AsthmaPhase 4NCT02584738
Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation
A Phase 4 study testing Nebulized Magnesium Sulfate, Nebulized isotonic saline and Nebulized Salbutamol in people with Asthma, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
Trial summary
The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate in patient with moderate to severe asthma exacerbation in pediatric emergency Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nebulized Magnesium Sulfate, Nebulized isotonic saline and Nebulized Salbutamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2015to Jan 2018
- Phase
- Phase 4
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of moderate or severe asthma exacerbations
- 2 to 15 years old.
- Served in the pediatric emergency department of naval high specialty General Hospital from September to December 2015.
- Signing the consent by the parents.
Who cannot join
- Coexistence of lung disease.
- Severe kidney disease.
- Severe liver disease.
- Pregnancy.
- Known previous reaction to magnesium.
- Parents who have not signed the agreement.
Show all 12Show fewer
- Patients without a clinical history of asthma.
- Clinical diagnosis of mild asthma attack.
- Previously included in the study.
- Presence of comorbidities that endanger the patient's life.
- The patient has clinical or gasometric criteria for advanced airway management.
- Life-threatening symptoms.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General Naval de Alta Especialidad
Mexico City, Mexico City, 04480
Jesús Abisai Uicab Saucedo, Pediatrician, (52)5550371200 ext. 5423, abisaipec@msn.com
About this study
Official title: Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial
The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate in patient with moderate to severe asthma exacerbation in pediatric emergency
Read the detailed description
The inclusion period of the patients in this research will be on September 2015 to November 2015. Patients are going to be selected by the medical staff on duty in the emergency paediatric service, according to the criteria previously established inclusion and exclusion. Immediately a baseline degree of respiratory distress using PRAM scale and heart rate, respiratory rate, blood pressure and oxygen saturation. While informed consent in which the objective and characteristics of the study will be obtained will be explained.
Patients will be randomly assigned one of the two treatments in the Research: standard treatment for moderate to severe asthma attack, according to GINA or standard treatment plus nebulised magnesium sulphate, according to the table of random allocation of treatment.
Evaluations were performed after administration of each spray, that is, at 20, 40, 60, 120, 180 and 240 minutes after beginning treatment. The parameters' to evaluate are going to be heart rate, respiratory rate, oxygen saturation, blood pressure and assessment of severity of acute asthma with PRAM scale.
The application of nebulized drugs are made in the emergency department of pediatrics by inhalation therapy staff who are also responsible for the preparation of medicines. It is clear that this staff not participate in the evaluation of patients, which will be performed by the research staff or by medical staff on duty in the pediatric emergency department.
Patients and evaluating physician will not pick out between the two solutions for nebulization not only colour but also smell or other special feature, because the solutions were arranged in two identical syringes. Administered alone at the end of the study treatment is known.
Later the entry or exit of the patient decide, who can be egress to show clinical improvement with decreased severity index PRAM, patients will be graduates of an outpatient treatment according to international guidelines on the management of acute asthma. All initial and outcome data will be recorded in a format of data collection All decisions will be made by patients pediatricians emergency department which will follow patients throughout the study and will have the power to release the study patients to use other interventions that they consider clinically necessary
- Conditions
- Asthma
- Being tested
- Nebulized Magnesium Sulfate, Nebulized isotonic saline, Nebulized Salbutamol, Ipratropium bromide, Methylprednisolone or Prednisolone
- Keywords
- Asthma, Exacerbation, Nebulization, Magnesium, Pediatric
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized Magnesium SulfateDrug
Also called MgSO4
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4 (150 mg) per dose every 20 minutes during the first hour.
will be continued with nebulized standard treatment every hour for 4 hours.
Nebulized isotonic salineDrug
Also called Standard treatment
Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic saline per dose every 20 minutes during the first hour.
will be continued with nebulized standard treatment every hour for 4 hours.
Nebulized SalbutamolDrug
Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
Ipratropium bromideDrug
Nebulized ipratropium bromide 250 mcg
Methylprednisolone or PrednisoloneDrug
Also called Corticosteroid therapy
Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Magnesium Sulfate | Experimental | Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4.
