PneumoniaNCT07586345
The Effectiveness of Different Nebulized Solutions on Airway Clearance Function in Patients With Pneumonia
A study testing Nebulization therapy in people with Pneumonia and Airway Clearance, run by Chen, Yao-Hsiang.
Trial summary
Pneumonia is a significant global and national health issue, particularly posing a notable threat to elderly population. Accumulation of sputum in pneumonia patients often results in impaired airway clearance, negatively impacting disease management and recovery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pneumonia, Airway Clearance
- What is being tested?
- Nebulization therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with pneumonia, defined by ICD-10 codes, including:
- J18: Pneumonia, unspecified organism J180: Bronchopneumonia, unspecified organism J181: Lobar pneumonia, unspecified organism J182: Hypostatic pneumonia, unspecified organism J188: Other pneumonia, unspecified organism J189: Pneumonia, unspecified organism
- Aged 18-100 years
- Clinical respiratory score > 3
- Patients unable to expectorate sputum spontaneously and requiring assisted suctioning
Who cannot join
- Diagnosis of influenza-associated pneumonia, defined by ICD-10 codes, including:
- J09X1: Influenza due to identified novel influenza A virus with pneumonia J1001: Influenza due to other identified influenza virus with the same identified influenza viral pneumonia J100: Influenza due to other identified influenza virus with pneumonia
- Diagnosis of COVID-19 infection, defined by ICD-10 code:
- U07.1: COVID-19, virus identified
- History of chronic obstructive pulmonary disease (COPD) (ICD-10 code: J44)
- History of lung cancer or metastatic cancer involving the lungs
Show all 10Show fewer
- Current use of bronchodilators
- Patients requiring oral suctioning only
- Oxygen therapy with a flow rate > 10 L/min
- Clinical respiratory score > 8 (Table 2)
About this study
Pneumonia is a significant global and national health issue, particularly posing a notable threat to elderly population. Accumulation of sputum in pneumonia patients often results in impaired airway clearance, negatively impacting disease management and recovery. Clinically, nebulization therapy is widely employed to facilitate sputum clearance; however, evidence regarding the comparative effectiveness of different nebulized solution concentrations remains limited and inconsistent. Therefore, this study aims to evaluate and compare the clinical effects of nebulized solutions with various osmotic concentrations (3% hypertonic saline, 0.9% normal saline, 0.45% hypotonic saline, and distilled water) on airway clearance in patients with pneumonia. A randomized, double-blind controlled trial design will be used, recruiting 80 patients with pneumonia from a regional teaching hospital in northern Taiwan. Participants will be randomly assigned into four groups, receiving nebulized therapy four times daily over a period of seven days. This study outcome including the length of hospital stay, venous blood gas analysis, routine sputum examination, and arterial oxygen content. The findings of this the study are anticipated to provide evidence-based recommendations for the clinical application of nebulized solutions with different concentrations, aiming to enhance airway clearance efficiency, improve clinical care outcomes for pneumonia patients, and serve as a practical reference for healthcare professionals.
- Conditions
- Pneumonia, Airway Clearance
- Being tested
- Nebulization therapy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization therapyOther
Comparison of different concentrations of saline solutions used for nebulization therapy
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Other: Nebulization therapy |
| Hypertonic group | Active comparator | Not described Receives: Other: Nebulization therapy |
| Isotonic group | Active comparator | Not described Receives: Other: Nebulization therapy |
| Hypotonic group | Active comparator | Not described Receives: Other: Nebulization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein blood gas
Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.
Measured: Measurements were performed before the intervention and at 7 days after the intervention.
Sputum routine examination
Assessment of sputum characteristics and routine laboratory findings.
Measured: Measurements were performed before the intervention and at 7 days after the intervention.
Arterial oxygen content (CaO₂)
Measurement of arterial oxygen content calculated from hemoglobin concentration, oxygen saturation, and partial pressure of oxygen.
Unit of Measure: mL O₂/dL blood
Measured: Measurements were performed before the intervention and at 7 days after the intervention.
