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

Completed Phase 2 Results posted Last updated 11 September 2018

What this trial tests

Phase 2 trial testing Placebo drops in Rhinitis in 551 participants. Completed in 1 April 2006.

Timeline

1 January 2006

Primary endpoint
1 April 2006

1 April 2006

Quick facts

Lead sponsor	UCB Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	551
Start date	1 January 2006
Primary completion	1 April 2006
Estimated completion	1 April 2006
Sites	1 location across Canada

Drugs / interventions tested

• Placebo drops
• Placebo tablets matching to levocetirizine — full drug profile →
• Placebo tablets matching to cetirizine — full drug profile →
• Levocetirizine drops
• Levocetirizine tablets — full drug profile →
• Cetirizine drops — full drug profile →
• Cetirizine tablets — full drug profile →

Conditions studied

• Rhinitis — all drugs for Rhinitis →
• Allergic — all drugs for Allergic →
• Seasonal — all drugs for Seasonal →

Sponsor

UCB Pharma — full company profile →

Who can join

16 and older, any sex, with Rhinitis or Allergic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I Primary · 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 range

Group	Value	95% CI
Placebo (PBO)	-3.80	± 0.495
Levocetirizine (LCTZ) 2.5 mg	-7.15	± 0.406
Levocetirizine (LCTZ) 5 mg	-7.05	± 0.401
Cetirizine (CTZ) 5 mg	-7.93	± 0.401
Cetirizine (CTZ) 10 mg	-7.54	± 0.401

Change From Baseline in the MSC Score Over Period II Secondary · 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 range

Group	Value	95% CI
Placebo (PBO)	-3.50	± 0.604
Levocetirizine (LCTZ) 2.5 mg	-6.35	± 0.489
Levocetirizine (LCTZ) 5 mg	-7.07	± 0.487
Cetirizine (CTZ) 5 mg	-6.78	± 0.483
Cetirizine (CTZ) 10 mg	-7.92	± 0.485

Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) Secondary · 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 range

Group	Value	95% CI
Placebo (PBO)	-3.61	± 0.473
Levocetirizine (LCTZ) 2.5 mg	-6.80	± 0.388
Levocetirizine (LCTZ) 5 mg	-7.10	± 0.383
Cetirizine (CTZ) 5 mg	-7.43	± 0.384
Cetirizine (CTZ) 10 mg	-7.72	± 0.383

Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I Secondary · 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 TS

Group	Value	95% CI
Placebo (PBO)	-6.55	± 0.757
Levocetirizine (LCTZ) 2.5 mg	-11.33	± 0.620
Levocetirizine (LCTZ) 5 mg	-11.27	± 0.613
Cetirizine (CTZ) 5 mg	-12.71	± 0.613
Cetirizine (CTZ) 10 mg	-11.74	± 0.613

Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II Secondary · 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 TS

Group	Value	95% CI
Placebo (PBO)	-5.73	± 0.917
Levocetirizine (LCTZ) 2.5 mg	-10.25	± 0.742
Levocetirizine (LCTZ) 5 mg	-11.03	± 0.739
Cetirizine (CTZ) 5 mg	-10.73	± 0.734
Cetirizine (CTZ) 10 mg	-12.14	± 0.736

Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) Secondary · 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 TS

Group	Value	95% CI
Placebo (PBO)	-6.10	± 0.729
Levocetirizine (LCTZ) 2.5 mg	-10.86	± 0.598
Levocetirizine (LCTZ) 5 mg	-11.22	± 0.591
Cetirizine (CTZ) 5 mg	-11.84	± 0.591
Cetirizine (CTZ) 10 mg	-11.92	± 0.591

Change From Baseline in the Individual Symptom Scores Over Period I Secondary · 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.

