Asthma ExacerbationPhase 4NCT06918418
A Comparative Study of Adding Ipratropium to Salbutamol for the Treatment of Asthma Attack in Children
A Phase 4 study testing Salbutamol (Ventolin®) and salbutamol + ipratropium bromide nebules in people with Asthma Exacerbation and Children, run by Children's Hospital and Institute of Child Health, Multan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children. The main question this study aimed to answer was: Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone? Researchers compared… Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Asthma Exacerbation, Children
- What is being tested?
- Salbutamol (Ventolin®) and salbutamol + ipratropium bromide nebules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 15 Jul 2024
- 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
- Children with acute asthma exacerbation (presenting with wheeze, labored breathing with ronchi audible on auscultation)
- Within 12 hours of symptom onset
Who cannot join
- Children with known pulmonary and/or cardiac congenital malformations
- Bronchopulmonary dysplasia
- Cystic fibrosis
- Post infectious bronchiolitis obliterans
- Altered mental status on presentation with imminent respiratory failure (pulmonary asthma score ≥ 10, cases needing PICU care)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children's Hospital and Institute of Child Health
Multan, Punjab Province, 60000
About this study
Official title: Comparison of Salbutamol Alone and Salbutamol in Combination With Ipratropium Bromide in Treatment of Acute Asthma in Children
The goal of this clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children.
The main question this study aimed to answer was:
Read more
Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone?
Researchers compared salbutamol alone to a combination of salbutamol and ipratropium in children with acute asthma.
Participants:
(i) Received either salbutamol alone or salbutamol with ipratropium via nebulization for 4 hours
(ii) Had their asthma symptoms assessed before and after treatment
(iii) Were discharged with continued treatment and counseling if stable
This study was conducted in the Department of Pediatric Medicine, Children's Hospital Multan, over six months. A total of 60 children with acute asthma were included.
Read the detailed description
Children presenting with asthma exacerbation were assessed for eligibility. Eligible participants had their baseline characteristics recorded including age, gender, history of parental asthma, duration of asthma diagnosis, use of asthma controllers (inhaled corticosteroids, Long Acting Beta Agonist (LABA), Montelukast) \& baseline pulmonary asthma score. Through lottery method using sequentially numbered sealed opaque envelopes children were assigned to group A and group B treatments. At the end of 4-hours of therapy, pulmonary asthma score was re-assessed by pediatrician not aware of treatment assigned. Once stabilized, the children were discharged on regular nebulization therapy with controller medication after proper counseling.
- Conditions
- Asthma Exacerbation, Children
- Being tested
- Salbutamol (Ventolin®), salbutamol + ipratropium bromide nebules
- Keywords
- Asthma, Salbutamol, Ipratropium Bromide, Pulmonary Asthma Score
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol (Ventolin®)Drug
Also called Albuterol
Children were given 0.5% salbutamol aerosol solution (0.15 mg/kg weight, up to a maximum of 5 mg) in 5mL of normal saline solution for 7 min every 20 min for 2 h, and then every 30 min for two more hours. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask.
salbutamol + ipratropium bromide nebulesDrug
Also called Albuterol, Atrovent
In addition to Salbutamol nebulization, children received ipratropium bromide nebulization. Ipratropium bromide solution (250 mcg in children <20 kg weight or 500 mcg in children >=20 kg) every 20 min for the first 2 hours then every 30 min for 2 hours more will be given in between the salbutamol nebulization. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask.
| Study group | Role | What they receive |
|---|---|---|
| Combined Nebulization | Experimental | Combined Salbutamol and Ipratropium Bromide Receives: Drug: salbutamol + ipratropium bromide nebules |
| Single Nebulization | Active comparator | Salbutamol Nebulization alone Receives: Drug: Salbutamol (Ventolin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Asthma Score (PAS)
Asthma severity was assessed using Pulmonary Asthma score. It uses respiratory rate, wheezing, inspiration to expiration ratio (I:E) and use of accessory muscles graded 0 - 3 with total score of 12.
Measured: On presentation and four hours after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Umair, Children's Hospital and Institute of Child Health, Multan
- Investigators
- Dr. Muhammad Aslam Sheikh, FCPS, Study chair, Children's Hospital and Institute of Child Health, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918418
- Sponsor's protocol ID
- U1111-1321-1030
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the study involves children, there are strict ethical guidelines regarding data privacy and protection of minors' health information. Sharing detailed IPD may risk re-identification.
Publications
Iramain R, Lopez-Herce J, Coronel J, Spitters C, Guggiari J, Bogado N. Inhaled salbutamol plus ipratropium in moderate and severe asthma crises in children. J Asthma. 2011 Apr;48(3):298-303. doi: 10.3109/02770903.2011.555037. Epub 2011 Feb 21.
PubMed 21332430Memon BN, Parkash A, Ahmed Khan KM, Gowa MA, Bai C. Response to nebulized salbutamol versus combination with ipratropium bromide in children with acute severe asthma. J Pak Med Assoc. 2016 Mar;66(3):243-6.