Intravenous methylprednisolone or oral prednisolone Receives: Drug: Nebulized Magnesium Sulfate; Drug: Nebulized Salbutamol; Drug: Ipratropium bromide; Drug: Methylprednisolone or Prednisolone |
| Nebulized isotonic saline | Placebo comparator | Nebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone Receives: Drug: Nebulized isotonic saline; Drug: Nebulized Salbutamol; Drug: Ipratropium bromide; Drug: Methylprednisolone or Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Preschool Respiratory Assessment Measure (PRAM)
Scalene muscle contraction, Suprasternal retractions, Wheezing, Air entry and O2 saturation.
The score will be considering from the addition per each primary measure.
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Scalene muscle contraction
Absent (0) or Present (2)
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Suprasternal retractions
Absent (0) or Present (2)
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Wheezing
Normal (0), Decreased at bases (1), Widespread decrease (2), or Absent/minimal (3)
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Air entry
Absent (0), Expiratory only (1), Inspiratory and expiratory (2) or Audible without (3) stethoscope/silent chest with minimal air entry
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline O2 saturation
≥95% (0), 92%-94% (1) or <92% (2)
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Secondary outcomes (4)
Rate of hospitalization
Reduction the rate of hospitalization
Measured: 4 hour
Change from Baseline Heart rate
Beats per minute
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Respiratory rate
Breaths per minute
Measured: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Blood pressure
mmHg
Measured: 60 minutes after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jesús Abisai Uicab Saucedo, Pediatrician, Principal investigator, Secretaria de Marina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584738
- Sponsor's protocol ID
- HGNAE-03
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Birken CS, Parkin PC, Macarthur C. Asthma severity scores for preschoolers displayed weaknesses in reliability, validity, and responsiveness. J Clin Epidemiol. 2004 Nov;57(11):1177-81. doi: 10.1016/j.jclinepi.2004.02.016.
PubMed 15567635Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.
PubMed 14709423Rodrigo GJ, Plaza Moral V, Forns SB, Castro-Rodriguez JA, de Diego Damia A, Cortes SL, Moreno CM, Nannini LJ, Neffen H, Salas J; SEPAR; ALAT. [ALERTA 2 guidelines. Latin America and Spain: recommendations for the prevention and treatment of asmatic exacerbations. Spanish Pulmonology and Thoracic Surgery Society (SEPAR). Asthma Department of the Latinamerican Thoracic Association (ALAT)]. Arch Bronconeumol. 2010 Oct;46 Suppl 7:2-20. doi: 10.1016/S0300-2896(10)70041-7. No abstract available. Spanish.
PubMed 21320808Gourgoulianis KI, Chatziparasidis G, Chatziefthimiou A, Molyvdas PA. Magnesium as a relaxing factor of airway smooth muscles. J Aerosol Med. 2001 Fall;14(3):301-7. doi: 10.1089/089426801316970259.
PubMed 11693841Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.
PubMed 9680494Cairns CB, Kraft M. Magnesium attenuates the neutrophil respiratory burst in adult asthmatic patients. Acad Emerg Med. 1996 Dec;3(12):1093-7. doi: 10.1111/j.1553-2712.1996.tb03366.x.
PubMed 8959161Mohammed S, Goodacre S. Intravenous and nebulised magnesium sulphate for acute asthma: systematic review and meta-analysis. Emerg Med J. 2007 Dec;24(12):823-30. doi: 10.1136/emj.2007.052050.
PubMed 18029512Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.
PubMed 23290189Powell C, Dwan K, Milan SJ, Beasley R, Hughes R, Knopp-Sihota JA, Rowe BH. Inhaled magnesium sulfate in the treatment of acute asthma. Cochrane Database Syst Rev. 2012 Dec 12;12:CD003898. doi: 10.1002/14651858.CD003898.pub5.
PubMed 23235599Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.
PubMed 24429154Powell 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 24144222Alansari 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 25652104Rowe BH. Intravenous and inhaled MgSO4 for acute asthma. Lancet Respir Med. 2013 Jun;1(4):276-7. doi: 10.1016/S2213-2600(13)70097-3. Epub 2013 May 17. No abstract available.
PubMed 24429139Petrou S, Boland A, Khan K, Powell C, Kolamunnage-Dona R, Lowe J, Doull I, Hood K, Williamson P. Economic evaluation of nebulized magnesium sulphate in acute severe asthma in children. Int J Technol Assess Health Care. 2014 Oct;30(4):354-60. doi: 10.1017/S0266462314000440. Epub 2014 Nov 14.
