COPD Exacerbation AcuteNCT06178068
Comparison of Bronchodilator Treatment Practices in Group E COPD Patients
A study testing Comparison of bronchodilator effectiveness of nebulizer therapy devices in people with COPD Exacerbation Acute, run by Ataturk University.
Trial summary
COPD is a heterogeneous condition caused by airway (bronchitis/bronchiolitis) or alveolar (emphysema) abnormality, changes with chronic respiratory changes (dyspnea, dyspnoea, phlegm). It is characterized by persistent and frequently progressive airway obstruction. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD Exacerbation Acute
- What is being tested?
- Comparison of bronchodilator effectiveness of nebulizer therapy devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2025
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group E COPD patients
Who cannot join
- Recent MI
- Pulmonary embolism
- Cerebral aneurysm
- Active hemoptysis
- Pneumothorax
- Nausea, vomiting
Show all 11Show fewer
- Recent thorax, abdominal, and eye surgery were identified in the patients before the pulmonary function test and were not included in the study.
- Mental retardation
- Pneumonia with acute exacerbation of COPD
- Patients with pulmonary edema due to congestive heart failure
- Patients with interstitial lung disease along with COPD
About this study
COPD is a heterogeneous condition caused by airway (bronchitis/bronchiolitis) or alveolar (emphysema) abnormality, changes with chronic respiratory changes (dyspnea, dyspnoea, phlegm). It is characterized by persistent and frequently progressive airway obstruction. In COPD, which progresses with high mortality, non-pharmacological treatments are applied, as well as pharmacological treatments. They have an essential place in slowing down the progressive course of this treatment. However, despite the treatment administered to COPD patients, outdoor weather conditions, improper use of inhaler treatments, or comorbidities may cause acute exacerbation of COPD.
Dry air nebulizer devices use dry air from the central system in hospitals. This system, which converts bronchodilator drugs into nebulizers by creating high currents, works like classical nebulizers without an electrical system and can have a higher flow rate than jet nebulizer devices. This procedure, which can be applied to COPD patients without giving high-flow oxygen, prevents carbon dioxide retention. There is no study in the literature comparing the bronchodilator effectiveness of dry air, classical nebulizer, and jet nebulizer, and the investigators aimed to compare the efficacy of these three treatment modalities in our study.
- Conditions
- COPD Exacerbation Acute
- Being tested
- Comparison of bronchodilator effectiveness of nebulizer therapy devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of bronchodilator effectiveness of nebulizer therapy devicesDevice
The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. In Group 2 and 3 patients, the flow system could be adjusted manually. To be consistent with Group 1 patients, bronchodilator treatment was administered at a 6 lt/min flow rate.
| Study group | Role | What they receive |
|---|---|---|
| Group 1; jet nebulizer group | Active comparator | The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. Receives: Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices |
| Group 2; dry air nebulizer group | Active comparator | In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. Receives: Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices |
| Group 3; Classic nebülizer group | Active comparator | For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. Receives: Device: Comparison of bronchodilator effectiveness of nebulizer therapy devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests
Measurement of % change in FVC, FEV1, RV, TLC level
Measured: 5 days
Evaluation of the change in arterial blood gas parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests
Saturation %, measurement of change in partial oxygen and partial carbon dioxide levels in mm_Hg
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bugra Kerget, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178068
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/122
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bronchodilator Treatment Practices in Group E COPD Patients
- ClinicalTrials.gov ID
- NCT06178068
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/122
- Conditions
- COPD Exacerbation Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Dec 2023 (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 a heterogeneous condition caused by airway (bronchitis/bronchiolitis) or alveolar (emphysema) abnormality, changes with chronic respiratory changes (dyspnea, dyspnoea, phlegm). It is characterized by persistent and frequently progressive airway obstruction. In COPD, which progresses with high mortality, non-pharmacological treatments are applied, as well as pharmacological treatments. They have an essential place in slowing down the progressive course of this treatment. However, despite the treatment administered to COPD patients, outdoor weather conditions, improper use of inhaler treatments, or comorbidities may cause acute exacerbation of COPD.
Dry air nebulizer devices use dry air from the central system in hospitals. This system, which converts bronchodilator drugs into nebulizers by creating high currents, works like classical nebulizers without an electrical system and can have a higher flow rate than jet nebulizer devices. This procedure, which can be applied to COPD patients without giving high-flow oxygen, prevents carbon dioxide retention. There is no study in the literature comparing the bronchodilator effectiveness of dry air, classical nebulizer, and jet nebulizer, and the investigators aimed to compare the efficacy of these three treatment modalities in our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1; jet nebulizer group | Active comparator | Device: Comparison of bronchodilator effectiveness of nebulizer therapy devicesThe Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. |
| Group 2; dry air nebulizer group | Active comparator | Device: Comparison of bronchodilator effectiveness of nebulizer therapy devicesIn Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. |
| Group 3; Classic nebülizer group | Active comparator | Device: Comparison of bronchodilator effectiveness of nebulizer therapy devicesFor classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Group E COPD patients
Key exclusion criteria (11 listed)
- Recent MI
- Pulmonary embolism
- Cerebral aneurysm
- Active hemoptysis
- Pneumothorax
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 |
|---|---|---|
| Comparison of bronchodilator effectiveness of nebulizer therapy devicesThe Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min. In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer. For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used. In Group 2 and 3 patients, the flow system could be adjusted manually. To be consistent with Group 1 patients, bronchodilator treatment was administered at a 6 lt/min flow rate. | Device | Group 1; jet nebulizer group, Group 2; dry air nebulizer group, Group 3; Classic nebülizer group |
Primary outcome
Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests
Time frame: 5 days
Measurement of % change in FVC, FEV1, RV, TLC level
Evaluation of the change in arterial blood gas parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests
Time frame: 5 days
Saturation %, measurement of change in partial oxygen and partial carbon dioxide levels in mm_Hg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of bronchodilator effectiveness of nebulizer therapy devices in people with COPD Exacerbation Acute, run by Ataturk University.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2023.