Childhood Asthma With Acute ExacerbationNCT06201156
Comparison of Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
A study testing Metered Dose Inhaler With Spacer Device in people with Childhood Asthma With Acute Exacerbation, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze Children will be… Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Childhood Asthma With Acute Exacerbation
- What is being tested?
- Metered Dose Inhaler With Spacer Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2023to 30 Mar 2024
- 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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6 to 24 months
- Patients of both gender
- Patients presenting to emergency department with bilateral wheeze
Who cannot join
- Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).
- Patients with history of congenital heart disease.
- Patients with history of intubation for longer than 1 week during the neonatal period.
- Patients having symptoms consistent with croup.
- Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze
Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.
For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.
- Conditions
- Childhood Asthma With Acute Exacerbation
- Being tested
- Metered Dose Inhaler With Spacer Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metered Dose Inhaler With Spacer DeviceDevice
Bronchodilator Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A / Nebulizer Group | Active comparator | Group A/ Nebulizer group will receive 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min. Receives: Device: Metered Dose Inhaler With Spacer Device |
| Group B / MDI with Spacer Device Group | Experimental | Group B/ MDI with Spacer Group will receive 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. Receives: Device: Metered Dose Inhaler With Spacer Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers
primary outcome is defined as Comparison of mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers with spacers for treatment of wheezing in children aged 6 to 24 months in a pediatric emergency department
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start10 Dec 2023
- Primary completion20 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Childhood Asthma With Acute ExacerbationStudies 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
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arooj Khan, Khyber Teaching Hospital
- Investigators
- Arooj Khan, MBBS, Principal investigator, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201156
- Sponsor's protocol ID
- 847/DME/KMC
- Status last verified
- Mar 2025
- First submitted
- 15 Dec 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Csonka P, Tapiainen T, Makela MJ, Lehtimaki L. Optimal administration of bronchodilators with valved holding chambers in preschool children: a review of literature. Eur J Pediatr. 2021 Oct;180(10):3101-3109. doi: 10.1007/s00431-021-04074-3. Epub 2021 Apr 20.
PubMed 33877400Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC.
PubMed 29323930Roncada C, Andrade J, Bischoff LC, Pitrez PM. COMPARISON OF TWO INHALATIONAL TECHNIQUES FOR BRONCHODILATOR ADMINISTRATION IN CHILDREN AND ADOLESCENTS WITH ACUTE ASTHMA CRISIS: A META-ANALYSIS. Rev Paul Pediatr. 2018 Jul-Sep;36(3):364-371. doi: 10.1590/1984-0462/;2018;36;3;00002. Epub 2018 Jul 10.
PubMed 29995144Alharbi AS, Yousef AA, Alharbi SA, Al-Shamrani A, Alqwaiee MM, Almeziny M, Said YS, Alshehri SA, Alotaibi FN, Mosalli R, Alawam KA, Alsaadi MM. Application of aerosol therapy in respiratory diseases in children: A Saudi expert consensus. Ann Thorac Med. 2021 Apr-Jun;16(2):188-218. doi: 10.4103/atm.atm_74_21. Epub 2021 Apr 17.
PubMed 34012486Payares-Salamanca L, Contreras-Arrieta S, Florez-Garcia V, Barrios-Sanjuanelo A, Stand-Nino I, Rodriguez-Martinez CE. Metered-dose inhalers versus nebulization for the delivery of albuterol for acute exacerbations of wheezing or asthma in children: A systematic review with meta-analysis. Pediatr Pulmonol. 2020 Dec;55(12):3268-3278. doi: 10.1002/ppul.25077. Epub 2020 Sep 25.
PubMed 32940961Schell DN, Durham D, Murphree SS, Muntz KH, Shaul PW. Ontogeny of beta-adrenergic receptors in pulmonary arterial smooth muscle, bronchial smooth muscle, and alveolar lining cells in the rat. Am J Respir Cell Mol Biol. 1992 Sep;7(3):317-24. doi: 10.1165/ajrcmb/7.3.317.
PubMed 1325812Dimino, K. Using A Metered Dose Inhaler (Mdi) With Spacer or Nebulizer for Managing Children Under 5 Years of Age with Exacerbation of Wheezing or Asthma. 2019; 11(2): 555815.10.19080/JOJNHC.2019.11.555815
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Index Score After Treatment With Salbutamol Through Nebulizers vs Metered-Dose Inhalers With Spacer Device For Treatment Of Childhood Wheeze
- ClinicalTrials.gov ID
- NCT06201156
- Acronym / sponsor ID
- 847/DME/KMC
- Conditions
- Childhood Asthma With Acute Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 11 Jan 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.
The goal of this randomized controlled trial is to compare two different devices for the administration of the standard protocol drug. The main question it aims to answer is are metered dose inhalers with spacer device as effective as nebulization with salbutamol in treatment of childhood wheeze
Children will be divided in two groups using block randomization method. Children in group A will be nebulizer group, treatment will consist of 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min.