PubMed 25394502Wang H, Xiong Y, Gong C, Yin L, Yan L, Yuan X, Liu S, Shi T, Dai J. Effect of inhaled magnesium sulfate on bronchial hyperresponsiveness. Indian J Pediatr. 2015 Apr;82(4):321-7. doi: 10.1007/s12098-014-1476-6. Epub 2014 Jun 12.
PubMed 24916134
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02584738
- Acronym / sponsor ID
- HGNAE-03
- Conditions
- Asthma
- Keywords
- Asthma, Exacerbation, Nebulization, Magnesium, Pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico NavalOther government
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 23 Oct 2015 (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 purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate in patient with moderate to severe asthma exacerbation in pediatric emergency
Detailed description
The inclusion period of the patients in this research will be on September 2015 to November 2015. Patients are going to be selected by the medical staff on duty in the emergency paediatric service, according to the criteria previously established inclusion and exclusion. Immediately a baseline degree of respiratory distress using PRAM scale and heart rate, respiratory rate, blood pressure and oxygen saturation. While informed consent in which the objective and characteristics of the study will be obtained will be explained.
Patients will be randomly assigned one of the two treatments in the Research: standard treatment for moderate to severe asthma attack, according to GINA or standard treatment plus nebulised magnesium sulphate, according to the table of random allocation of treatment.
Evaluations were performed after administration of each spray, that is, at 20, 40, 60, 120, 180 and 240 minutes after beginning treatment. The parameters' to evaluate are going to be heart rate, respiratory rate, oxygen saturation, blood pressure and assessment of severity of acute asthma with PRAM scale.
The application of nebulized drugs are made in the emergency department of pediatrics by inhalation therapy staff who are also responsible for the preparation of medicines. It is clear that this staff not participate in the evaluation of patients, which will be performed by the research staff or by medical staff on duty in the pediatric emergency department.
Patients and evaluating physician will not pick out between the two solutions for nebulization not only colour but also smell or other special feature, because the solutions were arranged in two identical syringes. Administered alone at the end of the study treatment is known.
Later the entry or exit of the patient decide, who can be egress to show clinical improvement with decreased severity index PRAM, patients will be graduates of an outpatient treatment according to international guidelines on the management of acute asthma. All initial and outcome data will be recorded in a format of data collection All decisions will be made by patients pediatricians emergency department which will follow patients throughout the study and will have the power to release the study patients to use other interventions that they consider clinically necessary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Magnesium Sulfate | Experimental | Drug: Nebulized Magnesium Sulfate, Drug: Nebulized Salbutamol, Drug: Ipratropium bromide, Drug: Methylprednisolone or PrednisoloneNebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4. Intravenous methylprednisolone or oral prednisolone |
| Nebulized isotonic saline | Placebo comparator | Drug: Nebulized isotonic saline, Drug: Nebulized Salbutamol, Drug: Ipratropium bromide, Drug: Methylprednisolone or PrednisoloneNebulized salbutamol and ipratropium bromide with 2.5 ml of isotonic saline. Intravenous methylprednisolone or oral prednisolone |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of moderate or severe asthma exacerbations
- 2 to 15 years old.
- Served in the pediatric emergency department of naval high specialty General Hospital from September to December 2015.
- Signing the consent by the parents.
Key exclusion criteria (12 listed)
- Coexistence of lung disease.
- Severe kidney disease.
- Severe liver disease.
- Pregnancy.
- Known previous reaction to magnesium.
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 |
|---|---|---|
| Nebulized Magnesium SulfateAlso: MgSO4Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4 (150 mg) per dose every 20 minutes during the first hour. will be continued with nebulized standard treatment every hour for 4 hours. | Drug | Nebulized Magnesium Sulfate |
| Nebulized isotonic salineAlso: Standard treatmentNebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic saline per dose every 20 minutes during the first hour. will be continued with nebulized standard treatment every hour for 4 hours. | Drug | Nebulized isotonic saline |
| Nebulized SalbutamolNebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years) | Drug | Nebulized Magnesium Sulfate, Nebulized isotonic saline |
| Ipratropium bromideNebulized ipratropium bromide 250 mcg | Drug | Nebulized Magnesium Sulfate, Nebulized isotonic saline |
| Methylprednisolone or PrednisoloneAlso: Corticosteroid therapyBegin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment | Drug | Nebulized Magnesium Sulfate, Nebulized isotonic saline |
Primary outcome
Change from Baseline Preschool Respiratory Assessment Measure (PRAM)
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Scalene muscle contraction, Suprasternal retractions, Wheezing, Air entry and O2 saturation. The score will be considering from the addition per each primary measure.
