Recruiting

Nebulized Therapy

Sponsor:

COPD Foundation

Code:

NCT07816835

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Nebulized therapy of similar medication solutions

Continue handheld therapy

Study Details

Brief summary:

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Chronic Obstructive Pulmonary Disease (COPD)

Study ID

NCT07816835

Start date

Jul 14, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Handheld Inhaler Group

Subjects continue with their current maintenance handheld inhaler regimen

active comparator: Nebulizer Group

Subjects switched to nebulized therapy using similar medication solutions

Interventions

Nebulized therapy of similar medication solutions

LABA/LAMA or LABA/LAMA/ICS nebulized solutions

Continue handheld therapy

Continue with current handheld LABA/LAMA or LABA/LAMA/ICS therapy

Primary outcome measure

  • Transition Dyspnea Index [ Time Frame: 28 (+/- 2) days ]

Central Contacts and Locations

Locations

Midwest Chest Consultants, P.C.

Recruiting

Saint Charles, Missouri, United States, 63301

Contacts

Thomas M Siler, MD

636-946-1650thomas.siler.md@midwestchest.com

Southeastern Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Benjamin Bregman, MD

336-659-8414bbregman@southeasternresearchcenter.com

More Information

Sponsor

COPD Foundation

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • COPD, BDI, TDI
  • COPD maintenance therapy
  • Nebulizer therapy
  • LABA/LAMA
  • LABA/LAMA/ICS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by COPD Foundation on 2026-09-14.