Acute AsthmaPhase 4NCT03369119
Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children
A Phase 4 study testing Montelukast 4 Mg Oral Granule in people with Acute Asthma and Acute Wheezy Bronchitis, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Acute Asthma, Acute Wheezy Bronchitis
- What is being tested?
- Montelukast 4 Mg Oral Granule
- 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 siteTurkey (Türkiye)
- Study dates
- Aug 2011to Dec 2012
- 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 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medical history of at least 4 wheezing attacks
- Children with the ages of 6-60 months
- Children whose parents accept to give written informed consent
Who cannot join
- Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
- Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kecioren Education and Training Hospital
Ankara, Keçiören, 06380
About this study
Official title: Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations.
The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.
Read the detailed description
Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.
Objective: To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.
- Conditions
- Acute Asthma, Acute Wheezy Bronchitis
- Being tested
- Montelukast 4 Mg Oral Granule, Placebos
- Keywords
- Acute asthma, Montelukast, Hospitalized children, Preschool children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 4 Mg Oral GranuleDrug
Also called Montelukast sodium
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | Children received 4 mg oral montelukast granule daily until discharge. Receives: Drug: Montelukast 4 Mg Oral Granule |
| Placebo | Placebo comparator | Children receive 4 mg oral placebo montelukast granule daily until discharge Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.
Measured: within the 5 days from hospitalization
Secondary outcomes (1)
Difference in clinical asthma score
Improvement of clinical asthma scores between the 2 groups within 72 hours
Measured: Within 72 hours from hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study startAug 2011
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AsthmaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cem Hasan Razi, Kecioren Education and Training Hospital
- Investigators
- Cem H. Razi, M.D., Principal investigator, Pediatric Allergy Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369119
- Sponsor's protocol ID
- B.10.0.İEG.0.11.00.01/003247
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
- ClinicalTrials.gov ID
- NCT03369119
- Acronym / sponsor ID
- B.10.0.İEG.0.11.00.01/003247
- Conditions
- Acute Asthma, Acute Wheezy Bronchitis
- Keywords
- Acute asthma, Montelukast, Hospitalized children, Preschool children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Dec 2017 (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.
Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations.
The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.
Detailed description
Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.
Objective: To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: Montelukast 4 Mg Oral GranuleChildren received 4 mg oral montelukast granule daily until discharge. |
| Placebo | Placebo comparator | Drug: PlacebosChildren receive 4 mg oral placebo montelukast granule daily until discharge |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Medical history of at least 4 wheezing attacks
- Children with the ages of 6-60 months
- Children whose parents accept to give written informed consent
Key exclusion criteria (2 listed)
- Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
- Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)
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 4 Mg Oral GranuleAlso: Montelukast sodium | Drug | Montelukast |
| Placebos | Drug | Placebo |
Primary outcome
Length of hospital stay
Time frame: within the 5 days from hospitalization
The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.
1 secondary outcome
Difference in clinical asthma score
Time frame: Within 72 hours from hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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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.
Cem H. Razi, M.D. principal investigator
Pediatric Allergy Specialist
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 4 Mg Oral Granule in people with Acute Asthma and Acute Wheezy Bronchitis, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 11 Dec 2017. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of hospital stay (time frame: within the 5 days from hospitalization). 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 11 Dec 2017.