Active — Not RecruitingNot Applicable

PEP and O-PEP Device for Nebulization in Cystic Fibrosis

Poland70 participantsStarted 2022-01-01

Plain-language summary

Physiotherapy is an essential element in the comprehensive treatment of patients with cystic fibrosis. In symptomatic individuals, from a respiratory system perspective, it should be performed regularly, as it directly contributes to slowing disease progression. Even though patients perform airway-clearing physical therapy daily, it should be intensified during exacerbations. Although solutions for effectively clearing the airways have been sought for many years, there is still no leading technique for removing secretions from the respiratory tract. Modifications during inhalation aimed at thinning and loosening the accumulated thick mucus can facilitate the effective mobilization and expectoration of secretions, thus improving patients' quality of life.

Who can participate

Age range10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * written consent of the patient and/or guardian, * no disease complications (within the last 2 months) in the form of: active haemoptysis, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media, * Age above 10 years, * the ability to perform correctly lung function tests and FEV1 value above 20% predicted, * the presence of respiratory symptoms indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in FEV1 by 10% or more from a previously recorded value. Exclusion Criteria: * Lack of written consent for the study * Hemoptysis within the last 2 months * History of pneumothorax * Current otitis media * Age below 10 years * FEV1 value below 20% of the predicted value * Surgical procedures in the area of the oesophagus (esophageal varices) * Intolerance to the PEP or O-PEP device

What they're measuring

1. Pulmonary Function Test (PFT)

Timeframe: From baseline to study completion, the average duration is 10 days.

1. Pulmonary Function Test (PFT)

Timeframe: From baseline to study completion, the average duration is 10 days.

1.2 Pulmonary Function Test (PFT)

Timeframe: From baseline to study completion, the average duration is 10 days.

Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Timeframe: From baseline to study completion, the average duration is 10 days.

Trial details

NCT IDNCT06964074

SponsorNational Institute for Tuberculosis and Lung Diseases, Poland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Cystic Fibrosis trials

Plain-language summary

Who can participate

Age range10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

1. Pulmonary Function Test (PFT)

Timeframe: From baseline to study completion, the average duration is 10 days.

1. Pulmonary Function Test (PFT)

Timeframe: From baseline to study completion, the average duration is 10 days.

1.2 Pulmonary Function Test (PFT)

Timeframe: From baseline to study completion, the average duration is 10 days.

Survey Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Timeframe: From baseline to study completion, the average duration is 10 days.