COPD ExacerbationNCT05507060
Evaluation of the Efficacy of Different Nebulization Techniques
A study testing Vibrating MESH nebulizer (Aerogen Ultra) and Jet nebulizers (Philips Respironics) in people with COPD Exacerbation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
COPD is the 3rd most common cause of death in the world, and the most common places of admission in our country with exacerbation of COPD are emergency services. β-2 agonists and/or short-acting anticholinergic drugs use is recommended in patients with COPD Salbutamol is known to cause significant improvement in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Vibrating MESH nebulizer (Aerogen Ultra) and Jet nebulizers (Philips Respironics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 25 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute exacerbation of COPD according to GOLD guidline,
- Being over 18 years old,
- Being able to read and to understand the spoken language and give consent.
Who cannot join
- Patients who need NIMW or intubation.
- Covid 19 or suspected patients
- cognitive disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdulhamid Han Research and Training Hospital
Istanbul
Erdem Cevik, MD, +905054515930, cevikerdem@yahoo.com
Melih Arınc, MD, +905385192804, meliharnc@gmail.com
About this study
Official title: Evaluation of the Efficacy of Different Nebulization Techniques in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Patients, Randomized, Single-blind, Clinical Trial
COPD is the 3rd most common cause of death in the world, and the most common places of admission in our country with exacerbation of COPD are emergency services. β-2 agonists and/or short-acting anticholinergic drugs use is recommended in patients with COPD Salbutamol is known to cause significant improvement in dyspnea, quality of life and FEV1 in patients with COPD. Various techniques are used to administer drugs, one of which is the nebulization technique and is frequently used in emergency departments. There are limited clinical studies comparing different nebulization techniques, and the aim of this study is to compare the efficacy of Vibrating MESH nebulizer versus Jet nebulizers in a COPD exacerbation patient.
Patients who applied to the Emergency Department of Sultan Abdulhamid Han Training and Research Hospital with the complaint of shortness of breath and were diagnosed with COPD exacerbation according to the Gold Guidelines and to be treated with nebulization will be included in the study. Patients who agreed to participate in the study will be divided into two groups and assigned sequentially according to the simple randomization schedule.
Medication will be applied to one group with Jet nebulizers (Philips Respironics) and to the other group with Vibrating MESH nebulizer (Aerogen Ultra). Vital signs, IPI, spirometric measurements (FEV 1, FVC, FEV1 / FVC, FEF 50, FEF 2575), and dyspnea VAS score will be recorded at admission and re-measured after 1hour of treatment . In addition, single dose nebulization time will be measured and patient satisfaction will be measured with a 5-linkert scale. Demographic data will be recorded. The measurements will be recorded in the patient file and the groups will be coded so that the researcher evaluating the data will be blinded to the groups. The patient could not be blinded because of the different shape of devices.
- Conditions
- COPD Exacerbation
- Being tested
- Vibrating MESH nebulizer (Aerogen Ultra), Jet nebulizers (Philips Respironics)
- Keywords
- COPD, nebulizers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating MESH nebulizer (Aerogen Ultra)Device
Medication will be applied with Vibrating MESH nebulizer
Jet nebulizers (Philips Respironics)Device
Medication will be applied with Jet nebulizers
| Study group | Role | What they receive |
|---|---|---|
| Vibrating MESH nebulizer | Active comparator | Medication will be applied with Vibrating MESH nebulizer Receives: Device: Vibrating MESH nebulizer (Aerogen Ultra) |
| Jet nebulizers | Active comparator | Medication will be applied with Jet nebulizers Receives: Device: Jet nebulizers (Philips Respironics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of spirometric measurement
Change of FEV 1%, FVC %, FEV1 / FVC %, FEF 50 %, FEF 2575 %
Measured: Change from pretreatment spirometric measurements at first hour.
Change of Integrated pulmonary index( IPI)
IPI will measured by Capnostream™ 35 Portable Respiratory Monitor. The device can give single digit, 1-10. 10 is normal and 1-2 is need immediately intervention
Measured: Change from pretreatment IPI at first hour.
VAS score change of dyspnea
0 is no dyspnea and 10 is the biggest dyspnea attacks
Measured: Change from pretreatment VAS score at first hour.
Secondary outcomes (2)
nebulization time
time from start to end of nebulization treatment will measured in minutes
Measured: Measured with each nebulization treatment at first hour
patient satisfaction
Satisfaction of nebulization treatment ( 5 Lincert scale)
Measured: Measured after each nebulization application at first hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Aug 2022
- Primary completion15 Sep 2022 (estimated)
- Study completion25 Sep 2022 (estimated)
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 COPD 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
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdem Cevik, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507060
- Sponsor's protocol ID
- Ecevik1
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol will be shared but Our clinical datas' are not available for sharig considering ethical problems.
Publications
Ashraf S, McPeck M, Cuccia AD, Smaldone GC. Comparison of Vibrating Mesh, Jet, and Breath-Enhanced Nebulizers During Mechanical Ventilation. Respir Care. 2020 Oct;65(10):1419-1426. doi: 10.4187/respcare.07639. Epub 2020 Jul 21.
PubMed 32694180Dogan NO, Varol Y, Kokturk N, Aksay E, Alpaydin AO, Corbacioglu SK, Aksel G, Baha A, Akoglu H, Karahan S, Sen E, Ergan B, Bayram B, Yilmaz S, Gurgun A, Polatli M. 2021 Guideline for the Management of COPD Exacerbations: Emergency Medicine Association of Turkey (EMAT) / Turkish Thoracic Society (TTS) Clinical Practice Guideline Task Force. Turk J Emerg Med. 2021 Oct 29;21(4):137-176. doi: 10.4103/2452-2473.329630. eCollection 2021 Oct-Dec.
PubMed 34849428Dailey PA, Shockley CM. Review of aerosol delivery in the emergency department. Ann Transl Med. 2021 Apr;9(7):591. doi: 10.21037/atm-20-4724.
PubMed 33987289Gerde P, Nowenwik M, Sjoberg CO, Selg E. Adapting the Aerogen Mesh Nebulizer for Dried Aerosol Exposures Using the PreciseInhale Platform. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):116-126. doi: 10.1089/jamp.2019.1554. Epub 2019 Oct 15.
PubMed 31613690Sweeney L, McCloskey AP, Higgins G, Ramsey JM, Cryan SA, MacLoughlin R. Effective nebulization of interferon-gamma using a novel vibrating mesh. Respir Res. 2019 Apr 3;20(1):66. doi: 10.1186/s12931-019-1030-1.
PubMed 30943978Kocak AO, Cakir Z, Akbas I, Gur STA, Kose MZ, Can NO, Sengun E, Gemis OF. Comparison of two scores of short term serious outcome in COPD patients. Am J Emerg Med. 2020 Jun;38(6):1086-1091. doi: 10.1016/j.ajem.2019.158376. Epub 2019 Jul 27.
PubMed 31378412Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.
PubMed 30545350
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Different Nebulization Techniques in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Patients, Randomized, Single-blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT05507060
- Acronym / sponsor ID
- Ecevik1
- Conditions
- COPD Exacerbation
- Keywords
- COPD, nebulizers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 25 Sep 2022 (estimated)
- First posted
- 18 Aug 2022 (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.
COPD is the 3rd most common cause of death in the world, and the most common places of admission in our country with exacerbation of COPD are emergency services. β-2 agonists and/or short-acting anticholinergic drugs use is recommended in patients with COPD Salbutamol is known to cause significant improvement in dyspnea, quality of life and FEV1 in patients with COPD. Various techniques are used to administer drugs, one of which is the nebulization technique and is frequently used in emergency departments. There are limited clinical studies comparing different nebulization techniques, and the aim of this study is to compare the efficacy of Vibrating MESH nebulizer versus Jet nebulizers in a COPD exacerbation patient.
Patients who applied to the Emergency Department of Sultan Abdulhamid Han Training and Research Hospital with the complaint of shortness of breath and were diagnosed with COPD exacerbation according to the Gold Guidelines and to be treated with nebulization will be included in the study. Patients who agreed to participate in the study will be divided into two groups and assigned sequentially according to the simple randomization schedule.
Medication will be applied to one group with Jet nebulizers (Philips Respironics) and to the other group with Vibrating MESH nebulizer (Aerogen Ultra). Vital signs, IPI, spirometric measurements (FEV 1, FVC, FEV1 / FVC, FEF 50, FEF 2575), and dyspnea VAS score will be recorded at admission and re-measured after 1hour of treatment . In addition, single dose nebulization time will be measured and patient satisfaction will be measured with a 5-linkert scale. Demographic data will be recorded. The measurements will be recorded in the patient file and the groups will be coded so that the researcher evaluating the data will be blinded to the groups. The patient could not be blinded because of the different shape of devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrating MESH nebulizer | Active comparator | Device: Vibrating MESH nebulizer (Aerogen Ultra)Medication will be applied with Vibrating MESH nebulizer |
| Jet nebulizers | Active comparator | Device: Jet nebulizers (Philips Respironics)Medication will be applied with Jet nebulizers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute exacerbation of COPD according to GOLD guidline,
- Being over 18 years old,
- Being able to read and to understand the spoken language and give consent.
Key exclusion criteria (3 listed)
- Patients who need NIMW or intubation.
- Covid 19 or suspected patients
- cognitive disorders
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 |
|---|---|---|
| Vibrating MESH nebulizer (Aerogen Ultra)Medication will be applied with Vibrating MESH nebulizer | Device | Vibrating MESH nebulizer |
| Jet nebulizers (Philips Respironics)Medication will be applied with Jet nebulizers | Device | Jet nebulizers |
Primary outcome
change of spirometric measurement
Time frame: Change from pretreatment spirometric measurements at first hour.
Change of FEV 1%, FVC %, FEV1 / FVC %, FEF 50 %, FEF 2575 %
Change of Integrated pulmonary index( IPI)
Time frame: Change from pretreatment IPI at first hour.
IPI will measured by Capnostream™ 35 Portable Respiratory Monitor. The device can give single digit, 1-10. 10 is normal and 1-2 is need immediately intervention
VAS score change of dyspnea
Time frame: Change from pretreatment VAS score at first hour.
0 is no dyspnea and 10 is the biggest dyspnea attacks
2 secondary outcomes
nebulization time
Time frame: Measured with each nebulization treatment at first hour
patient satisfaction
Time frame: Measured after each nebulization application at first hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 32694180Ashraf S, McPeck M, Cuccia AD, Smaldone GC. Comparison of Vibrating Mesh, Jet, and Breath-Enhanced Nebulizers During Mechanical Ventilation. Respir Care. 2020 Oct;65(10):1419-1426. doi: 10.4187/respcare.07639. Epub 2020 Jul 21.
- Background: PubMed 34849428Dogan NO, Varol Y, Kokturk N, Aksay E, Alpaydin AO, Corbacioglu SK, Aksel G, Baha A, Akoglu H, Karahan S, Sen E, Ergan B, Bayram B, Yilmaz S, Gurgun A, Polatli M. 2021 Guideline for the Management of COPD Exacerbations: Emergency Medicine Association of Turkey (EMAT) / Turkish Thoracic Society (TTS) Clinical Practice Guideline Task Force. Turk J Emerg Med. 2021 Oct 29;21(4):137-176. doi: 10.4103/2452-2473.329630. eCollection 2021 Oct-Dec.
- Background: PubMed 33987289Dailey PA, Shockley CM. Review of aerosol delivery in the emergency department. Ann Transl Med. 2021 Apr;9(7):591. doi: 10.21037/atm-20-4724.
- Background: PubMed 31613690Gerde P, Nowenwik M, Sjoberg CO, Selg E. Adapting the Aerogen Mesh Nebulizer for Dried Aerosol Exposures Using the PreciseInhale Platform. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):116-126. doi: 10.1089/jamp.2019.1554. Epub 2019 Oct 15.
- Background: PubMed 30943978Sweeney L, McCloskey AP, Higgins G, Ramsey JM, Cryan SA, MacLoughlin R. Effective nebulization of interferon-gamma using a novel vibrating mesh. Respir Res. 2019 Apr 3;20(1):66. doi: 10.1186/s12931-019-1030-1.
- Background: PubMed 31378412Kocak AO, Cakir Z, Akbas I, Gur STA, Kose MZ, Can NO, Sengun E, Gemis OF. Comparison of two scores of short term serious outcome in COPD patients. Am J Emerg Med. 2020 Jun;38(6):1086-1091. doi: 10.1016/j.ajem.2019.158376. Epub 2019 Jul 27.
- Results publication: PubMed 30545350Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.
- KOAH alevlenme ile acil servis'e başvuran hastalarda, spirometrik ölçümler, ciddiyet skorları ve laboratuvar parametrelerinin prognozu öngörmedeki değeriLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study protocol will be shared but Our clinical datas' are not available for sharig considering ethical problems.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating MESH nebulizer (Aerogen Ultra) and Jet nebulizers (Philips Respironics) in people with COPD Exacerbation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 3 inclusion and 3 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 18 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erdem Cevik, MD (+905054515930, cevikerdem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of spirometric measurement (time frame: Change from pretreatment spirometric measurements at first hour.). The study lists 3 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 NCT05507060, 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 18 Aug 2022.