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

NCT ID: NCT02761252

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-13
• Study Completion Date: 2016-11-24

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.

Conditions

Seasonal Allergic Rhinoconjunctivitis; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bilastine+montelukast

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

Group Type: EXPERIMENTAL

Bilastine 20mg

Intervention Type: DRUG

Montelukast 10mg

Intervention Type: DRUG

Bilastine+placebo montelukast

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

Group Type: ACTIVE_COMPARATOR

Bilastine 20mg

Intervention Type: DRUG

Placebo Montelukast 10mg

Intervention Type: DRUG

Montelukast+placebo bilastine

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

Group Type: ACTIVE_COMPARATOR

Montelukast 10mg

Intervention Type: DRUG

Placebo Bilastine 20mg

Intervention Type: DRUG

Interventions

Bilastine 20mg

Intervention Type: DRUG

Montelukast 10mg

Intervention Type: DRUG

Placebo Bilastine 20mg

Intervention Type: DRUG

Placebo Montelukast 10mg

Intervention Type: DRUG

Other Intervention Names

Robilas; Montelukast; Placebo Bilastine; Placebo Montelukast

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 years or older;

2. 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;

3. 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;

4. 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);

5. Positive results of skin prick test on at least one seasonal allergen within the last 3 years;

6. Patients who provided a signed written informed consent form;

7. Patients who are able and willing to complete web-based Patient's Diary;

8. Patients who agree to maintain consistency in their surroundings throughout the study period;

9. 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.

10. 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
• vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)
• sexual abstinence In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycles.

Exclusion Criteria

1. Patients with hypersensitivity to any component of the study medications;

2. Patients with non-allergic rhinoconjunctivitis (e.g. vasomotor, infectious, drug-induced);

3. Presence of nasal polyps or any clinically important nasal anomaly;

4. History of acute and/or chronic sinusitis within 30 days of Visit 2;

5. History of eye surgery within 3 months of Visit 2;

6. History of intranasal surgery within 3 months of Visit 2;

7. Immunotherapy within 6 months prior to Visit 1;

8. Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 2;

9. 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;

10. Patients requiring daily "controller" medications with cromolyn-type drugs or leukotriene antagonists;

11. Patient required daily "controller" medication with Inhaled corticosteroids (ICS) or LABA at medium /high dosage defined by GINA criteria;

12. Patients with clinically important (based on principal investigator's judgment) hepatic impairment;

13. Patients with severe concomitant disease (based on principal investigator's judgment) that could interfere with treatment response;

14. Patients with QT syndrome;

15. Patients with Galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption;

16. Pregnant or breast-feeding women;

17. Patients with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study (based on principal investigator's judgment);

18. Patients who had a recent history (within previous 12 months) of drug addiction or alcohol abuse based on Principal investigator's judgment ;

19. Patients participating in or having participated in another clinical trial within the previous three months;

20. Patients unable to take relief medications due to contraindications or intolerance;

21. Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period:

• Antihistaminic drugs or montelukast (7 days)
• Systemic or intranasal corticosteroids (4 weeks)
• Delayed-release corticosteroids (3 months)
• Ketotifen (2 weeks)
• Macrolides antibiotics and imidazolic antifungals (systemic)(7 days)
• Anticholinergics (7 days)
• Drugs with antihistamine properties (phenothiazine) (7 days)
• Intranasal and systemic decongestants (3 days)
• Lodoxamide (7 days)

22. Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.

23. Patients who are planning to travel outside the study area during the course of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini International Operations Luxembourg SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Pistolesi, Prof

Role: STUDY_DIRECTOR

AOUC Azienda Ospedaliero-Universitaria Careggi

Oliviero Rossi, Prof

Role: STUDY_DIRECTOR

AOUC Azienda Ospedaliero-Universitaria Careggi

Locations

Čakovec, , Croatia

Rijeka, , Croatia

Zagreb, , Croatia

Brno, , Czechia

Ostrava Hrabuvka, , Czechia

Teplice, , Czechia

Dreieich, , Germany

Heidelberg, , Germany

Catania, , Italy

Florence, , Italy

Modena, , Italy

Pavia, , Italy

Verona, , Italy

Riga, , Latvia

Bialystok, , Poland

Bielsko-Biala, , Poland

Gdansk, , Poland

Katowice, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Nowy Duninów, , Poland

Poznan, , Poland

Rzeszów, , Poland

Tarnów, , Poland

Wroclaw, , Poland

Brasov, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Ploieşti, , Romania

Bardejov, , Slovakia

Levice, , Slovakia

Countries

Croatia; Czechia; Germany; Italy; Latvia; Poland; Romania; Slovakia

Other Identifiers

2015-004806-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MEIN/15/Bil-ARC/001

Identifier Type: -

Identifier Source: org_study_id