Trial Outcomes & Findings for A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis (NCT NCT00621959)

Results Overview

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

596 participants

Primary outcome timeframe

Over the total treatment period (14 days)

Results posted on

2020-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Matched placebo tablets once daily	LCTZ 5 mg levocetirizine dihydrochloride tablet once daily
Overall Study STARTED	295	301
Overall Study COMPLETED	288	292
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matched placebo tablets once daily	LCTZ 5 mg levocetirizine dihydrochloride tablet once daily
Overall Study Adverse Event	4	2
Overall Study Lack of Efficacy	1	1
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	1
Overall Study Other	1	3

Baseline Characteristics

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=295 Participants Matched placebo tablets once daily	LCTZ n=301 Participants 5 mg levocetirizine dihydrochloride tablet once daily	Total n=596 Participants Total of all reporting groups
Age, Continuous	37.36 years STANDARD_DEVIATION 11.05 • n=5 Participants	37.02 years STANDARD_DEVIATION 11.99 • n=7 Participants	37.18 years STANDARD_DEVIATION 11.52 • n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	206 Participants n=7 Participants	405 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	95 Participants n=7 Participants	191 Participants n=5 Participants
Region of Enrollment United States	295 participants n=5 Participants	301 participants n=7 Participants	596 participants n=5 Participants

PRIMARY outcome

Timeframe: Over the total treatment period (14 days)

Population: Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.

Outcome measures

Outcome measures
Measure	Placebo n=294 Participants Matched placebo tablets once daily	LCTZ n=299 Participants 5 mg levocetirizine dihydrochloride tablet once daily
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)	8.96 points on a scale Standard Deviation 2.96	8.77 points on a scale Standard Deviation 3.28

SECONDARY outcome

Timeframe: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)

Population: Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.

Outcome measures

Outcome measures
Measure	Placebo n=294 Participants Matched placebo tablets once daily	LCTZ n=299 Participants 5 mg levocetirizine dihydrochloride tablet once daily
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score	-1.07 points on a scale Standard Deviation 1.26	-1.12 points on a scale Standard Deviation 1.25

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

LCTZ

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=295 participants at risk Matched placebo tablets once daily	LCTZ n=301 participants at risk 5 mg levocetirizine dihydrochloride tablet once daily
Gastrointestinal disorders Gastrooesophageal reflux disease	0.34% 1/295	0.00% 0/301
General disorders Non-cardiac chest pain	0.34% 1/295	0.00% 0/301
Psychiatric disorders Suicide attempt	0.34% 1/295	0.00% 0/301

Other adverse events

Other adverse events
Measure	Placebo n=295 participants at risk Matched placebo tablets once daily	LCTZ n=301 participants at risk 5 mg levocetirizine dihydrochloride tablet once daily
General disorders Fatigue	1.7% 5/295	3.0% 9/301
Nervous system disorders Headache	6.8% 20/295	3.3% 10/301
Nervous system disorders Somnolence	2.7% 8/295	4.0% 12/301

Additional Information

UCB Clinical Trial Call Center

UCB Pharma

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER