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The long term effect of nebulized saline for non-cystic fibrosis bronchiectasis: A randomized controlled trial

The long term effect of nebulized saline for non-cystic fibrosis bronchiectasis: A randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093811
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-12-13
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

bronchiectasis

Interventions

Hypertonic saline group:Conventional treatment, nebulized inhalation of 8ml of 7% hypertonic saline solution, bid, inhaled 200ug of salbutamol before nebulization, for a total of 48 weeks.
Isotonic saline group:Conventional treatment, nebulized inhalation of 8ml of 0.9% isotonic saline solution, bid, inhaled 200ug of salbutamol before nebulization, for a total of 48 weeks.
Control group:Conventional treatment lasts for 48 weeks.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: According to the "Expert Consensus on Diagnosis and Treatment of Adult Bronchiectasis in China" released by the Infectious Diseases Group of the Respiratory Disease Branch of the Chinese Medical Association in 2021, patients diagnosed with bronchiectasis through high- resolution CT scan. According to the "Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Bronchiectasis" released by the Respiratory Disease Professional Committee of the World Federation of Chinese Medicine Societies in 2022, the diagnosis is "phlegm heat obstructing the lungs" or "phlegm dampness obstructing the lungs". Age >= 18 years old. At least 2 times of acute exacerbation have occurred in the past year. Coughing occurred daily for the 14 days prior to inclusion. During the 14 days prior to the inclusion, the condition of bronchiectasis remained stable without any medication adjustments. Agree to maintain the long-term medication regimen as unchanged as possible during the study period. The patient or their authorized representative signs the informed consent form.

Exclusion criteria

Exclusion criteria: Suffering from cystic fibrosis. Chronic obstructive pulmonary disease is the main diagnosis. Asthma is the main diagnosis. Smokers who have not quit smoking. The forced expiratory volume in one second (FEV1) is less than 30%. Receiving saline nebulization or used expectorants in the past 30 days. Saline atomization intolerance. Pregnant or breastfeeding women. Currently participating in other treatment-related clinical trials. After saline atomization, FEV1 decreased by more than 15%.

Design outcomes

Primary

MeasureTime frame
Acute exacerbation frequency;

Secondary

MeasureTime frame
Days of antibiotic use associated with acute exacerbation;Efficacy Evaluation Scale for Phlegm Turbidity Syndrome;quality of life with bronchiectasis questionnaire;EuroQol five dimensions questionnaire;Leicester cough questionnaire;St. Georges respiratory questionnaire;

Countries

China

Contacts

Public ContactYuebo Song

China-Japan Friendship Hospital

yb_song0505@126.com+86 158 1125 8870

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026