PubMed 26968269
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salbutamol Alone and Salbutamol in Combination With Ipratropium Bromide in Treatment of Acute Asthma in Children
- ClinicalTrials.gov ID
- NCT06918418
- Acronym / sponsor ID
- U1111-1321-1030
- Conditions
- Asthma Exacerbation, Children
- Keywords
- Asthma, Salbutamol, Ipratropium Bromide, Pulmonary Asthma Score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 9 Apr 2025 (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 clinical trial was to determine if adding ipratropium bromide to salbutamol improves asthma treatment in children.
The main question this study aimed to answer was:
Does combining ipratropium with salbutamol improve asthma symptoms more effectively than salbutamol alone?
Researchers compared salbutamol alone to a combination of salbutamol and ipratropium in children with acute asthma.
Participants:
(i) Received either salbutamol alone or salbutamol with ipratropium via nebulization for 4 hours
(ii) Had their asthma symptoms assessed before and after treatment
(iii) Were discharged with continued treatment and counseling if stable
This study was conducted in the Department of Pediatric Medicine, Children's Hospital Multan, over six months. A total of 60 children with acute asthma were included.
Detailed description
Children presenting with asthma exacerbation were assessed for eligibility. Eligible participants had their baseline characteristics recorded including age, gender, history of parental asthma, duration of asthma diagnosis, use of asthma controllers (inhaled corticosteroids, Long Acting Beta Agonist (LABA), Montelukast) \& baseline pulmonary asthma score. Through lottery method using sequentially numbered sealed opaque envelopes children were assigned to group A and group B treatments. At the end of 4-hours of therapy, pulmonary asthma score was re-assessed by pediatrician not aware of treatment assigned. Once stabilized, the children were discharged on regular nebulization therapy with controller medication after proper counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Nebulization | Experimental | Drug: salbutamol + ipratropium bromide nebulesCombined Salbutamol and Ipratropium Bromide |
| Single Nebulization | Active comparator | Drug: Salbutamol (Ventolin®)Salbutamol Nebulization alone |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with acute asthma exacerbation (presenting with wheeze, labored breathing with ronchi audible on auscultation)
- Within 12 hours of symptom onset
Key exclusion criteria (5 listed)
- Children with known pulmonary and/or cardiac congenital malformations
- Bronchopulmonary dysplasia
- Cystic fibrosis
- Post infectious bronchiolitis obliterans
- Altered mental status on presentation with imminent respiratory failure (pulmonary asthma score ≥ 10, cases needing PICU care)
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 |
|---|---|---|
| Salbutamol (Ventolin®)Also: AlbuterolChildren were given 0.5% salbutamol aerosol solution (0.15 mg/kg weight, up to a maximum of 5 mg) in 5mL of normal saline solution for 7 min every 20 min for 2 h, and then every 30 min for two more hours. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask. | Drug | Single Nebulization |
| salbutamol + ipratropium bromide nebulesAlso: Albuterol, AtroventIn addition to Salbutamol nebulization, children received ipratropium bromide nebulization. Ipratropium bromide solution (250 mcg in children <20 kg weight or 500 mcg in children >=20 kg) every 20 min for the first 2 hours then every 30 min for 2 hours more will be given in between the salbutamol nebulization. Aerosol were generated by nebulizer powered by compressed-air (5 L/min) with Y-connection with oxygen (3 L/min) and delivered via a face mask. | Drug | Combined Nebulization |
Primary outcome
Pulmonary Asthma Score (PAS)
Time frame: On presentation and four hours after treatment.
Asthma severity was assessed using Pulmonary Asthma score. It uses respiratory rate, wheezing, inspiration to expiration ratio (I:E) and use of accessory muscles graded 0 - 3 with total score of 12.
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 9 Apr 2025.
- Background: PubMed 21332430Iramain R, Lopez-Herce J, Coronel J, Spitters C, Guggiari J, Bogado N. Inhaled salbutamol plus ipratropium in moderate and severe asthma crises in children. J Asthma. 2011 Apr;48(3):298-303. doi: 10.3109/02770903.2011.555037. Epub 2011 Feb 21.
- Background: PubMed 26968269Memon BN, Parkash A, Ahmed Khan KM, Gowa MA, Bai C. Response to nebulized salbutamol versus combination with ipratropium bromide in children with acute severe asthma. J Pak Med Assoc. 2016 Mar;66(3):243-6.
- Individual participant dataSharing planned: No. Since the study involves children, there are strict ethical guidelines regarding data privacy and protection of minors' health information. Sharing detailed IPD may risk re-identification.
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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.
Dr. Muhammad Aslam Sheikh, FCPS study chair
Children's Hospital and Institute of Child Health, Multan
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 Salbutamol (Ventolin®) and salbutamol + ipratropium bromide nebules in people with Asthma Exacerbation and Children, run by Children's Hospital and Institute of Child Health, Multan 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 2 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 9 Apr 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.
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?
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?
Pulmonary Asthma Score (PAS) (time frame: On presentation and four hours after treatment.). 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 NCT06918418, which also lists 2 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 9 Apr 2025.