Runny Nose Score

Group	Value	95% CI
Placebo (PBO)	-0.60	± 0.095
Levocetirizine (LCTZ) 2.5 mg	-1.01	± 0.078
Levocetirizine (LCTZ) 5 mg	-0.95	± 0.077
Cetirizine (CTZ) 5 mg	-1.17	± 0.077
Cetirizine (CTZ) 10 mg	-1.04	± 0.077

Itchy Nose Score

Group	Value	95% CI
Placebo (PBO)	-0.66	± 0.099
Levocetirizine (LCTZ) 2.5 mg	-1.03	± 0.082
Levocetirizine (LCTZ) 5 mg	-1.09	± 0.081
Cetirizine (CTZ) 5 mg	-1.28	± 0.081
Cetirizine (CTZ) 10 mg	-1.10	± 0.081

Sniffles Score

Group	Value	95% CI
Placebo (PBO)	-0.65	± 0.100
Levocetirizine (LCTZ) 2.5 mg	-1.15	± 0.082
Levocetirizine (LCTZ) 5 mg	-1.06	± 0.081
Cetirizine (CTZ) 5 mg	-1.24	± 0.081
Cetirizine (CTZ) 10 mg	-1.10	± 0.081

Nose Blow Score

Group	Value	95% CI
Placebo (PBO)	-0.98	± 0.129
Levocetirizine (LCTZ) 2.5 mg	-1.87	± 0.106
Levocetirizine (LCTZ) 5 mg	-1.82	± 0.105
Cetirizine (CTZ) 5 mg	-1.92	± 0.105
Cetirizine (CTZ) 10 mg	-1.96	± 0.105

Sneezes Score

Group	Value	95% CI
Placebo (PBO)	-0.37	± 0.103
Levocetirizine (LCTZ) 2.5 mg	-1.15	± 0.084
Levocetirizine (LCTZ) 5 mg	-1.07	± 0.083
Cetirizine (CTZ) 5 mg	-1.22	± 0.083
Cetirizine (CTZ) 10 mg	-1.23	± 0.083

Watery Eyes Score

Group	Value	95% CI
Placebo (PBO)	-0.56	± 0.090
Levocetirizine (LCTZ) 2.5 mg	-0.94	± 0.074
Levocetirizine (LCTZ) 5 mg	-1.08	± 0.073
Cetirizine (CTZ) 5 mg	-1.13	± 0.073
Cetirizine (CTZ) 10 mg	-1.07	± 0.073

Change From Baseline in the Individual Symptom Scores Over Period II Secondary · 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.

Runny Nose Score

Group	Value	95% CI
Placebo (PBO)	-0.62	± 0.122
Levocetirizine (LCTZ) 2.5 mg	-0.86	± 0.098
Levocetirizine (LCTZ) 5 mg	-0.94	± 0.098
Cetirizine (CTZ) 5 mg	-0.95	± 0.097
Cetirizine (CTZ) 10 mg	-1.10	± 0.098

Itchy Nose Score

Group	Value	95% CI
Placebo (PBO)	-0.57	± 0.120
Levocetirizine (LCTZ) 2.5 mg	-1.00	± 0.097
Levocetirizine (LCTZ) 5 mg	-1.11	± 0.097
Cetirizine (CTZ) 5 mg	-1.13	± 0.096
Cetirizine (CTZ) 10 mg	-1.24	± 0.096

Sniffles Score

Group	Value	95% CI
Placebo (PBO)	-0.58	± 0.127
Levocetirizine (LCTZ) 2.5 mg	-0.91	± 0.103
Levocetirizine (LCTZ) 5 mg	-0.96	± 0.102
Cetirizine (CTZ) 5 mg	-0.90	± 0.101
Cetirizine (CTZ) 10 mg	-1.21	± 0.102

Nose Blow Score

Group	Value	95% CI
Placebo (PBO)	-1.00	± 0.162
Levocetirizine (LCTZ) 2.5 mg	-1.61	± 0.131
Levocetirizine (LCTZ) 5 mg	-1.84	± 0.131
Cetirizine (CTZ) 5 mg	-1.78	± 0.130
Cetirizine (CTZ) 10 mg	-2.02	± 0.130

Sneezes Score

Group	Value	95% CI
Placebo (PBO)	-0.48	± 0.112
Levocetirizine (LCTZ) 2.5 mg	-1.18	± 0.091
Levocetirizine (LCTZ) 5 mg	-1.33	± 0.090
Cetirizine (CTZ) 5 mg	-1.19	± 0.089
Cetirizine (CTZ) 10 mg	-1.38	± 0.090

Watery Eyes Score

Group	Value	95% CI
Placebo (PBO)	-0.30	± 0.119
Levocetirizine (LCTZ) 2.5 mg	-0.78	± 0.097
Levocetirizine (LCTZ) 5 mg	-0.91	± 0.096
Cetirizine (CTZ) 5 mg	-0.83	± 0.096
Cetirizine (CTZ) 10 mg	-0.93	± 0.096

Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Secondary · 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.

