Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD
Recruiting · NCT07816835 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Continue handheld therapyNebulized therapy of similar medication solutions
What this trial is about
Multi-site, randomized controlled trial to determine whether patients who report NO symptomatic benefit with their maintenance hand-held inhaler(s), benefit upon switching to nebulized therapy using comparable classes of medications.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \> 10 pack-years smoking cigarettes
- Diagnosis of COPD based on GOLD Criteria
- Patients are clinically stable for the past 4 weeks
- Prior Pulmonary function tests showing FEV1 \< 50% predicted (either 30 minutes post albuterol or within 2-4 hours after using their maintenance long-acting inhaler) within the past 12 months.
- Currently using a single pMDI or a single DPI with either LABA/LAMA or LABA/LAMA/ICS therapy for at least one month.
Exclusion criteria
- Current diagnosis of dementia or known cognitive impairment.
- Current impairment in manual dexterity (i.e., severe rheumatoid arthritis, severe tremor, etc)
- Exacerbation of COPD within the last 2 months
- Current diagnosis of other respiratory disease including asthma, treatment with a LABA/LAMA slow mist inhaler or treatment with SABA/SAMA nebulizer medications 3-4 times per day as maintenance therapy
- Current use of daily Prednisone as treatment for COPD
Where it is running
2 locations listed across 2 US states.
- Midwest Chest Consultants, P.C. - Saint Charles, Missouri, United States
- Southeastern Research Center - Winston-Salem, North Carolina, United States