None listed
Conditions
Brief summary
This study aims to evaluate whether inhalation therapy can improve symptoms and quality of life in people with chronic obstructive pulmonary disease (COPD) who are in a stable phase but continue to have thick sputum and cough. The study compares two commonly used inhalation treatments: a 3% hypertonic saline solution alone and the same solution combined with 0.1% hyaluronic acid . We hypothesize that adding hyaluronic acid will provide additional benefits, particularly by reducing shortness of breath and improving daily physical activity, while remaining safe and well tolerated. Participants will receive one of the two treatments via a nebulizer for 10 days in addition to their usual COPD therapy. The study will assess changes in respiratory symptoms, quality of life, and lung function before and after treatment. The results may help identify a more effective and comfortable inhalation option for people living with COPD.
Interventions
The use of inhalation therapy via nebulizer for the purpose of thinning and facilitating the clearance of viscous sputum from the airways.
Arm 1. In the first group, patients will receive 4 mL of 3% sodium chloride solution via nebulizer two times per day for 10 days.
Arm 2. In the second group, patients will receive a combination of 3% sodium chloride solution and 0.1% sodium hyaluronate solution for nebulized therapy, 4 mL two times per day 10 days. Treatment will be administered on an outpat
The use of inhalation therapy via nebulizer for the purpose of thinning and facilitating the clearance of viscous sputum from the airways. Arm 1. In the first group, patients will receive 4 mL of 3% sodium chloride solution via nebulizer two times per day for 10 days. Arm 2. In the second group, patients will receive a combination of 3% sodium chloride solution and 0.1% sodium hyaluronate solution for nebulized therapy, 4 mL two times per day 10 days. Treatment will be administered on an outpatient basis. Participants will receive inhalation therapy using a nebulizer for 10 consecutive days in addition to their usual COPD maintenance therapy. Adherence to the intervention will be monitored using a participant diary, in which patients will record each inhalation session. Study staff will also review adherence during scheduled contacts and at the follow-up visit. Usual COPD therapy (such as bronchodilators or other prescribed medications) will be continued throughout the study according to the treating physician’s recommendations.
Sponsors
Bogomolets National Medical University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1.The patient has provided written informed consent to participate in the trial. 2.Patients diagnosed with COPD, clinical groups B and E, high risk, with more pronounced symptoms (mMRC greater than or equal to 2, CAT greater than or equal to 10), and degree of bronchial obstruction according to GOLD stages 3 to 4 (according to GOLD 2025 recommendations), established at least 12 months prior to the screening visit. 3.Current smokers or former smokers who quit at least 6 months prior to the screening visit and who have smoked for at least 10 years (pack-years calculated as [number of cigarettes per day multiplied by number of years smoked] divided by 20). 4.Post-bronchodilator FEV1 less than 50 percent of the predicted normal value and FEV1/FVC less than 0.7, measured 30 minutes after four inhalations (4 × 100 micrograms) of salbutamol via pressurised metered-dose inhaler (pMDI). 5.Presence of complaints of productive cough with viscous sputum.
Exclusion criteria
1.Pregnant or breastfeeding women. 2.Bronchial asthma: patients with a current diagnosis of bronchial asthma. (Patients with a history of asthma are eligible if they have a current diagnosis of active COPD.) 3.Other respiratory diseases: patients with active tuberculosis, lung cancer, bronchiectasis (note: localized bronchiectasis is not an exclusion criterion), sarcoidosis, primary pulmonary hypertension, interstitial lung diseases, or other severe active pulmonary conditions. 4.Any severe comorbid condition that, in the investigator’s opinion, could affect study outcomes. 5.Patients in a COPD exacerbation requiring systemic glucocorticoids (oral, intravenous, or intramuscular) or antibacterial therapy.
Outcome results
None listed