Acute Exacerbation of AsthmaPhase 3NCT06626620
Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma
A Phase 3 study testing Magnesium Sulphate infusion and Terbutaline Infusion in people with Acute Exacerbation of Asthma, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Acute Exacerbation of Asthma
- What is being tested?
- Magnesium Sulphate infusion and Terbutaline Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Sep 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Known cases of asthma
- Minimum duration of asthma as 6 months
- Presenting with acute exacerbation of asthma
- Requiring emergency treatment.
Who cannot join
- Children having chronic respiratory diseases (cystic fibrosis, bronchopuonary dysplasia)
- Children with cardiac diseases
- Children who were hospitalized in the past 2-weeks due to any reasons
- Children using oral or intravenous corticosteroids or other systemic medications
- Children who were unable to undergo PEFR measurements due to any reasons
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.
Read the detailed description
Despite the established roles of both magnesium sulfate and terbutaline in the management of severe asthma exacerbations, there is limited comparative data on their efficacy and safety in the pediatric population. Understanding the relative benefits and risks of these therapies is crucial for optimizing treatment strategies and improving patient outcomes.
- Conditions
- Acute Exacerbation of Asthma
- Being tested
- Magnesium Sulphate infusion, Terbutaline Infusion
- Keywords
- Asthma, intravenous, magnesium sulfate, terbutaline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulphate infusionDrug
Also called IV MgSO4
Received IV magnesium sulfate (50 mg/kg up to a maximum dose of 2 g) administered over 20 minutes
Terbutaline InfusionDrug
Received IV terbutaline (10 mcg/kg bolus followed by a continuous infusion of 0.4 mcg/kg/min) for up to 4 hours
| Study group | Role | What they receive |
|---|---|---|
| IV Magnesium Sulfate | Experimental | Magnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells. Receives: Drug: Magnesium Sulphate infusion |
| IV Terbutaline | Experimental | Terbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective. Receives: Drug: Terbutaline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment PEFR
Post-treatment, children response to treatment was measured by noting PEFR
Measured: 4 hours
Secondary outcomes (3)
Oxygen Saturation
Post-treatment, oxygen saturation was measured using Spirometry
Measured: 4 hours
Heart Rate
Post-treatment, heart rate was measured
Measured: 4-hours
Respiratory rate
Post-treatment, heart rate was measured.
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 posted4 Oct 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 Acute Exacerbation of 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Collaborators
- Nishtar Medical University
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Arif Zulqarnain, FCPS, Study director, Department of Pediatrics, Nishtar Hospital, Multan, PakistanMuhammad Salman, FCPS, Principal investigator, Department of Pediatrics, Nishtar Hospital, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626620
- Sponsor's protocol ID
- NISHTARASTHMASTUDY
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zulqarnain A, Fayyaz A, Aziz MT, Zafar MS. Randomised controlled trial of intravenous magnesium sulfate versus terbutaline for children in the management of acute exacerbation of asthma. J Pak Med Assoc. 2026 Jul;76(7):1006-1010. doi: 10.47391/JPMA.22541.
PubMed 42444205
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma
- ClinicalTrials.gov ID
- NCT06626620
- Acronym / sponsor ID
- NISHTARASTHMASTUDY
- Conditions
- Acute Exacerbation of Asthma
- Keywords
- Asthma, intravenous, magnesium sulfate, terbutaline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Collaborators
- Nishtar Medical University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 Oct 2024 (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 aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.
Detailed description
Despite the established roles of both magnesium sulfate and terbutaline in the management of severe asthma exacerbations, there is limited comparative data on their efficacy and safety in the pediatric population. Understanding the relative benefits and risks of these therapies is crucial for optimizing treatment strategies and improving patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Magnesium Sulfate | Experimental | Drug: Magnesium Sulphate infusionMagnesium sulfate, a smooth muscle relaxant, has been shown to have bronchodilatory effects by inhibiting calcium influx into smooth muscle cells. |
| IV Terbutaline | Experimental | Drug: Terbutaline InfusionTerbutaline, a beta-2 agonist, is used intravenously to provide systemic bronchodilation when inhaled bronchodilators are not effective. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Known cases of asthma
- Minimum duration of asthma as 6 months
- Presenting with acute exacerbation of asthma
- Requiring emergency treatment.
Key exclusion criteria (5 listed)
- Children having chronic respiratory diseases (cystic fibrosis, bronchopuonary dysplasia)
- Children with cardiac diseases
- Children who were hospitalized in the past 2-weeks due to any reasons
- Children using oral or intravenous corticosteroids or other systemic medications
- Children who were unable to undergo PEFR measurements due to any reasons
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 |
|---|---|---|
| Magnesium Sulphate infusionAlso: IV MgSO4Received IV magnesium sulfate (50 mg/kg up to a maximum dose of 2 g) administered over 20 minutes | Drug | IV Magnesium Sulfate |
| Terbutaline InfusionReceived IV terbutaline (10 mcg/kg bolus followed by a continuous infusion of 0.4 mcg/kg/min) for up to 4 hours | Drug | IV Terbutaline |
Primary outcome
Post-treatment PEFR
Time frame: 4 hours
Post-treatment, children response to treatment was measured by noting PEFR
3 secondary outcomes
Oxygen Saturation
Time frame: 4 hours
Heart Rate
Time frame: 4-hours
Respiratory rate
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 4 Oct 2024.
- Derived from this study: PubMed 42444205Zulqarnain A, Fayyaz A, Aziz MT, Zafar MS. Randomised controlled trial of intravenous magnesium sulfate versus terbutaline for children in the management of acute exacerbation of asthma. J Pak Med Assoc. 2026 Jul;76(7):1006-1010. doi: 10.47391/JPMA.22541.
- Individual participant dataSharing planned: No
Related trials for Acute Exacerbation of Asthma
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
RecruitingPhase 2
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
Asthma Acute, Asthma Attack
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
Active, not recruiting
Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design
Asthma in Children
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.
Arif Zulqarnain, FCPS study director
Department of Pediatrics, Nishtar Hospital, Multan, Pakistan
Muhammad Salman, FCPS principal investigator
Department of Pediatrics, Nishtar Hospital, Multan
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 Magnesium Sulphate infusion and Terbutaline Infusion in people with Acute Exacerbation of Asthma, run by Muhammad Aamir Latif 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 5 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 4 Oct 2024. 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. 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?
Post-treatment PEFR (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 NCT06626620, 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 4 Oct 2024.