Acute BronchiolitisPhase 2NCT07770464
Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis
A Phase 2 study testing Montelukast in people with Acute Bronchiolitis, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms Read more about this study
- Who is it for?
- Ages 4 weeks to 2 years
- Conditions the study is for
- Acute Bronchiolitis
- 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
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 4 weeks to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 weeks to 2 years
- Both genders
- Duration of respiratory symptoms less than 4 days
- Clinical diagnosis of acute bronchiolitis according to the operational definition provided in the study protocol
Who cannot join
- History of asthma
- Previous hospital admissions for respiratory illness
- Use of asthma medications
- Congenital heart disease
- Bronchopulmonary dysplasia
- Immunodeficiency
- Immunosuppression
- Radiological evidence of pneumonia, including infiltrates or patches on chest X-ray
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Medical Sciences, Islamabad
Islamabad, Federal, 44000
Dr Haniyah Anwar, M.B.B.S, +92334-8359647, haniyahanwar@yahoo.com
About this study
This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms
- Conditions
- Acute Bronchiolitis
- Being tested
- Montelukast, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Administrating montelukast to experimental group and monitoring response
PlaceboDrug
Placebo sugar granules administered orally once daily at night according to the same schedule as montelukast 4 mg sachet, in addition to standard supportive care for acute bronchiolitis
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | Participants will receive montelukast 4 mg sachet orally once daily at night in addition to standard supportive care for acute bronchiolitis. Receives: Drug: Montelukast |
| Control | Placebo comparator | Participants will receive placebo sugar granules orally once daily at night according to the same schedule as the montelukast group, in addition to standard supportive care for acute bronchiolitis Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Severity Score from Baseline to 72 Hours
Change in the study-defined Clinical Severity Score from baseline at hospital admission to 72 hours after initiation of treatment. The score ranges from 0 to 12 and is calculated from heart rate, wheezing, respiratory rate, dyspnea, respiratory support, and feeding difficulties, with each component scored from 0 to 2. Higher scores indicate greater clinical severity. The change in score will be compared between the montelukast and placebo groups
Measured: Baseline (hospital admission) and 72 hours after initiation of treatment
Secondary outcomes (1)
Length of Hospital Stay
Length of hospital stay measured in hours from hospital admission until hospital discharge. Discharge is defined by resolution of symptoms, including improved feeding, absence of respiratory distress, a clinical severity score less than 3, and respiratory rate within the normal range for age.
Measured: From baseline (hospital admission;day 1) through hospital discharge ( day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haniyah Anwar, Pakistan Institute of Medical Sciences
- Investigators
- Dr Haniyah Anwar, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770464
- Sponsor's protocol ID
- Bronchiolitis9699
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the primary research team because of participant privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT07770464
- Acronym / sponsor ID
- Bronchiolitis9699
- Conditions
- Acute Bronchiolitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Aug 2026 (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.
This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: MontelukastParticipants will receive montelukast 4 mg sachet orally once daily at night in addition to standard supportive care for acute bronchiolitis. |
| Control | Placebo comparator | Drug: PlaceboParticipants will receive placebo sugar granules orally once daily at night according to the same schedule as the montelukast group, in addition to standard supportive care for acute bronchiolitis |
Who may qualify
- Ages
- 4 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 4 weeks to 2 years
- Both genders
- Duration of respiratory symptoms less than 4 days
- Clinical diagnosis of acute bronchiolitis according to the operational definition provided in the study protocol
Key exclusion criteria (8 listed)
- History of asthma
- Previous hospital admissions for respiratory illness
- Use of asthma medications
- Congenital heart disease
- Bronchopulmonary dysplasia
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 |
|---|---|---|
| MontelukastAdministrating montelukast to experimental group and monitoring response | Drug | Montelukast |
| PlaceboPlacebo sugar granules administered orally once daily at night according to the same schedule as montelukast 4 mg sachet, in addition to standard supportive care for acute bronchiolitis | Drug | Control |
Primary outcome
Change in Clinical Severity Score from Baseline to 72 Hours
Time frame: Baseline (hospital admission) and 72 hours after initiation of treatment
Change in the study-defined Clinical Severity Score from baseline at hospital admission to 72 hours after initiation of treatment. The score ranges from 0 to 12 and is calculated from heart rate, wheezing, respiratory rate, dyspnea, respiratory support, and feeding difficulties, with each component scored from 0 to 2. Higher scores indicate greater clinical severity. The change in score will be compared between the montelukast and placebo groups
1 secondary outcome
Length of Hospital Stay
Time frame: From baseline (hospital admission;day 1) through hospital discharge ( day 7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the primary research team because of participant privacy and confidentiality considerations.
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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.
Dr Haniyah Anwar principal investigator
Pakistan 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 2 study testing Montelukast in people with Acute Bronchiolitis, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 8 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Haniyah Anwar, M.B.B.S (+92334-8359647, haniyahanwar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Severity Score from Baseline to 72 Hours (time frame: Baseline (hospital admission) and 72 hours after initiation of treatment). 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 18 Aug 2026.