AsthmaPhase 4NCT01304901
Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.
A Phase 4 study testing montelukast 4 mg granule in people with Asthma and Acute Asthma, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Asthma, Acute Asthma
- What is being tested?
- montelukast 4 mg granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2010to Dec 2010
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 months to 6 years of age
- With at least three episodes of wheezing in the previous 12 months
- Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13
Who cannot join
- Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
- Who had any change in their dose of ICSs in the past 2 months
- Who had taken systemic corticosteroid within 1 months
- Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kecioren Education and Training Hospital
Ankara, Keçiören, 06290
About this study
Official title: Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.
Read the detailed description
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.
- Conditions
- Asthma, Acute Asthma
- Being tested
- montelukast 4 mg granule, Montelukast placebo granüle
- Keywords
- Acute asthma, Children, Montelukast, Emergency room
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast 4 mg granuleDrug
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
Montelukast placebo granüleDrug
Also called Montelukast placebo granule
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
| Study group | Role | What they receive |
|---|---|---|
| 1-Montelukast | Active comparator | Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids. Receives: Drug: montelukast 4 mg granule |
| 2- Placebo | Placebo comparator | Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids. Receives: Drug: Montelukast placebo granüle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of pulmonary index score from baseline to 120 minutes.
İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.
Measured: 0 to 120 minutes
Secondary outcomes (1)
Proportion of discharge from emergency department.
Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups.
Measured: 120, 180 and 240. minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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 RAZİ, M.D., Study director, Kecioren Education and Training HospitalELİF YAĞLI ÇOLAKOĞLU, M.D., Principal investigator, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304901
- Sponsor's protocol ID
- B.10.0.İEG-0.15-00-01/5181
- Status last verified
- Dec 2011
- First submitted
- 25 Feb 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
- ClinicalTrials.gov ID
- NCT01304901
- Acronym / sponsor ID
- B.10.0.İEG-0.15-00-01/5181
- Conditions
- Asthma, Acute Asthma
- Keywords
- Acute asthma, Children, Montelukast, Emergency room
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Feb 2011 (estimated)
- 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 purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.
Detailed description
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Montelukast | Active comparator | Drug: montelukast 4 mg granuleChildren had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids. |
| 2- Placebo | Placebo comparator | Drug: Montelukast placebo granüleChildren had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 months to 6 years of age
- With at least three episodes of wheezing in the previous 12 months
- Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13
Key exclusion criteria (4 listed)
- Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
- Who had any change in their dose of ICSs in the past 2 months
- Who had taken systemic corticosteroid within 1 months
- Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
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 granuleChildren had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids. | Drug | 1-Montelukast |
| Montelukast placebo granüleAlso: Montelukast placebo granuleChildren had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids. | Drug | 2- Placebo |
Primary outcome
Difference of pulmonary index score from baseline to 120 minutes.
Time frame: 0 to 120 minutes
İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.
1 secondary outcome
Proportion of discharge from emergency department.
Time frame: 120, 180 and 240. minutes
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 20 Dec 2011.
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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 RAZİ, M.D. study director
Kecioren Education and Training Hospital
ELİF YAĞLI ÇOLAKOĞLU, M.D. principal investigator
Kecioren Education and Training Hospital
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 granule in people with Asthma and Acute Asthma, 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 4 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 20 Dec 2011. 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?
Difference of pulmonary index score from baseline to 120 minutes. (time frame: 0 to 120 minutes). 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 20 Dec 2011.