18 and older, any sex, with Seasonal Allergic Rhinoconjunctivitis or Asthma. 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 With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC SymptomsPrimary· 4 weeks of treatment (from baseline to 4 weeks of treatment)
To demonstrate that concomitant administration of montelukast and bilastine is superior to bilastine monotherapy in SARC symptoms, as assessed by Total Symptoms Scores (TSS) after 4 weeks of treatment.
Total Symptoms Scores (TSS) assesses nasal (nasal congestion, rhinorrhea, nasal itching, sneezing) and non nasal symptoms (ocular redness, ocular itching, tearing) of rhinoconjuctivits.
Each of the 7 symptoms is scored from 0 (absent) to 3 (severe) as follows:
* 0 (absent) Symptom not present
* 1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness
* 2 (modera
Group
Value
95% CI
Bilastine+Montelukast
-3.2522
-3.8718 – -2.6327
Bilastine Monotherapy
-3.4462
-4.0708 – -2.8217
Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma ControlSecondary· After 4 weeks of treatments
To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in asthma control, as assessed by Asthma Quality of Life Questionnaire (AQLQ) after 4 weeks.
The AQLQ was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.
Each of the 32 questionnaire's items will be scored on a 7-point scale (where 7 means "not impaired at all" and 1 means "severely impaired"). The overall AQLQ score is the mean of all 32 responses (https://www.qoltech
Group
Value
95% CI
Bilastine+Montelukast
0.6250
0.4788 – 0.7712
Bilastine Monotherapy
0.6399
0.4929 – 0.7870
Montelukast Monotherapy
0.5849
0.4344 – 0.7353
Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)Secondary· After 4 weeks of treatment (from baseline)
To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Nasal Symptom Score (DNSS) after 4 weeks of treatment.
Daytime Nasal Symptom Score (DNSS) is the average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing of rhinoconjuctivits.
Each of the 4 symptoms is scored from 0 (absent) to 3 (severe) as follows:
* 0 (absent) Symptom not present
* 1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness
* 2 (moderate) Symptom
Group
Value
95% CI
Bilastine+Montelukast
-1.9713
-2.3442 – -1.5984
Bilastine Monotherapy
-2.1106
-2.4863 – -1.7349
Montelukast Monotherapy
-1.8678
-2.2468 – -1.4888
Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)Secondary· After 4 weeks of treatment (from baseline)
To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Non Nasal Symptom Score (DNNSS) after 4 weeks of treatment.
Daytime Non Nasal Symptom Score (DNSS) is the average of individual scores of ocular redness, ocular itching and tearing of rhinoconjuctivits.
Each of the 3 symptoms is scored from 0 (absent) to 3 (severe) as follows:
* 0 (absent) Symptom not present
* 1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness
* 2 (moderate) Symptom i
Group
Value
95% CI
Bilastine+Montelukast
-1.2824
-1.5667 – -0.9980
Bilastine Monotherapy
-1.3185
-1.6051 – -1.0320
Montelukast Monotherapy
-1.1574
-1.4462 – -0.8687
Usage of Relief Medication for SARCSecondary· From baseline to 4 weeks of treatment
Number of days without any relief medication for SARC
Group
Value
95% CI
Bilastine+Montelukast
15.0057
± 0.8260
Bilastine Monotherapy
15.8416
± 0.8326
Montelukast Monotherapy
15.4179
± 0.8411
Usage of Relief Medication for AsthmaSecondary· From baseline to 4 weeks of treatment
Number of days without any relief medication for Asthma.
Group
Value
95% CI
Bilastine+Montelukast
53.2548
± 2.0193
Bilastine Monotherapy
52.4177
± 2.0212
Montelukast Monotherapy
50.7146
± 2.0768
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Menarini International Operations Luxembourg SA
Last refreshed: 12 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02761252.