No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
COPD Foundation · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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 maintenan…
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
Contacts
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