BronchiolitisNCT01370187
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
A study testing Montelukast in people with Bronchiolitis and Wheezing, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Bronchiolitis, Wheezing, Cough
- What is being tested?
- Montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIran
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- 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 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infant in 3-12 months of age with first episode of wheezing or bronchiolitis
- written informed consent by parents
Who cannot join
- Previous wheezing episode or confirmed asthma or bronchiolitis
- recent bronchodilator use
- immune deficient
- immunosuppressive drug use
- croup or pneumonia diagnosis
- loss of follow up
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences (HUMS)
Bandar Abbas, Hormozgan, 79145-3388
About this study
Official title: Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital
The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
Read the detailed description
All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.
- Conditions
- Bronchiolitis, Wheezing, Cough
- Being tested
- Montelukast
- Keywords
- Bronchiolitis, Postbronchiolitis wheezing, Montelukast
- Medical subject headings
- Bronchiolitis, Respiratory Sounds, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Montelukast 4mg daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group |
| Montelukast | Experimental | 4mg Montelukast daily for 2 months Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Distress Severity Score (RDSS)
RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (2)
average number of cough daily= as expressed parents during visits
none= No cough, Mild=less than 10 daily, Severe=More than 10 daily
Measured: 6 months
Wheezing severity in the physical examination by physician
None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ali Asghar Parhiz, Resident, Principal investigator, Hormzgan University of Medical Sciences (HUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370187
- Sponsor's protocol ID
- Montelukast for bronchiolitis
- Status last verified
- Jun 2010
- First submitted
- 6 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital
- ClinicalTrials.gov ID
- NCT01370187
- Acronym / sponsor ID
- Montelukast for bronchiolitis
- Conditions
- Bronchiolitis, Wheezing, Cough
- Keywords
- Bronchiolitis, Postbronchiolitis wheezing, Montelukast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Jun 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 aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
Detailed description
All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group |
| Montelukast | Experimental | Drug: Montelukast4mg Montelukast daily for 2 months |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infant in 3-12 months of age with first episode of wheezing or bronchiolitis
- written informed consent by parents
Key exclusion criteria (6 listed)
- Previous wheezing episode or confirmed asthma or bronchiolitis
- recent bronchodilator use
- immune deficient
- immunosuppressive drug use
- croup or pneumonia diagnosis
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 |
|---|---|---|
| MontelukastMontelukast 4mg daily for 2 months | Drug | Montelukast |
Primary outcome
Respiratory Distress Severity Score (RDSS)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
2 secondary outcomes
average number of cough daily= as expressed parents during visits
Time frame: 6 months
Wheezing severity in the physical examination by physician
Time frame: 6 Months
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 Jun 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.
Ali Asghar Parhiz, Resident principal investigator
Hormzgan University of Medical Sciences (HUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast in people with Bronchiolitis and Wheezing, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 6 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 Jun 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 Iran. 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.
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?
Respiratory Distress Severity Score (RDSS) (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days). 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 14 Jun 2011.