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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291642
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : July 20, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief 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 Unit.

Condition or disease Intervention/treatment Phase
Rhinitis Allergic Seasonal Drug: Placebo drops Drug: Placebo tablets matching to levocetirizine Drug: Placebo tablets matching to cetirizine Drug: Levocetirizine drops Drug: Levocetirizine tablets Drug: Cetirizine drops Drug: Cetirizine tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 551 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : January 1, 2006
Actual Primary Completion Date : April 1, 2006
Actual Study Completion Date : April 1, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Placebo Comparator: Placebo (PBO)
A single dose of placebo was administered orally on Day 1.
Drug: Placebo drops
  • Pharmaceutical form: Drops for oral administration
  • Route of administration: Oral use

Drug: Placebo tablets matching to levocetirizine
  • Pharmaceutical form: Tablets for oral administration
  • Route of administration: Oral use

Drug: Placebo tablets matching to cetirizine
  • Pharmaceutical form: Tablets for oral administration
  • Route of administration: Oral use

Experimental: Levocetirizine (LCTZ) 2.5 mg
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
Drug: Levocetirizine drops
  • Pharmaceutical form: Drops for oral administration
  • Concentration: 5 mg/ml
  • Route of administration: Oral use
Other Name: Xyzal

Experimental: Levocetirizine (LCTZ) 5 mg
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
Drug: Levocetirizine tablets
  • Pharmaceutical form: Tablets for oral administration
  • Concentration: 5 mg
  • Route of administration: Oral use
Other Name: Xyzal

Experimental: Cetirizine (CTZ) 5 mg
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
Drug: Cetirizine drops
  • Pharmaceutical form: Drops for oral administration
  • Concentration: 10 mg/ml
  • Route of administration: Oral use

Experimental: Cetirizine (CTZ) 10 mg
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Drug: Cetirizine tablets
  • Pharmaceutical form: Tablets for oral administration
  • Concentration: 10 mg
  • Route of administration: Oral use




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)] ]

    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.


  2. Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) [ Time Frame: Baseline to Day 2 ]

    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.


  3. 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)] ]

    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.


  4. 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)] ]

    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.


  5. 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 ]

    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.


  6. 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)] ]

    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.


  7. 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)] ]

    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.


  8. Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) [ Time Frame: Baseline to Day 2 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291642


Locations
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Canada, Ontario
Kingston, Ontario, Canada
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Cares UCB (+1 844 599 2273)
Additional Information:
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00291642    
Other Study ID Numbers: A00412
First Posted: February 14, 2006    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: September 11, 2018
Last Verified: August 1, 2018
Keywords provided by UCB Pharma:
Levocetirizine
Xyzal
Rhinitis
Allergic
Seasonal
Ragweed
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Levocetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs