AsthmaNCT06211998
Comparison of Mesh Nebulizer and Compressor Nebulizer With Pulmonary Function Test in Pediatric Asthma Attacks
A study testing Group 1 and Group 2 in people with Asthma and Asthma in Children, run by Berker Okay at 1 site in Turkey (Türkiye).
Trial summary
Asthma is a worldwide health problem and is one of the most common chronic diseases of childhood in most countries. Symptoms begin before the age of 5 years in 80% of children with asthma, but the diagnosis is not always easy. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Aug 2023
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asthma attack patients who need inhaler therapy (salbutamol)
- Patients aged 7-15 years and whose families gave consent for the study
Who cannot join
- Patients with neuromotor impairment
- Patients with underlying chronic disease (neurological disease such as epilepsy or congenital heart disease)
- Patients with obesity or malnutrition (to equalize drug dose efficacy)
- Patients with those receiving adrenaline, budesonide or ipratropium bromide therapy
- Patients who have used a long-acting bronchodilator in the last 12 hours or a short-acting bronchodilator in the last 2 hours
- Patients with fever above 37.5°C
Show all 11Show fewer
- Patients with a saturation value below 92% at the time of admission
- Patients with severe asthma attack
- Patients with respiratory failure
- Patients who had problems in performing the test (such as mental retardation, patient incompatibility)
- Patients with diseases involving the chest muscles and those with chronic lung diseases (such as cystic fibrosis, bronchiectasis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
UHS Haseki Training and Research Hospital
Istanbul, Sultangazi, 34304
About this study
Official title: Comparison of Mesh Nebulizer and Compressor Nebulizer on Pulmonary Function Test in Children Presenting With Asthma Attack: A Double-Blind Randomized Comparative Clinical Trial
Asthma is a worldwide health problem and is one of the most common chronic diseases of childhood in most countries. Symptoms begin before the age of 5 years in 80% of children with asthma, but the diagnosis is not always easy. The National Asthma Education and Prevention Program (NAEPP) expert panel recommends spirometry testing for children over 5 years of age. Spirometry measurements include forced vital capacity (FVC) and the forced expiratory volume in first second (FEV1). Airflow obstruction is defined as FEV1 reduced to less than 80 percent predicted and an FEV1/FVC ratio of less than 0.85 (85 percent). Reference values are based on age, height, sex, and race. Forced expiratory flow between 25 and 75 percent of vital capacity (FEF25-75) less than 65 percent correlates with reversible airflow obstruction in children with normal FEV1 and may be a useful measure in this subgroup.
In the spirometry test, FEV1, FVC, FEF 25-75% values are valuable for the follow-up of asthma. While the FEV1/FVC ratio is above 80% in healthy children, it may decrease below 75% in diseases such as asthma. Likewise, FEV1 and FEF can be found to be low in 50-75% of asthma patients. In addition, these values can be used to determine the effectiveness of the inhaler given with the nebulizer given during the attack. Spirometry should be performed before and after administration of a bronchodilator to assess for reversibility (bronchodilator response [BDR]) even in children with a normal baseline FEV1 because many of these children will still have a BDR (both within the normal range and sometimes also supranormal) after treatment. Significant reversibility is indicated by an increase in FEV1 of ≥12 percent from baseline after administration of a short-acting bronchodilator. This definition for BDR positivity was established primarily in adults. An increase in FEV1 of ≥8 percent may be a better definition for BDR in children.
Read more
Inhaled short-acting beta-2 agonists, particularly albuterol (salbutamol), are the standard emergent treatment for acute asthma exacerbations in all patients based upon adult data. It is recommended to be given every 20 minutes in case of need for repeated doses in mild and moderate asthma attacks. Different types of nebulizers can be used for inhaler therapy; they can convert drugs into vapor form with sound waves, compressed air or by using electrical energy. While compressor nebulizers convert the liquid drug into aerosol form with compressed air, mesh nebulizers convert the drug into aerosol form with the vibrations they create with the help of electrical energy. Mesh nebulizers are more effective than other types of nebulizers, and the amount left in the chamber is less than other models, and it can decompose the drug into smaller particles and reach the more extreme branches of the lung.
In our study, the investigators aimed to determine which nebulizer type is more effective by comparing the effects of mesh nebulizer and compressor nebulizer on spirometry test in children presenting with asthma attack. Thus, the investigators planned to find the most comfortable and effective method for patients by determining the appropriate nebulization technique for patients.
- Conditions
- Asthma, Asthma in Children
- Being tested
- Group 1, Group 2
- Keywords
- Asthma, Child, Compressor Nebulizer, Mesh Nebulizer, Pulmonary function test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Device
Salbutamol inhaler, Omron® CompAIR Pro NE-C900 Compressor Nebulizer (Omron Healthcare Co., Ltd., Kyoto, Japan) was used in Group 1
Group 2Device
Salbutamol inhaler, Mesh nebulizer (Aerogen Solo®, Aerogen Ltd, Galway, Ireland) was used in Group 2
| Study group | Role | What they receive |
|---|---|---|
| Group receiving inhaled treatment with compressor nebulizer | Active comparator | Salbutamol inhaler, Omron® CompAIR Pro NE-C900 Compressor Nebulizer (Omron Healthcare Co., Ltd., Kyoto, Japan) was used in Group 1 Receives: Device: Group 1 |
| Group receiving inhaled treatment with mesh nebulizer | Active comparator | Salbutamol inhaler, Mesh nebulizer (Aerogen Solo®, Aerogen Ltd, Galway, Ireland) was used in Group 2 Receives: Device: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesh nebulizer improves pulmonary function test results more effectively in children
Pulmonary function test results in children using mesh nebulizers may be improving more effectively.
To compare mesh and compressor nebulizers, we planned to compare FEV1, FVC, FEV1/FVC, FEF 25-75 and PEF in pulmonary function testing.
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 posted18 Jan 2024
- Study start1 Aug 2022
- Primary completion15 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berker Okay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berker Okay, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211998
- Sponsor's protocol ID
- 140-2022
- Status last verified
- Jan 2024
- First submitted
- 25 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunne RB, Shortt S. Comparison of bronchodilator administration with vibrating mesh nebulizer and standard jet nebulizer in the emergency department. Am J Emerg Med. 2018 Apr;36(4):641-646. doi: 10.1016/j.ajem.2017.10.067. Epub 2017 Oct 31.
PubMed 29167030Pitance L, Vecellio L, Leal T, Reychler G, Reychler H, Liistro G. Delivery efficacy of a vibrating mesh nebulizer and a jet nebulizer under different configurations. J Aerosol Med Pulm Drug Deliv. 2010 Dec;23(6):389-96. doi: 10.1089/jamp.2010.0816. Epub 2010 Oct 19.
PubMed 20958144Yuksel H, Yasar A, Acikel A, Topcu I, Yilmaz O. Two different methods of lidocaine inhalation before diagnostic flexible bronchoscopy: effects on post-bronchoscopy respiratory symptoms. Turk J Med Sci. 2021 Aug 30;51(4):2101-2106. doi: 10.3906/sag-2012-130.
PubMed 34013705Okay B, Hatipoglu HU, Okay ZU, Sahin K, Yasar A. Comparing mesh and compressor nebulizers in pulmonary function test in pediatric asthma attacks: A double-blind randomized comparative clinical trial. Respir Med. 2025 Mar;238:107966. doi: 10.1016/j.rmed.2025.107966. Epub 2025 Jan 28.
PubMed 39884589
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mesh Nebulizer and Compressor Nebulizer on Pulmonary Function Test in Children Presenting With Asthma Attack: A Double-Blind Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06211998
- Acronym / sponsor ID
- 140-2022
- Conditions
- Asthma, Asthma in Children
- Keywords
- Asthma, Child, Compressor Nebulizer, Mesh Nebulizer, Pulmonary function test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Berker OkayUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 18 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.
Asthma is a worldwide health problem and is one of the most common chronic diseases of childhood in most countries. Symptoms begin before the age of 5 years in 80% of children with asthma, but the diagnosis is not always easy. The National Asthma Education and Prevention Program (NAEPP) expert panel recommends spirometry testing for children over 5 years of age. Spirometry measurements include forced vital capacity (FVC) and the forced expiratory volume in first second (FEV1). Airflow obstruction is defined as FEV1 reduced to less than 80 percent predicted and an FEV1/FVC ratio of less than 0.85 (85 percent). Reference values are based on age, height, sex, and race. Forced expiratory flow between 25 and 75 percent of vital capacity (FEF25-75) less than 65 percent correlates with reversible airflow obstruction in children with normal FEV1 and may be a useful measure in this subgroup.
In the spirometry test, FEV1, FVC, FEF 25-75% values are valuable for the follow-up of asthma. While the FEV1/FVC ratio is above 80% in healthy children, it may decrease below 75% in diseases such as asthma. Likewise, FEV1 and FEF can be found to be low in 50-75% of asthma patients. In addition, these values can be used to determine the effectiveness of the inhaler given with the nebulizer given during the attack. Spirometry should be performed before and after administration of a bronchodilator to assess for reversibility (bronchodilator response [BDR]) even in children with a normal baseline FEV1 because many of these children will still have a BDR (both within the normal range and sometimes also supranormal) after treatment. Significant reversibility is indicated by an increase in FEV1 of ≥12 percent from baseline after administration of a short-acting bronchodilator. This definition for BDR positivity was established primarily in adults. An increase in FEV1 of ≥8 percent may be a better definition for BDR in children.
