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Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06178068
Enrollment
39
Registered
2023-12-20
Start date
2024-01-01
Completion date
2025-01-01
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation Acute

Brief 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. 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.

Interventions

DEVICEComparison of bronchodilator effectiveness of nebulizer therapy devices

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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Group E COPD patients

Exclusion criteria

* Recent MI * Pulmonary embolism * Cerebral aneurysm * Active hemoptysis * Pneumothorax * Nausea, vomiting * 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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests5 daysMeasurement 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 tests5 daysSaturation %, measurement of change in partial oxygen and partial carbon dioxide levels in mm\_Hg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026