asal high flow therapy in bronchiectasis

Not Applicable

Active, not recruiting

• Conditions: Bronchiectasis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621001122842
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-23
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Aged 18 years or over, Able to provide written informed consent, Able to provide spontaneous sputum samples, High-resolution CT (HRCT) chest scan confirming diagnosis of bronchiectasis, within the past 5 years, Clinically stable during baseline period, for 4 weeks prior to commencement of, treatment (defined as the absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone, with stable spirometry), History of one or more pulmonary exacerbations requiring antibiotics in the past 12 months. Patients with asthma and COPD will be included only if the primary diagnosis is bronchiectasis.; Aged 18 years or over, Able to provide written informed consent, Able to provide spontaneous sputum samples, High-resolution CT (HRCT) chest scan confirming diagnosis of bronchiectasis, within the past 5 years, Clinically stable during baseline period, for 4 weeks prior to commencement of, treatment (defined as the absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone, with stable spirometry), History of one or more pulmonary exacerbations requiring antibiotics in the past 12 months. Patients with asthma and COPD will be included only if the primary diagnosis is bronchiectasis.

Exclusion Criteria

Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment. Patients with a history of non-compliance with treatment/management. Patients with significant medical conditions other than bronchiectasis: A significant disease is one that would, in the opinion of the investigator, put the participant at risk through participation in the study, or a disease that may influence the results of the study, or the participant’s ability to participate in the study. Patients with cystic fibrosis. Patients with primary ciliary dyskinesia. Patients with hypogammaglobulinaemia. Patients with allergic bronchopulmonary aspergillosis (total IgE greater than 420 IU/ml Aspergillus specific IgE level of 3+ or 4+, and proximal bronchiectasis on HRCT). Patients taking immunosuppressive agents (e.g., azathioprine, methotrexate, cyclophosphamide) or long term corticosteroid therapy. Patients with other primary or acquired immunodeficiency. Patients on long term oxygen therapy. Patients with evidence of active or suspected cancer and patients having undergone cancer treatment including resection, radiation therapy or chemotherapy within the last 2 years (patients with basal cell carcinoma and squamous cell carcinoma are allowed). Pregnant or lactating women. Participation in a separate clinical or device trial within 4 weeks of screening. Anatomical factors or other considerations such as claustrophobia that would make using the NHF equipment difficult or uncomfortable for the patient.; Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment. Patients with a history of non-compliance with treatment/management. Patients with significant medical conditions other than bronchiectasis: A significant disease is one that would, in the opinion of the investigator, put the participant at risk through participation in the study, or a disease that may influence the results of the study, or the participant’s ability to participate in the study. Patients with cystic fibrosis. Patients with primary ciliary dyskinesia. Patients with hypogammaglobulinaemia. Patients with allergic bronchopulmonary aspergillosis (total IgE greater than 420 IU/ml Aspergillus specific IgE level of 3+ or 4+, and proximal bronchiectasis on HRCT). Patients taking immunosuppressive agents (e.g., azathioprine, methotrexate, cyclophosphamide) or long term corticosteroid therapy. Patients with other primary or acquired immunodeficiency. Patients on long term oxygen therapy. Patients with evidence of active or suspected cancer and patients having undergone cancer treatment including resection, radiation therapy or chemotherapy within the last 2 years (patients with basal cell carcinoma and squamous cell carcinoma are allowed). Pregnant or lactating women. Participation in a separate clinical or device trial within 4 weeks of screening. Anatomical factors or other considerations such as claustrophobia that would make using the NHF equipment difficult or uncomfortable for the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sputum neutrophil elastase level[ Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week, primary endpoint), End Period 2 visit (28 week).];Sputum neutrophil elastase level[ Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week, primary endpoint), End Period 2 visit (28 week).]