For patients in group B spacer group, treatment consisted of 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. For administration of the MDI, the investigator will dispense I puff of salbutamol or placebo into the spacer and held the mask on the child's face while the child breathed 5 to 6 times through the mask. This process will b-e repeated for a total of 3 puffs per treatment. All patients will be treated by the principal investigator, at end of treatment need for admission and pulmonary index will be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A / Nebulizer Group | Active comparator | Device: Metered Dose Inhaler With Spacer DeviceGroup A/ Nebulizer group will receive 3 puffs of a placebo MDI with a spacer, followed immediately by a standard dose of 0.15 mg/kg of salbutamol in 3 mL of isotonic sodium chloride solution delivered by an oxygen-driven nebulizer at a flow rate of 6 L/min. |
| Group B / MDI with Spacer Device Group | Experimental | Device: Metered Dose Inhaler With Spacer DeviceGroup B/ MDI with Spacer Group will receive 3 puffs (90 pg per puff) of salbutamol MDI with a spacer, followed by 3 mL of nebulized isotonic sodium chloride solution. All treatments will be given at 20-minute intervals. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 6 to 24 months
- Patients of both gender
- Patients presenting to emergency department with bilateral wheeze
Key exclusion criteria (5 listed)
- Patients with history of chronic lung condition (including congenital anomalies, cystic fibrosis, and bronchopulmonary dysplasia).
- Patients with history of congenital heart disease.
- Patients with history of intubation for longer than 1 week during the neonatal period.
- Patients having symptoms consistent with croup.
- Patients with signs of impending respiratory failure i.e Pulmonary index score of 12.
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 |
|---|---|---|
| Metered Dose Inhaler With Spacer DeviceBronchodilator Therapy | Device | Group A / Nebulizer Group, Group B / MDI with Spacer Device Group |
Primary outcome
compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers
Time frame: 1 hour
primary outcome is defined as Comparison of mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers with spacers for treatment of wheezing in children aged 6 to 24 months in a pediatric emergency department
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 11 Mar 2025.
- Background: PubMed 33877400Csonka P, Tapiainen T, Makela MJ, Lehtimaki L. Optimal administration of bronchodilators with valved holding chambers in preschool children: a review of literature. Eur J Pediatr. 2021 Oct;180(10):3101-3109. doi: 10.1007/s00431-021-04074-3. Epub 2021 Apr 20.
- Background: PubMed 29323930Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC.
- Background: PubMed 29995144Roncada C, Andrade J, Bischoff LC, Pitrez PM. COMPARISON OF TWO INHALATIONAL TECHNIQUES FOR BRONCHODILATOR ADMINISTRATION IN CHILDREN AND ADOLESCENTS WITH ACUTE ASTHMA CRISIS: A META-ANALYSIS. Rev Paul Pediatr. 2018 Jul-Sep;36(3):364-371. doi: 10.1590/1984-0462/;2018;36;3;00002. Epub 2018 Jul 10.
- Background: PubMed 34012486Alharbi AS, Yousef AA, Alharbi SA, Al-Shamrani A, Alqwaiee MM, Almeziny M, Said YS, Alshehri SA, Alotaibi FN, Mosalli R, Alawam KA, Alsaadi MM. Application of aerosol therapy in respiratory diseases in children: A Saudi expert consensus. Ann Thorac Med. 2021 Apr-Jun;16(2):188-218. doi: 10.4103/atm.atm_74_21. Epub 2021 Apr 17.
- Background: PubMed 32940961Payares-Salamanca L, Contreras-Arrieta S, Florez-Garcia V, Barrios-Sanjuanelo A, Stand-Nino I, Rodriguez-Martinez CE. Metered-dose inhalers versus nebulization for the delivery of albuterol for acute exacerbations of wheezing or asthma in children: A systematic review with meta-analysis. Pediatr Pulmonol. 2020 Dec;55(12):3268-3278. doi: 10.1002/ppul.25077. Epub 2020 Sep 25.
- Background: PubMed 1325812Schell DN, Durham D, Murphree SS, Muntz KH, Shaul PW. Ontogeny of beta-adrenergic receptors in pulmonary arterial smooth muscle, bronchial smooth muscle, and alveolar lining cells in the rat. Am J Respir Cell Mol Biol. 1992 Sep;7(3):317-24. doi: 10.1165/ajrcmb/7.3.317.
- BackgroundDimino, K. Using A Metered Dose Inhaler (Mdi) With Spacer or Nebulizer for Managing Children Under 5 Years of Age with Exacerbation of Wheezing or Asthma. 2019; 11(2): 555815.10.19080/JOJNHC.2019.11.555815
- Individual participant dataSharing planned: Yes
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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.
Arooj Khan, MBBS principal investigator
Khyber Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metered Dose Inhaler With Spacer Device in people with Childhood Asthma With Acute Exacerbation, run by Khyber Teaching Hospital 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 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 11 Mar 2025. 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.
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?
compare mean pulmonary index score after treatment with salbutamol through nebulizers vs metered dose inhalers (time frame: 1 hour). 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 NCT06201156, which also lists 7 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 11 Mar 2025.