Status AsthmaticusPhase 1NCT04929626
Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus
A Phase 1 study testing Magnesium Sulfate 500 mg/ml+ ventolin and Ventolin in people with Status Asthmaticus, run by Ziauddin University at 1 site in Pakistan.
Trial summary
In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- Magnesium Sulfate 500 mg/ml+ ventolin and Ventolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 12 Nov 2022
- Phase
- Phase 1
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 2 to 12 years of age.
- Children with the diagnosis of asthma having a pram score of more than 4.
- Children with reactive airways
Who cannot join
- Critically ill children who require intubation or mechanical ventilation.
- Having hypersensitivity or allergy to MgSO4.
- with history of chronic lung impairment.
- Whose parents are not giving informed consent for participation in research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus
In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.
Read the detailed description
This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.
- Conditions
- Status Asthmaticus
- Being tested
- Magnesium Sulfate 500 mg/ml+ ventolin, Ventolin
- Keywords
- asthma, nebulized, magnesium sulphate
- Medical subject headings
- Status Asthmaticus, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 500 mg/ml+ ventolinDrug
Also called MgSO4
3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form
VentolinDrug
Also called Salbutamol
it will be given to control group in nebulized form after every 20 min in 1st hour
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Ventolin | Active comparator | Nebulized Ventolin will given to 1st group after every 20 min for 1 hour Receives: Drug: Ventolin |
| Nebulized Magnesium Sulphate + Ventolin | Experimental | Dose of Nebulized Magnesium sulphate will vary in 3 subgroups. Receives: Drug: Magnesium Sulfate 500 mg/ml+ ventolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
The outcome measure was the response to treatment in terms of change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline, i.e; suprasternal indrawing, scalene retractions, wheezing, air entry, oxygen saturation on room air. Change in PRAM score means decrease in score i.e; mild (0-4), moderate (5-8), severe(9-12), impending respiratory failure (12+).
Measured: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Suprasternal indrawing
Absent (0) , Present (2)
Measured: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Scalene retractions
Absent (0) , Present (2)
Measured: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Wheezing
Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry
Measured: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Air entry
Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3)
Measured: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Change from baseline Oxygen saturation on room air
>93% (0), 90%-93% (1) or <90% (2)
Measured: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Secondary outcomes (2)
Hospital stay
curtailment in the length of hospital stay
Measured: 24 hours
Hospital stay
curtailment in the length of hospital stay
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jan 2022
- Primary completion12 Nov 2022
- Study completion12 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Status AsthmaticusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Rabia Asif, Ziauddin University
- Investigators
- Rabia Asif, MBBS, PGT, Principal investigator, Ziauddin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929626
- Sponsor's protocol ID
- Doses of Nebulized MgSO4
- Status last verified
- Apr 2023
- First submitted
- 10 May 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
PubMed 25652104Mustafa J, Iqbal SMJ, Azhar IA, Sultan MA. Nebulized magnesium sulphate as an adjunct therapy in the management of children presenting with acute exacerbation of asthma. Pakistan J Med Heal Sci. 2018;12(2):554-5.
Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.
PubMed 27996280Turker S, Dogru M, Yildiz F, Yilmaz SB. The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatment. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):115-120. doi: 10.1016/j.aller.2016.10.003. Epub 2017 Jan 31.
PubMed 28153353Sarhan HA, El-Garhy OH, Ali MA, Youssef NA. The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthma. Drug Des Devel Ther. 2016 Jun 9;10:1927-33. doi: 10.2147/DDDT.S103147. eCollection 2016.
PubMed 27354766Schuh S, Sweeney J, Freedman SB, Coates AL, Johnson DW, Thompson G, Gravel J, Ducharme FM, Zemek R, Plint AC, Beer D, Klassen T, Curtis S, Black K, Nicksy D, Willan AR; Pediatric Emergency Research Canada Group. Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial. Trials. 2016 May 24;17(1):261. doi: 10.1186/s13063-015-1151-x.
PubMed 27220675Kew KM, Kirtchuk L, Michell CI. Intravenous magnesium sulfate for treating adults with acute asthma in the emergency department. Cochrane Database Syst Rev. 2014 May 28;2014(5):CD010909. doi: 10.1002/14651858.CD010909.pub2.
PubMed 24865567Akter T, Islam N, Hoque MA, Khanam S, Saha BK. Original Article Nebulization by Isotonic Magnesium Sulphate Solution with Salbutamol Provide Early and Better Response as Compared to Conventional Approach ( Salbutamol Plus Normal Saline ) in Acute Exacerbation of Asthma in Children . 2014;9(2):61-7.
Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.