Inhaled short-acting beta-2 agonists, particularly albuterol (salbutamol), are the standard emergent treatment for acute asthma exacerbations in all patients based upon adult data. It is recommended to be given every 20 minutes in case of need for repeated doses in mild and moderate asthma attacks. Different types of nebulizers can be used for inhaler therapy; they can convert drugs into vapor form with sound waves, compressed air or by using electrical energy. While compressor nebulizers convert the liquid drug into aerosol form with compressed air, mesh nebulizers convert the drug into aerosol form with the vibrations they create with the help of electrical energy. Mesh nebulizers are more effective than other types of nebulizers, and the amount left in the chamber is less than other models, and it can decompose the drug into smaller particles and reach the more extreme branches of the lung.
In our study, the investigators aimed to determine which nebulizer type is more effective by comparing the effects of mesh nebulizer and compressor nebulizer on spirometry test in children presenting with asthma attack. Thus, the investigators planned to find the most comfortable and effective method for patients by determining the appropriate nebulization technique for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving inhaled treatment with compressor nebulizer | Active comparator | Device: Group 1Salbutamol inhaler, Omron® CompAIR Pro NE-C900 Compressor Nebulizer (Omron Healthcare Co., Ltd., Kyoto, Japan) was used in Group 1 |
| Group receiving inhaled treatment with mesh nebulizer | Active comparator | Device: Group 2Salbutamol inhaler, Mesh nebulizer (Aerogen Solo®, Aerogen Ltd, Galway, Ireland) was used in Group 2 |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Asthma attack patients who need inhaler therapy (salbutamol)
- Patients aged 7-15 years and whose families gave consent for the study
Key exclusion criteria (11 listed)
- Patients with neuromotor impairment
- Patients with underlying chronic disease (neurological disease such as epilepsy or congenital heart disease)
- Patients with obesity or malnutrition (to equalize drug dose efficacy)
- Patients with those receiving adrenaline, budesonide or ipratropium bromide therapy
- Patients who have used a long-acting bronchodilator in the last 12 hours or a short-acting bronchodilator in the last 2 hours
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 |
|---|---|---|
| Group 1Salbutamol inhaler, Omron® CompAIR Pro NE-C900 Compressor Nebulizer (Omron Healthcare Co., Ltd., Kyoto, Japan) was used in Group 1 | Device | Group receiving inhaled treatment with compressor nebulizer |
| Group 2Salbutamol inhaler, Mesh nebulizer (Aerogen Solo®, Aerogen Ltd, Galway, Ireland) was used in Group 2 | Device | Group receiving inhaled treatment with mesh nebulizer |
Primary outcome
Mesh nebulizer improves pulmonary function test results more effectively in children
Time frame: 1 hour
Pulmonary function test results in children using mesh nebulizers may be improving more effectively. To compare mesh and compressor nebulizers, we planned to compare FEV1, FVC, FEV1/FVC, FEF 25-75 and PEF in pulmonary function testing.
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 18 Jan 2024.
- Background: PubMed 29167030Dunne RB, Shortt S. Comparison of bronchodilator administration with vibrating mesh nebulizer and standard jet nebulizer in the emergency department. Am J Emerg Med. 2018 Apr;36(4):641-646. doi: 10.1016/j.ajem.2017.10.067. Epub 2017 Oct 31.
- Background: PubMed 20958144Pitance L, Vecellio L, Leal T, Reychler G, Reychler H, Liistro G. Delivery efficacy of a vibrating mesh nebulizer and a jet nebulizer under different configurations. J Aerosol Med Pulm Drug Deliv. 2010 Dec;23(6):389-96. doi: 10.1089/jamp.2010.0816. Epub 2010 Oct 19.
- Background: PubMed 34013705Yuksel H, Yasar A, Acikel A, Topcu I, Yilmaz O. Two different methods of lidocaine inhalation before diagnostic flexible bronchoscopy: effects on post-bronchoscopy respiratory symptoms. Turk J Med Sci. 2021 Aug 30;51(4):2101-2106. doi: 10.3906/sag-2012-130.
- Derived from this study: PubMed 39884589Okay B, Hatipoglu HU, Okay ZU, Sahin K, Yasar A. Comparing mesh and compressor nebulizers in pulmonary function test in pediatric asthma attacks: A double-blind randomized comparative clinical trial. Respir Med. 2025 Mar;238:107966. doi: 10.1016/j.rmed.2025.107966. Epub 2025 Jan 28.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 and Group 2 in people with Asthma and Asthma in Children, run by Berker Okay at 1 site in Turkey (Türkiye).
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 11 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 18 Jan 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 Turkey (Türkiye). 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?
Mesh nebulizer improves pulmonary function test results more effectively in children (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 NCT06211998, which also lists 4 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 18 Jan 2024.