Change from Baseline Scalene muscle contraction
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Absent (0) or Present (2)
Change from Baseline Suprasternal retractions
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Absent (0) or Present (2)
Change from Baseline Wheezing
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Normal (0), Decreased at bases (1), Widespread decrease (2), or Absent/minimal (3)
Change from Baseline Air entry
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Absent (0), Expiratory only (1), Inspiratory and expiratory (2) or Audible without (3) stethoscope/silent chest with minimal air entry
Change from Baseline O2 saturation
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
≥95% (0), 92%-94% (1) or <92% (2)
4 secondary outcomes
Rate of hospitalization
Time frame: 4 hour
Change from Baseline Heart rate
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Respiratory rate
Time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning treatment
Change from Baseline Blood pressure
Time frame: 60 minutes after beginning treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 15567635Birken CS, Parkin PC, Macarthur C. Asthma severity scores for preschoolers displayed weaknesses in reliability, validity, and responsiveness. J Clin Epidemiol. 2004 Nov;57(11):1177-81. doi: 10.1016/j.jclinepi.2004.02.016.
- Background: PubMed 14709423Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.
- Background: PubMed 21320808Rodrigo GJ, Plaza Moral V, Forns SB, Castro-Rodriguez JA, de Diego Damia A, Cortes SL, Moreno CM, Nannini LJ, Neffen H, Salas J; SEPAR; ALAT. [ALERTA 2 guidelines. Latin America and Spain: recommendations for the prevention and treatment of asmatic exacerbations. Spanish Pulmonology and Thoracic Surgery Society (SEPAR). Asthma Department of the Latinamerican Thoracic Association (ALAT)]. Arch Bronconeumol. 2010 Oct;46 Suppl 7:2-20. doi: 10.1016/S0300-2896(10)70041-7. No abstract available. Spanish.
- Background: PubMed 11693841Gourgoulianis KI, Chatziparasidis G, Chatziefthimiou A, Molyvdas PA. Magnesium as a relaxing factor of airway smooth muscles. J Aerosol Med. 2001 Fall;14(3):301-7. doi: 10.1089/089426801316970259.
- Background: PubMed 9680494Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.
- Background: PubMed 8959161Cairns CB, Kraft M. Magnesium attenuates the neutrophil respiratory burst in adult asthmatic patients. Acad Emerg Med. 1996 Dec;3(12):1093-7. doi: 10.1111/j.1553-2712.1996.tb03366.x.
- Background: PubMed 18029512Mohammed S, Goodacre S. Intravenous and nebulised magnesium sulphate for acute asthma: systematic review and meta-analysis. Emerg Med J. 2007 Dec;24(12):823-30. doi: 10.1136/emj.2007.052050.
- Background: PubMed 23290189Shan Z, Rong Y, Yang W, Wang D, Yao P, Xie J, Liu L. Intravenous and nebulized magnesium sulfate for treating acute asthma in adults and children: a systematic review and meta-analysis. Respir Med. 2013 Mar;107(3):321-30. doi: 10.1016/j.rmed.2012.12.001. Epub 2013 Jan 3.
- Background: PubMed 23235599Powell C, Dwan K, Milan SJ, Beasley R, Hughes R, Knopp-Sihota JA, Rowe BH. Inhaled magnesium sulfate in the treatment of acute asthma. Cochrane Database Syst Rev. 2012 Dec 12;12:CD003898. doi: 10.1002/14651858.CD003898.pub5.
- Background: PubMed 24429154Goodacre S, Cohen J, Bradburn M, Gray A, Benger J, Coats T; 3Mg Research Team. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Jun;1(4):293-300. doi: 10.1016/S2213-2600(13)70070-5. Epub 2013 May 17.
- 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 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.
- Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (Updated 2015).Link provided by the sponsor.
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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.
Jesús Abisai Uicab Saucedo, Pediatrician principal investigator
Secretaria de Marina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized Magnesium Sulfate, Nebulized isotonic saline and Nebulized Salbutamol in people with Asthma, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
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 12 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesús Abisai Uicab Saucedo, Pediatrician ((52)5550371200 ext. 5423, abisaipec@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Preschool Respiratory Assessment Measure (PRAM) (time frame: 20, 40, 60, 120, 180 and 240 minutes after beginning 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 NCT02584738, which also lists 17 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 2 Dec 2015.