Seasonal Allergic RhinoconjunctivitisPhase 4SKYNCT02761252
Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma
A Phase 4 study testing Bilastine 20mg and Montelukast 10mg in people with Seasonal Allergic Rhinoconjunctivitis and Asthma, run by Menarini International Operations Luxembourg SA at 32 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinoconjunctivitis, Asthma
- What is being tested?
- Bilastine 20mg and Montelukast 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 13 Apr 2016to 24 Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
- 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.
Who cannot join
- 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;
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- 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;
- Pregnant or breast-feeding women;
- 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);
- Patients who had a recent history (within previous 12 months) of drug addiction or alcohol abuse based on Principal investigator's judgment ;
- Patients participating in or having participated in another clinical trial within the previous three months;
- Patients unable to take relief medications due to contraindications or intolerance;
- 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)
- Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
- Patients who are planning to travel outside the study area during the course of the study.
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
Poland12 sites
Study site
Bialystok
Study site
Bielsko-Biala
Study site
Gdansk
Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Nowy Duninów
Study site
Poznan
Study site
Rzeszów
Study site
Tarnów
Study site
Wroclaw
Italy5 sites
Study site
Catania
Study site
Florence
Study site
Modena
Study site
Pavia
Study site
Verona
Romania4 sites
Study site
Brasov
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Ploieşti
About this study
Official title: Bilastine and Montelukast in Patients With Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration - the SKY Study
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
Read the 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
- Being tested
- Bilastine 20mg, Montelukast 10mg, Placebo Bilastine 20mg, Placebo Montelukast 10mg
- Keywords
- Bilastine, Montelukast, total symptom score, AQLQ
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilastine 20mgDrug
Also called Robilas
Montelukast 10mgDrug
Also called Montelukast
Placebo Bilastine 20mgDrug
Also called Placebo Bilastine
Placebo Montelukast 10mgDrug
Also called Placebo Montelukast
| Study group | Role | What they receive |
|---|---|---|
| Bilastine+montelukast | Experimental | Bilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment Receives: 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. Receives: 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. Receives: Drug: Montelukast 10mg; Drug: Placebo Bilastine 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: After 4 weeks of treatments
Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)
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.
Measured: After 4 weeks of treatment (from baseline)
Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)
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.
Measured: After 4 weeks of treatment (from baseline)
Usage of Relief Medication for SARC
Number of days without any relief medication for SARC
Measured: From baseline to 4 weeks of treatment
Usage of Relief Medication for Asthma
Number of days without any relief medication for Asthma.
Measured: From baseline to 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start13 Apr 2016
- Primary completion24 Nov 2016
- Study completion24 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini International Operations Luxembourg SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Pistolesi, Prof, Study director, AOUC Azienda Ospedaliero-Universitaria CareggiOliviero Rossi, Prof, Study director, AOUC Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761252
- Sponsor's protocol ID
- MEIN/15/Bil-ARC/001
- Other IDs
- 2015-004806-40, 2015
- Acronym
- SKY
- Status last verified
- Apr 2019
- First submitted
- 28 Apr 2016
- Last updated
- 12 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilastine and Montelukast in Patients With Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration - the SKY Study
- ClinicalTrials.gov ID
- NCT02761252
- Acronym / sponsor ID
- SKY / MEIN/15/Bil-ARC/001
- Conditions
- Seasonal Allergic Rhinoconjunctivitis, Asthma
- Keywords
- Bilastine, Montelukast, total symptom score, AQLQ
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Menarini International Operations Luxembourg SAIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 24 Nov 2016 (actual)
- Study completion
- 24 Nov 2016 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Posted 12 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bilastine+montelukast | Experimental | Drug: Bilastine 20mg, Drug: Montelukast 10mgBilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment |
| Bilastine+placebo montelukast | Active comparator | Drug: Bilastine 20mg, Drug: Placebo Montelukast 10mgBilastine 20 mg, 10 blister containing 10 tablets + Placebo Montelukast, 10 blister containing 10 film coated tablets each. |
| Montelukast+placebo bilastine | Active comparator | Drug: Montelukast 10mg, Drug: Placebo Bilastine 20mgPlacebo Bilastine, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (32 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilastine 20mgAlso: Robilas | Drug | Bilastine+montelukast, Bilastine+placebo montelukast |
| Montelukast 10mgAlso: Montelukast | Drug | Bilastine+montelukast, Montelukast+placebo bilastine |
| Placebo Bilastine 20mgAlso: Placebo Bilastine | Drug | Montelukast+placebo bilastine |
| Placebo Montelukast 10mgAlso: Placebo Montelukast | Drug | Bilastine+placebo montelukast |
Primary outcome
Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms
Time frame: 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.
5 secondary outcomes
Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma Control
Time frame: After 4 weeks of treatments
Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)
Time frame: After 4 weeks of treatment (from baseline)
Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)
Time frame: After 4 weeks of treatment (from baseline)
Usage of Relief Medication for SARC
Time frame: From baseline to 4 weeks of treatment
Usage of Relief Medication for Asthma
Time frame: From baseline to 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Pistolesi, Prof study director
AOUC Azienda Ospedaliero-Universitaria Careggi
Oliviero Rossi, Prof study director
AOUC Azienda Ospedaliero-Universitaria Careggi
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bilastine 20mg and Montelukast 10mg in people with Seasonal Allergic Rhinoconjunctivitis and Asthma, run by Menarini International Operations Luxembourg SA at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Poland, Italy, Romania, Croatia, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms (time frame: 4 weeks of treatment (from baseline to 4 weeks of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.