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Completed

NCT Number: NCT00291642

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 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.

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Key information

Conditions

Rhinitis Allergic Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Seasonal

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo drops

Drug
  • Pharmaceutical form: Drops for oral administration
  • Route of administration: Oral use

Placebo tablets matching to levocetirizine

Drug
  • Pharmaceutical form: Tablets for oral administration
  • Route of administration: Oral use

Placebo tablets matching to cetirizine

Drug
  • Pharmaceutical form: Tablets for oral administration
  • Route of administration: Oral use

Levocetirizine drops

Drug
  • Pharmaceutical form: Drops for oral administration
  • Concentration: 5 mg/ml
  • Route of administration: Oral use

Other names: Xyzal

Levocetirizine tablets

Drug
  • Pharmaceutical form: Tablets for oral administration
  • Concentration: 5 mg
  • Route of administration: Oral use

Other names: Xyzal

Cetirizine drops

Drug
  • Pharmaceutical form: Drops for oral administration
  • Concentration: 10 mg/ml
  • Route of administration: Oral use

Cetirizine tablets

Drug
  • Pharmaceutical form: Tablets for oral administration
  • Concentration: 10 mg
  • Route of administration: Oral use

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 14, 2006
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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