PubMed 24144222Hendaus MA, Jomha FA, Alhammadi AH. Is ketamine a lifesaving agent in childhood acute severe asthma? Ther Clin Risk Manag. 2016 Feb 22;12:273-9. doi: 10.2147/TCRM.S100389. eCollection 2016.
PubMed 26955277Dexheimer JW, Abramo TJ, Arnold DH, Johnson KB, Shyr Y, Ye F, Fan KH, Patel N, Aronsky D. An asthma management system in a pediatric emergency department. Int J Med Inform. 2013 Apr;82(4):230-8. doi: 10.1016/j.ijmedinf.2012.11.006. Epub 2012 Dec 4.
PubMed 23218449Kumar A. Effectiveness of Nebulized Magnesium Sulphate as an Adjuvant Therapy (With Salbutamol) in the Management of Acute Asthma. Pakistan J Med Dent. 2020;9(02):39-44.
Reddel HK, Bateman ED, Becker A, Boulet LP, Cruz AA, Drazen JM, Haahtela T, Hurd SS, Inoue H, de Jongste JC, Lemanske RF Jr, Levy ML, O'Byrne PM, Paggiaro P, Pedersen SE, Pizzichini E, Soto-Quiroz M, Szefler SJ, Wong GW, FitzGerald JM. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015 Sep;46(3):622-39. doi: 10.1183/13993003.00853-2015. Epub 2015 Jul 23.
PubMed 26206872Al-Shamrani A, Al-Harbi AS, Bagais K, Alenazi A, Alqwaiee M. Management of asthma exacerbation in the emergency departments. Int J Pediatr Adolesc Med. 2019 Jun;6(2):61-67. doi: 10.1016/j.ijpam.2019.02.001. Epub 2019 Mar 15. No abstract available.
PubMed 31388549Rehder KJ. Adjunct Therapies for Refractory Status Asthmaticus in Children. Respir Care. 2017 Jun;62(6):849-865. doi: 10.4187/respcare.05174.
PubMed 28546381
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Doses of Nebulized Magnesium Sulphate as an Adjuvant Treatment With Salbutamol in Children With Status Asthmaticus
- ClinicalTrials.gov ID
- NCT04929626
- Acronym / sponsor ID
- Doses of Nebulized MgSO4
- Conditions
- Status Asthmaticus
- Keywords
- asthma, nebulized, magnesium sulphate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 12 Nov 2022 (actual)
- First posted
- 18 Jun 2021 (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.
In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.
Detailed description
This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes
| Arm | Type | Receives |
|---|---|---|
| Nebulized Ventolin | Active comparator | Drug: VentolinNebulized Ventolin will given to 1st group after every 20 min for 1 hour |
| Nebulized Magnesium Sulphate + Ventolin | Experimental | Drug: Magnesium Sulfate 500 mg/ml+ ventolinDose of Nebulized Magnesium sulphate will vary in 3 subgroups. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 2 to 12 years of age.
- Children with the diagnosis of asthma having a pram score of more than 4.
- Children with reactive airways
Key exclusion criteria (4 listed)
- Critically ill children who require intubation or mechanical ventilation.
- Having hypersensitivity or allergy to MgSO4.
- with history of chronic lung impairment.
- Whose parents are not giving informed consent for participation in research.
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 Sulfate 500 mg/ml+ ventolinAlso: MgSO43 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form | Drug | Nebulized Magnesium Sulphate + Ventolin |
| VentolinAlso: Salbutamolit will be given to control group in nebulized form after every 20 min in 1st hour | Drug | Nebulized Ventolin |
Primary outcome
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
The outcome measure was the response to treatment in terms of change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline, i.e; suprasternal indrawing, scalene retractions, wheezing, air entry, oxygen saturation on room air. Change in PRAM score means decrease in score i.e; mild (0-4), moderate (5-8), severe(9-12), impending respiratory failure (12+).
Change from baseline Suprasternal indrawing
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0) , Present (2)
Change from baseline Scalene retractions
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0) , Present (2)
Change from baseline Wheezing
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Absent (0), Expiratory only (1), Inspiratory and expiratory (2) Audible without (3) stethoscope/silent chest with minimal air entry
Change from baseline Air entry
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
Normal (0), Decreased at bases (1), Widespread decrease (2), Absent/minimal (3)
Change from baseline Oxygen saturation on room air
Time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment
>93% (0), 90%-93% (1) or <90% (2)
2 secondary outcomes
Hospital stay
Time frame: 24 hours
Hospital stay
Time frame: 48 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 5 Apr 2023.
