Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

NCT02761252 | Completed Phase 4 Results

• 2 other identifiers: MEIN/15/Bil-ARC/0012015-004806-40
• Study Type: interventional
• Target: 454
• Locations: 8 countries
• Sites: 32

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

Conditions

Seasonal Allergic Rhinoconjunctivitis; Asthma

Keywords

Bilastine; Montelukast; total symptom score; AQLQ

Outcome Measures

Primary Outcomes (1)

• Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms

  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.

  4 weeks of treatment (from baseline to 4 weeks of treatment)

Secondary Outcomes (5)

• Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma Control

  After 4 weeks of treatments

• Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)

  After 4 weeks of treatment (from baseline)

• Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)

  After 4 weeks of treatment (from baseline)

• Usage of Relief Medication for SARC

  From baseline to 4 weeks of treatment

• Usage of Relief Medication for Asthma

  From baseline to 4 weeks of treatment

Study Arms (3)

Bilastine+montelukast

EXPERIMENTAL

Bilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment

Drug: Bilastine 20mg; Drug: Montelukast 10mg

Bilastine+placebo montelukast

ACTIVE COMPARATOR

Bilastine 20 mg, 10 blister containing 10 tablets + Placebo Montelukast, 10 blister containing 10 film coated tablets each.

Drug: Bilastine 20mg; Drug: Placebo Montelukast 10mg

Montelukast+placebo bilastine

ACTIVE COMPARATOR

Placebo Bilastine, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each.

Drug: Montelukast 10mg; Drug: Placebo Bilastine 20mg

Interventions

Bilastine 20mg DRUG

Also known as: Robilas

Bilastine+montelukast; Bilastine+placebo montelukast

Montelukast 10mg DRUG

Also known as: Montelukast

Bilastine+montelukast; Montelukast+placebo bilastine

Placebo Bilastine 20mg DRUG

Also known as: Placebo Bilastine

Montelukast+placebo bilastine

Placebo Montelukast 10mg DRUG

Also known as: Placebo Montelukast

Bilastine+placebo montelukast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older;
• Patients with at least 2 years history of SARC prior to the study and mild to moderate asthma (GINA criteria 2 and 3) inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provide inadequate clinical control;
• Forced expiratory volume at one second (FEV1) \> 70% of the predicted normal value demonstrable at least 6 hours after last short acting β-2 agonist use or 12 hours after last long acting β-2 agonist (LABA) use;
• Nasal Symptoms Score (NSS) at baseline ≥ 3. Baseline NSS will be defined as the mean of the 6 last assessments of the patients' diary (3 last days before randomization);
• Positive results of skin prick test on at least one seasonal allergen within the last 3 years;
• Patients who provided a signed written informed consent form;
• Patients who are able and willing to complete web-based Patient's Diary;
• Patients who agree to maintain consistency in their surroundings throughout the study period;
• Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year have to have a negative pregnancy test. Results have to be available until the Visit 2 and negative for the patient to be entered in the study.
• WOCBP have to use an effective method of birth control throughout the study period and for 4 weeks after study completion (defined as a method which results in a failure rate of less than 1% per year) such as:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion

You may not qualify if:

• Patients with hypersensitivity to any component of the study medications;
• Patients with non-allergic rhinoconjunctivitis (e.g. vasomotor, infectious, drug-induced);
• Presence of nasal polyps or any clinically important nasal anomaly;
• History of acute and/or chronic sinusitis within 30 days of Visit 2;
• History of eye surgery within 3 months of Visit 2;
• History of intranasal surgery within 3 months of Visit 2;
• Immunotherapy within 6 months prior to Visit 1;
• Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 2;
• Patients with moderate to severe renal impairment and taking P-gp inhibitors (e.g. ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem) within 7 days prior to the first dose of study medication;
• Patients requiring daily "controller" medications with cromolyn-type drugs or leukotriene antagonists;
• Patient required daily "controller" medication with Inhaled corticosteroids (ICS) or LABA at medium /high dosage defined by GINA criteria;
• Patients with clinically important (based on principal investigator's judgment) hepatic impairment;
• Patients with severe concomitant disease (based on principal investigator's judgment) that could interfere with treatment response;
• Patients with QT syndrome;
• Patients with Galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption;

Sponsors & Collaborators

• Menarini International Operations Luxembourg SA: lead

Study Sites (32)

Unknown Facility

Čakovec, Croatia

Location

Unknown Facility

Rijeka, Croatia

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Ostrava Hrabuvka, Czechia

Location

Unknown Facility

Teplice, Czechia

Location

Unknown Facility

Dreieich, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Catania, Italy

Location

Unknown Facility

Florence, Italy

Location

Unknown Facility

Modena, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Verona, Italy

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Bielsko-Biala, Poland

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Nowy Duninów, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Rzeszów, Poland

Location

Unknown Facility

Tarnów, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Brasov, Romania

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Cluj-Napoca, Romania

Location

Unknown Facility

Ploieşti, Romania

Location

Unknown Facility

Bardejov, Slovakia

Location

Unknown Facility

Levice, Slovakia

Location

MeSH Terms

Conditions

Asthma

Interventions

bilastine; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Menarini International Operations Luxembourg SA

aconte@menarini.lu

+352 2649761

Study Officials

• Massimo Pistolesi, Prof

  AOUC Azienda Ospedaliero-Universitaria Careggi

  STUDY DIRECTOR

• Oliviero Rossi, Prof

  AOUC Azienda Ospedaliero-Universitaria Careggi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator and study staff, subjects and monitors remained blinded to the treatment until study closure in this double-blind, double-dummy study. The identity of the study drug was revealed only if the subject experienced a medical emergency the management of which would be improved by the knowledge of the blinded treatment assignment. As the combination therapy of Bilastine + Montelukast consisted of two tablets in contrast to monotherapy with either Bilastine or Montelukast, the double-dummy technique was applied with matching placebo for each Investigation Medicinal Product (IMP) (monotherapy with Bilastine or Montelukast) to ensure the maintenance of double-blind conditions. Therefore, each patient took 2 tablets with each dose administered. As by randomisation list, each Patient Kit consisted of two IMP treatments (either active + placebo or active + active) in separate blisters packed in two different boxes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was a randomised (1:1:1), double-blind, double-dummy, interventional, active-controlled, parallel groups (three groups), multi-centre, multi-national, superiority clinical trial. The study plan included a 7-day (± 4) run-in period to ensure wash-out from previous forbidden treatments and to perform the tests required to ensure appropriate patient enrolment into the study. The active treatment period was 12 weeks (85 days) with a follow-up visit (phone call) at 28 days (± 4) after the End of Treatment.

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 4, 2016
• Study Start: April 13, 2016
• Primary Completion: November 24, 2016
• Study Completion: November 24, 2016
• Last Updated: July 12, 2019
• Results First Posted: July 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); DE (2); CZ (3); CR (3); IT (5); LA (1); PL (12); RO (4)