Bronchial AsthmaPhase 3MontelukastNCT00565955
Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
A Phase 3 study testing montelukast in people with Bronchial Asthma, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Oct 2008
- Phase
- Phase 3
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute moderate to severe asthma is defined as modified pulmonary index score of more than 9.
Who cannot join
- Children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium).
- Children who had received montelukast within one week of arrival.
- Children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma.
- Children with altered sensorium/unable to take oral medication.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi
About this study
Official title: Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
HYPOTHESIS:
Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.
Read the detailed description
Leukotrienes plays an important role as mediator for inflammatory changes in acute as well as chronic asthma. There are three randomized controlled trials involving 274 adult patients with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and oral in one study) to see the beneficial response in spirometry. All the studies showed significant improvement in FEV1 in first 2 hours. These studies show that oral montelukast causes improved pulmonary function and has a rapid onset of action. However, these studies are carried out in adults. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, we planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
- Conditions
- Bronchial Asthma
- Being tested
- montelukast, Placebo
- Keywords
- Montelukast, Acute Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
Standard case management will be carried out as per guidelines given by British Thoracic Society. All patients will receive montelukast or similar looking placebo tablets. The doses of montelukast will be as follows:
5-12 years: 5 mg chewable tablet of montelukast; > 12 years: 10 mg chewable tablet of montelukast. Study drug will be administered at time of administration of steroid.
PlaceboDrug
The patients will receive placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Children Between 5-15 Years of Age Receiving Montelukast Receives: Drug: montelukast |
| A2 | Placebo comparator | Children Between 5-15 Years of Age Receiving Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.
Measured: 4 hours
Secondary outcomes (3)
Change in FEV1 at the end of 4 hours
Measured: 4 hours
Adverse effects: Headache, nausea, vomiting, abdominal pain
Measured: 4 hours
Need for hospitalization
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- SUSHIL K KABRA, Study director, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565955
- Sponsor's protocol ID
- vivek
- Acronym
- Montelukast
- Status last verified
- Nov 2008
- First submitted
- 29 Nov 2007
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Todi VK, Lodha R, Kabra SK. Effect of addition of single dose of oral montelukast to standard treatment in acute moderate to severe asthma in children between 5 and 15 years of age: a randomised, double-blind, placebo controlled trial. Arch Dis Child. 2010 Jul;95(7):540-3. doi: 10.1136/adc.2009.168567. Epub 2010 Jun 3.
PubMed 20522464
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00565955
- Acronym / sponsor ID
- Montelukast / vivek
- Conditions
- Bronchial Asthma
- Keywords
- Montelukast, Acute Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Nov 2007 (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.
Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
HYPOTHESIS:
Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.
Detailed description
Leukotrienes plays an important role as mediator for inflammatory changes in acute as well as chronic asthma. There are three randomized controlled trials involving 274 adult patients with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and oral in one study) to see the beneficial response in spirometry. All the studies showed significant improvement in FEV1 in first 2 hours. These studies show that oral montelukast causes improved pulmonary function and has a rapid onset of action. However, these studies are carried out in adults. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, we planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
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 |
|---|---|---|
| A1 | Active comparator | Drug: montelukastChildren Between 5-15 Years of Age Receiving Montelukast |
| A2 | Placebo comparator | Drug: PlaceboChildren Between 5-15 Years of Age Receiving Placebo |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute moderate to severe asthma is defined as modified pulmonary index score of more than 9.
Key exclusion criteria (4 listed)
- Children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium).
- Children who had received montelukast within one week of arrival.
- Children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma.
- Children with altered sensorium/unable to take oral medication.
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 |
|---|---|---|
| montelukastStandard case management will be carried out as per guidelines given by British Thoracic Society. All patients will receive montelukast or similar looking placebo tablets. The doses of montelukast will be as follows: 5-12 years: 5 mg chewable tablet of montelukast; > 12 years: 10 mg chewable tablet of montelukast. Study drug will be administered at time of administration of steroid. | Drug | A1 |
| PlaceboThe patients will receive placebo tablets. | Drug | A2 |
Primary outcome
Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.
Time frame: 4 hours
3 secondary outcomes
Change in FEV1 at the end of 4 hours
Time frame: 4 hours
Adverse effects: Headache, nausea, vomiting, abdominal pain
Time frame: 4 hours
Need for hospitalization
Time frame: 4 hours
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 14 Nov 2008.
- Derived from this study: PubMed 20522464Todi VK, Lodha R, Kabra SK. Effect of addition of single dose of oral montelukast to standard treatment in acute moderate to severe asthma in children between 5 and 15 years of age: a randomised, double-blind, placebo controlled trial. Arch Dis Child. 2010 Jul;95(7):540-3. doi: 10.1136/adc.2009.168567. Epub 2010 Jun 3.
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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.
SUSHIL K KABRA study director
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing montelukast in people with Bronchial Asthma, run by All India Institute of Medical Sciences at 1 site in India.
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 1 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 14 Nov 2008. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565955, which also lists 1 linked publication.
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 14 Nov 2008.