Acute BronchiolitisPhase 4NCT04613180
Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
A Phase 4 study testing Montelukast Sodium in people with Acute Bronchiolitis, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
Trial summary
The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Acute Bronchiolitis
- What is being tested?
- Montelukast Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUzbekistan
- Study dates
- 3 Jan 2018to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- RDA score=6 points
- E:I index score >1.40
- ineffective treatment at home for ≥48 hours
- adverse comorbidities
Who cannot join
- chronic or congenital diseases of the Central nervous, cardiovascular and bronchopulmonary systems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups.
Read the detailed description
The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups. Group I (control) included 40 patients who received standard therapy and placebo. Group II (main) included 40 patients who received standart therapy and oral montelukast sodium.
- Conditions
- Acute Bronchiolitis
- Being tested
- Montelukast Sodium, Placebo
- Keywords
- Montelukast sodium, Prevention, Relapse, Obstructive bronchitis
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast SodiumDrug
Also called Singulair
Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older.
PlaceboDrug
placebo containing no active substance
| Study group | Role | What they receive |
|---|---|---|
| Group I (control group) | Placebo comparator | 40 patients with obstructive bronchitis who received placebo Receives: Drug: Placebo |
| Group II | Active comparator | 40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day Receives: Drug: Montelukast Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis
Children aged 1 to 7 years with recurrent obstructive bronchitis who will be treated in the Emergency Pediatrics and pediatric intensive care departments of the Emergency hospital of Samarkand will be examined. Patients will be randomly divided into 2 groups. Group I (control) will include 40 patients who received standard therapy and placebo. Group II will include 40 patients who received oral montelukast sodium in addition to standard therapy. Modified bronchophonography will be used to determine the effectiveness of the therapy.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start3 Jan 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchiolitisStudies 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
- Patients were randomly divided into 2 groups. I the group (control) included 40 patients who received standard therapy. The second group included 40 patients who received oral montelukast sodium. The therapeutic dosage of the drug was 0.2 mg/kg/day, the daily dose was prescribed once a day for the entire duration of the disease. As a prevention of repeated episodes of bronchial obstructive syndrome, the drug was prescribed at a dose of 0.1 mg/kg/day, the duration of anti-relapse therapy was 30 days.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samarkand State Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613180
- Sponsor's protocol ID
- DGU 20170692
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
- ClinicalTrials.gov ID
- NCT04613180
- Acronym / sponsor ID
- DGU 20170692
- Conditions
- Acute Bronchiolitis
- Keywords
- Montelukast sodium, Prevention, Relapse, Obstructive bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samarkand State Medical InstituteUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups.
Detailed description
The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups. Group I (control) included 40 patients who received standard therapy and placebo. Group II (main) included 40 patients who received standart therapy and oral montelukast sodium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly divided into 2 groups. I the group (control) included 40 patients who received standard therapy. The second group included 40 patients who received oral montelukast sodium. The therapeutic dosage of the drug was 0.2 mg/kg/day, the daily dose was prescribed once a day for the entire duration of the disease. As a prevention of repeated episodes of bronchial obstructive syndrome, the drug was prescribed at a dose of 0.1 mg/kg/day, the duration of anti-relapse therapy was 30 days.
| Arm | Type | Receives |
|---|---|---|
| Group I (control group) | Placebo comparator | Drug: Placebo40 patients with obstructive bronchitis who received placebo |
| Group II | Active comparator | Drug: Montelukast Sodium40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- RDA score=6 points
- E:I index score >1.40
- ineffective treatment at home for ≥48 hours
- adverse comorbidities
Key exclusion criteria (1 listed)
- chronic or congenital diseases of the Central nervous, cardiovascular and bronchopulmonary systems
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 |
|---|---|---|
| Montelukast SodiumAlso: SingulairMontelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. | Drug | Group II |
| Placeboplacebo containing no active substance | Drug | Group I (control group) |
Primary outcome
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis
Time frame: up to 24 months
Children aged 1 to 7 years with recurrent obstructive bronchitis who will be treated in the Emergency Pediatrics and pediatric intensive care departments of the Emergency hospital of Samarkand will be examined. Patients will be randomly divided into 2 groups. Group I (control) will include 40 patients who received standard therapy and placebo. Group II will include 40 patients who received oral montelukast sodium in addition to standard therapy. Modified bronchophonography will be used to determine the effectiveness of the therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast Sodium in people with Acute Bronchiolitis, run by Samarkand State Medical Institute at 1 site in Uzbekistan.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis (time frame: up to 24 months). 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 3 Nov 2020.