Runny Nose Score

Group	Value	95% CI
Placebo (PBO)	-0.59	± 0.093
Levocetirizine (LCTZ) 2.5 mg	-0.94	± 0.076
Levocetirizine (LCTZ) 5 mg	-0.95	± 0.075
Cetirizine (CTZ) 5 mg	-1.07	± 0.075
Cetirizine (CTZ) 10 mg	-1.06	± 0.075

Itchy Nose Score

Group	Value	95% CI
Placebo (PBO)	-0.61	± 0.097
Levocetirizine (LCTZ) 2.5 mg	-1.02	± 0.080
Levocetirizine (LCTZ) 5 mg	-1.10	± 0.079
Cetirizine (CTZ) 5 mg	-1.21	± 0.079
Cetirizine (CTZ) 10 mg	-1.16	± 0.079

Sniffles Score

Group	Value	95% CI
Placebo (PBO)	-0.60	± 0.098
Levocetirizine (LCTZ) 2.5 mg	-1.05	± 0.080
Levocetirizine (LCTZ) 5 mg	-1.02	± 0.079
Cetirizine (CTZ) 5 mg	-1.09	± 0.079
Cetirizine (CTZ) 10 mg	-1.15	± 0.079

Nose Blow Score

Group	Value	95% CI
Placebo (PBO)	-0.98	± 0.124
Levocetirizine (LCTZ) 2.5 mg	-1.75	± 0.102
Levocetirizine (LCTZ) 5 mg	-1.83	± 0.100
Cetirizine (CTZ) 5 mg	-1.86	± 0.101
Cetirizine (CTZ) 10 mg	-1.99	± 0.100

Sneezes Score

Group	Value	95% CI
Placebo (PBO)	-0.41	± 0.090
Levocetirizine (LCTZ) 2.5 mg	-1.17	± 0.074
Levocetirizine (LCTZ) 5 mg	-1.19	± 0.073
Cetirizine (CTZ) 5 mg	-1.21	± 0.073
Cetirizine (CTZ) 10 mg	-1.31	± 0.073

Watery Eyes Score

Group	Value	95% CI
Placebo (PBO)	-0.44	± 0.089
Levocetirizine (LCTZ) 2.5 mg	-0.87	± 0.073
Levocetirizine (LCTZ) 5 mg	-1.01	± 0.072
Cetirizine (CTZ) 5 mg	-1.00	± 0.073
Cetirizine (CTZ) 10 mg	-1.01	± 0.072

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from Day 1 until up to 9 days after the study drug intake.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (PBO)

Serious: 0/78 (0%)

Deaths: 0/78

Levocetirizine (LCTZ) 2.5 mg

Serious: 0/116 (0%)

Deaths: 0/116

Levocetirizine (LCTZ) 5 mg

Serious: 0/119 (0%)

Deaths: 0/119

Cetirizine (CTZ) 5 mg

Serious: 0/119 (0%)

Deaths: 0/119

Cetirizine (CTZ) 10 mg

Serious: 0/119 (0%)

Deaths: 0/119

Other adverse events (34 terms — click to expand)

Reaction	System	Placebo (PBO)	Levocetirizine (LCTZ) 2.5 mg	Levocetirizine (LCTZ) 5 mg	Cetirizine (CTZ) 5 mg	Cetirizine (CTZ) 10 mg
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Conjunctivitis	Eye disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Defaecation urgency	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Syncope vasovagal	Nervous system disorders	—	—	—	—	—
Nervousness	Psychiatric disorders	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Nasal dryness	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Throat tightness	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Periorbital oedema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—
Swelling face	Skin and subcutaneous tissue disorders	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT00291642 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.