Secondary outcomes (1)
Blood lactic acid level
Measurement of serum lactic acid concentration. Unit of Measure: mmol/L
Measured: Measurements were performed before the intervention and at 7 days after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen, Yao-Hsiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen, Yao-Hsiang, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586345
- Sponsor's protocol ID
- TSGH-SS_D_115024
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 14 May 2026
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Different Nebulized Solutions on Airway Clearance Function in Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT07586345
- Acronym / sponsor ID
- TSGH-SS_D_115024
- Conditions
- Pneumonia, Airway Clearance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chen, Yao-HsiangUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 May 2026 (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.
Pneumonia is a significant global and national health issue, particularly posing a notable threat to elderly population. Accumulation of sputum in pneumonia patients often results in impaired airway clearance, negatively impacting disease management and recovery. Clinically, nebulization therapy is widely employed to facilitate sputum clearance; however, evidence regarding the comparative effectiveness of different nebulized solution concentrations remains limited and inconsistent. Therefore, this study aims to evaluate and compare the clinical effects of nebulized solutions with various osmotic concentrations (3% hypertonic saline, 0.9% normal saline, 0.45% hypotonic saline, and distilled water) on airway clearance in patients with pneumonia. A randomized, double-blind controlled trial design will be used, recruiting 80 patients with pneumonia from a regional teaching hospital in northern Taiwan. Participants will be randomly assigned into four groups, receiving nebulized therapy four times daily over a period of seven days. This study outcome including the length of hospital stay, venous blood gas analysis, routine sputum examination, and arterial oxygen content. The findings of this the study are anticipated to provide evidence-based recommendations for the clinical application of nebulized solutions with different concentrations, aiming to enhance airway clearance efficiency, improve clinical care outcomes for pneumonia patients, and serve as a practical reference for healthcare professionals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Nebulization therapy |
| Hypertonic group | Active comparator | Other: Nebulization therapy |
| Isotonic group | Active comparator | Other: Nebulization therapy |
| Hypotonic group | Active comparator | Other: Nebulization therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with pneumonia, defined by ICD-10 codes, including:
- J18: Pneumonia, unspecified organism J180: Bronchopneumonia, unspecified organism J181: Lobar pneumonia, unspecified organism J182: Hypostatic pneumonia, unspecified organism J188: Other pneumonia, unspecified organism J189: Pneumonia, unspecified organism
- Aged 18-100 years
- Clinical respiratory score > 3
- Patients unable to expectorate sputum spontaneously and requiring assisted suctioning
Key exclusion criteria (10 listed)
- Diagnosis of influenza-associated pneumonia, defined by ICD-10 codes, including:
- J09X1: Influenza due to identified novel influenza A virus with pneumonia J1001: Influenza due to other identified influenza virus with the same identified influenza viral pneumonia J100: Influenza due to other identified influenza virus with pneumonia
- Diagnosis of COVID-19 infection, defined by ICD-10 code:
- U07.1: COVID-19, virus identified
- History of chronic obstructive pulmonary disease (COPD) (ICD-10 code: J44)
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 |
|---|---|---|
| Nebulization therapyComparison of different concentrations of saline solutions used for nebulization therapy | Other | Control Group, Hypertonic group, Hypotonic group, Isotonic group |
Primary outcome
Vein blood gas
Time frame: Measurements were performed before the intervention and at 7 days after the intervention.
Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.
Sputum routine examination
Time frame: Measurements were performed before the intervention and at 7 days after the intervention.
Assessment of sputum characteristics and routine laboratory findings.
Arterial oxygen content (CaO₂)
Time frame: Measurements were performed before the intervention and at 7 days after the intervention.
Measurement of arterial oxygen content calculated from hemoglobin concentration, oxygen saturation, and partial pressure of oxygen. Unit of Measure: mL O₂/dL blood
1 secondary outcome
Blood lactic acid level
Time frame: Measurements were performed before the intervention and at 7 days after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
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 Nebulization therapy in people with Pneumonia and Airway Clearance, run by Chen, Yao-Hsiang.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 14 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Vein blood gas (time frame: Measurements were performed before the intervention and at 7 days after the intervention.). 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?
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 14 May 2026.