006 (actual)
- Study completion
- 1 Oct 2006 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (PBO) | Placebo comparator | Drug: PlaceboPlacebo was administered orally on Days 1 and 2. |
| Montelukast (MLKT) | Experimental | Drug: Montelukast10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. |
| Levocetirizine (LCTZ) | Experimental | Drug: Levocetirizine5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the 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* Pharmaceutical form: Over-encapsulated tablet * Route of administration: Oral use | Drug | Placebo (PBO) |
| Montelukast* Pharmaceutical form: Over-encapsulated tablet * Concentration: 10 mg * Route of administration: Oral use | Drug | Montelukast (MLKT) |
| Levocetirizine* Pharmaceutical form: Over-encapsulated tablet * Concentration: 5 mg * Route of administration: Oral use | Drug | Levocetirizine (LCTZ) |
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.
25 secondary outcomes
Change From Baseline in the MSC Score Over Period II
Time frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Change From Baseline in the MSC Score Over Period III
Time frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
Time frame: Baseline to Day 2
Change From Baseline in the Total Symptom Complex (TSC) 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)]
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
Time frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
Time frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
Time frame: Baseline to Day 2
Change From Baseline in the TSC Score + Nasal Congestion 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)]
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II
Time frame: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
Time frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
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, from 9:30 am to 11:00 am]
Change From Baseline in the Individual Symptom Scores Over Period III
Time frame: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)
Time frame: Baseline to Day 2
Time to First Feeling of Improvement During Period I
Time frame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Onset of Action During Period I
Time frame: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intensity of Action From Baseline in the MSC Score Over Period I
Time frame: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intensity of Action From Baseline in the MSC Score Over Period II
Time frame: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Intensity of Action From Baseline in the MSC Score Over Period III
Time frame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Variability of Action From Baseline in the MSC Score Over Period I
Time frame: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Variability of Action From Baseline in the MSC Score Over Period II
Time frame: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Variability of Action From Baseline in the MSC Score Over Period III
Time frame: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Global Satisfaction of the Subjects at the End of Period III
Time frame: At the end of Period III (Day 2)
Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
Time frame: At the end of Period III (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 4 study testing Montelukast and Levocetirizine in people with Rhinitis, Allergic, Seasonal, run by UCB S.A. - Pharma Sector 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 2 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 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 23 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; AzTrials last refreshed its copy on 8 Nov 2026.