NCT00295022

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

Completed Phase 4 Results posted Last updated 11 September 2018

What this trial tests

Phase 4 trial testing Placebo in Rhinitis, Allergic, Seasonal in 418 participants. Completed in 1 October 2006.

Timeline

29 July 2006

Primary endpoint
1 October 2006

1 October 2006

Quick facts

Lead sponsor	UCB S.A. - Pharma Sector
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	418
Start date	29 July 2006
Primary completion	1 October 2006
Estimated completion	1 October 2006
Sites	1 location across Canada

Drugs / interventions tested

• Placebo
• Montelukast (montelukast) — full drug profile →
• Levocetirizine (LEVOCETIRIZINE) — full drug profile →

Conditions studied

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

Sponsor

UCB S.A. - Pharma Sector

Who can join

18 and older, any sex, with Rhinitis, Allergic, Seasonal. 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)	-3.46	± 0.49
Levocetirizine (LCTZ)	-6.58	± 0.40
Montelukast (MLKT)	-5.65	± 0.40

Change From Baseline in the MSC Score Over Period II Secondary · Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

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)	-1.22	± 0.52
Levocetirizine (LCTZ)	-6.35	± 0.42
Montelukast (MLKT)	-3.24	± 0.43

Change From Baseline in the MSC Score Over Period III Secondary · Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 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	± 0.58
Montelukast (MLKT)	-8.62	± 0.47
Levocetirizine (LCTZ)	-6.19	± 0.48

Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) 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)	-3.16	± 0.46
Levocetirizine (LCTZ)	-7.37	± 0.38
Montelukast (MLKT)	-5.48	± 0.38

Change From Baseline in the Total Symptom Complex (TSC) Score 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)]

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)	-6.16	± 0.75
Levocetirizine (LCTZ)	-10.53	± 0.61
Montelukast (MLKT)	-9.01	± 0.61

Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II Secondary · Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

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)	-2.45	± 0.76
Levocetirizine (LCTZ)	-9.54	± 0.62
Montelukast (MLKT)	-5.12	± 0.63

Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III Secondary · Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 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)	-5.91	± 0.88
Levocetirizine (LCTZ)	-13.39	± 0.72
Montelukast (MLKT)	-9.73	± 0.73

Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) 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)	-5.53	± 0.72
Levocetirizine (LCTZ)	-11.54	± 0.59
Montelukast (MLKT)	-8.68	± 0.59

Change From Baseline in the TSC Score + Nasal Congestion Score 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)]

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 N

Group	Value	95% CI
Placebo (PBO)	-6.57	± 0.80
Levocetirizine (LCTZ)	-11.15	± 0.66
Montelukast (MLKT)	-9.65	± 0.66

Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II Secondary · Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

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 N

Group	Value	95% CI
Placebo (PBO)	-2.65	± 0.80
Levocetirizine (LCTZ)	-9.97	± 0.65
Montelukast (MLKT)	-5.47	± 0.66

Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III Secondary · Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 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 N

Group	Value	95% CI
Placebo (PBO)	-6.35	± 0.94
Levocetirizine (LCTZ)	-14.18	± 0.77
Montelukast (MLKT)	-10.39	± 0.78

Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) 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 N

Group	Value	95% CI
Placebo (PBO)	-5.92	± 0.77
Levocetirizine (LCTZ)	-12.21	± 0.63
Montelukast (MLKT)	-9.28	± 0.63

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded in Study Phase II and in Study Phase III (Day 1 and Day 2), before and after each pollen exposure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (PBO)

Serious: 0/105 (0%)

Deaths: 0/105

Levocetirizine (LCTZ)

Serious: 0/157 (0%)

Deaths: 0/157

Montelukast (MLKT)

Serious: 0/156 (0%)

Deaths: 0/156

Other adverse events (31 terms — click to expand)

Reaction	System	Placebo (PBO)	Levocetirizine (LCTZ)	Montelukast (MLKT)
Headache	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—
Fatigue	General disorders	—	—	—
Somnolence	Nervous system disorders	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—
Conjunctivitis	Eye disorders	—	—	—
Eye pruritus	Eye disorders	—	—	—
Eye swelling	Eye disorders	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Feeling hot	General disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Conjunctivitis bacterial	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Blood pressure increased	Investigations	—	—	—
Body temperature increased	Investigations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—
Nodule on extremity	Musculoskeletal and connective tissue disorders	—	—	—
Sinus headache	Nervous system disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Skin lesion	Skin and subcutaneous tissue disorders	—	—	—
Urticaria localised	Skin and subcutaneous tissue disorders	—	—	—
Flushing	Vascular disorders	—	—	—

Data from ClinicalTrials.gov NCT00295022 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of non-sedating H1-receptor antihistamines in adults and adolescents with chronic cough: A systematic review.
   Lee JH, Lee JW, An J, Won HK, et al · · 2021 · cited 11× · PMID 34386152 · DOI 10.1016/j.waojou.2021.100568