Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma
- Conditions
- Seasonal Allergic RhinoconjunctivitisAsthma
- Interventions
- Registration Number
- NCT02761252
- Lead Sponsor
- Menarini International Operations Luxembourg SA
- Brief Summary
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
- Detailed Description
The present study (SKY) was designed to show if once daily oral combination therapy with Montelukast 10 mg and Bilastine 20 mg is superior to monotherapy with Bilastine 20 mg in patients with Seasonal Allergic RhinoConjunctivitis (SARC) and comorbid mild to moderate asthma on total symptom scores (TSS) and if the combination therapy reflects an improvement in quality of life as assessed via the Asthma Quality of Life Questionnaire (AQLQ) over a longer time period when compared to monotherapies with Montelukast 10 mg and Bilastine 20 mg. Mild to moderate asthma was defined according to the criteria of the Global Initiative for Asthma, i.e., GINA criteria 2 and 3 (GINA, 2012). The study population included patients inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provided inadequate clinical control.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 454
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bilastine+montelukast Bilastine 20mg Bilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment Bilastine+montelukast Montelukast 10mg Bilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment Bilastine+placebo montelukast Placebo Montelukast 10mg Bilastine 20 mg, 10 blister containing 10 tablets + Placebo Montelukast, 10 blister containing 10 film coated tablets each. Bilastine+placebo montelukast Bilastine 20mg Bilastine 20 mg, 10 blister containing 10 tablets + Placebo Montelukast, 10 blister containing 10 film coated tablets each. Montelukast+placebo bilastine Montelukast 10mg Placebo Bilastine, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each. Montelukast+placebo bilastine Placebo Bilastine 20mg Placebo Bilastine, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each.
- Primary Outcome Measures
Name Time Method Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms 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 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep
* 3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.
TSS assessment comprises of scoring (0-3) of all 7 above mentioned symptoms. Final TSS scores is in a range from 0-21.
- Secondary Outcome Measures
Name Time Method Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS) 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 is bothersome but tolerable, does not interfere with daily activities or sleep
* 3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.
DNSS assessment comprises of scoring (0-3) of all 4 above mentioned symptoms. Final DNSS scores is in a range from 0-12.Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS) 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 is bothersome but tolerable, does not interfere with daily activities or sleep
* 3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.
DNNSS assessment comprises of scoring (0-3) of all 3 above mentioned symptoms. Final DNNSS scores is in a range from 0-9.Usage of Relief Medication for SARC From baseline to 4 weeks of treatment Number of days without any relief medication for SARC
Usage of Relief Medication for Asthma From baseline to 4 weeks of treatment Number of days without any relief medication for Asthma.
Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma Control 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.co.uk/aqlq.html).
The change in AQLQ score from baseline to 4 weeks after treatment - AQLQ score at baseline for patients with both available values has been the secondary endpoint.