- Background: PubMed 25652104Alansari K, Ahmed W, Davidson BL, Alamri M, Zakaria I, Alrifaai M. Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial. Pediatr Pulmonol. 2015 Dec;50(12):1191-9. doi: 10.1002/ppul.23158. Epub 2015 Feb 4.
- BackgroundMustafa J, Iqbal SMJ, Azhar IA, Sultan MA. Nebulized magnesium sulphate as an adjunct therapy in the management of children presenting with acute exacerbation of asthma. Pakistan J Med Heal Sci. 2018;12(2):554-5.
- Background: PubMed 27996280Daengsuwan T, Watanatham S. A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthma. Asian Pac J Allergy Immunol. 2017 Jun;35(2):108-112. doi: 10.12932/AP0780.
- Background: PubMed 28153353Turker S, Dogru M, Yildiz F, Yilmaz SB. The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatment. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):115-120. doi: 10.1016/j.aller.2016.10.003. Epub 2017 Jan 31.
- Background: PubMed 27354766Sarhan HA, El-Garhy OH, Ali MA, Youssef NA. The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthma. Drug Des Devel Ther. 2016 Jun 9;10:1927-33. doi: 10.2147/DDDT.S103147. eCollection 2016.
- Background: PubMed 27220675Schuh S, Sweeney J, Freedman SB, Coates AL, Johnson DW, Thompson G, Gravel J, Ducharme FM, Zemek R, Plint AC, Beer D, Klassen T, Curtis S, Black K, Nicksy D, Willan AR; Pediatric Emergency Research Canada Group. Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial. Trials. 2016 May 24;17(1):261. doi: 10.1186/s13063-015-1151-x.
- Background: PubMed 24865567Kew KM, Kirtchuk L, Michell CI. Intravenous magnesium sulfate for treating adults with acute asthma in the emergency department. Cochrane Database Syst Rev. 2014 May 28;2014(5):CD010909. doi: 10.1002/14651858.CD010909.pub2.
- BackgroundAkter T, Islam N, Hoque MA, Khanam S, Saha BK. Original Article Nebulization by Isotonic Magnesium Sulphate Solution with Salbutamol Provide Early and Better Response as Compared to Conventional Approach ( Salbutamol Plus Normal Saline ) in Acute Exacerbation of Asthma in Children . 2014;9(2):61-7.
- Background: PubMed 24144222Powell CV, Kolamunnage-Dona R, Lowe J, Boland A, Petrou S, Doull I, Hood K, Williamson PR; MAGNETIC study group. MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children. Health Technol Assess. 2013 Oct;17(45):v-vi, 1-216. doi: 10.3310/hta17450.
- Background: PubMed 26955277Hendaus MA, Jomha FA, Alhammadi AH. Is ketamine a lifesaving agent in childhood acute severe asthma? Ther Clin Risk Manag. 2016 Feb 22;12:273-9. doi: 10.2147/TCRM.S100389. eCollection 2016.
- Background: PubMed 23218449Dexheimer JW, Abramo TJ, Arnold DH, Johnson KB, Shyr Y, Ye F, Fan KH, Patel N, Aronsky D. An asthma management system in a pediatric emergency department. Int J Med Inform. 2013 Apr;82(4):230-8. doi: 10.1016/j.ijmedinf.2012.11.006. Epub 2012 Dec 4.
- BackgroundKumar A. Effectiveness of Nebulized Magnesium Sulphate as an Adjuvant Therapy (With Salbutamol) in the Management of Acute Asthma. Pakistan J Med Dent. 2020;9(02):39-44.
- North American practice patterns of intravenous magnesium therapy in severe acute asthma in childrenLink provided by the sponsor.
- Nebulized magnesium for moderate and severe pediatric asthma: A randomized trialLink provided by the sponsor.
- A comparative pilot study of the efficacy and safety of nebulized magnesium sulfate and intravenous magnesium sulfate in children with severe acute asthmaLink provided by the sponsor.
- The effect of nebulised magnesium sulphate in the management of childhood moderate asthma exacerbations as adjuvant treatmentLink provided by the sponsor.
- The efficacy of nebulized magnesium sulfate alone and in combination with salbutamol in acute asthmaLink provided by the sponsor.
- Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rabia Asif, MBBS, PGT principal investigator
Ziauddin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnesium Sulfate 500 mg/ml+ ventolin and Ventolin in people with Status Asthmaticus, run by Ziauddin University 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 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 5 Apr 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the baseline (time frame: 20, 40, 60, 120, 360, 720, 1080, 1440 minutes after commencement of treatment). The study lists 6 primary outcomes in all. 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 NCT04929626, which also lists 22 linked publications.
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 5 Apr 2023.