RightFit
RecruitingPhase 4

Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether switching to a nebulizer helps people with COPD who say their daily handheld inhalers do not ease their symptoms. A nebulizer turns medicine into a mist to breathe in. The study compares similar types of medicines for COPD, a long-term lung disease that makes breathing hard.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have smoked more than 10 pack-years of cigarettes—for example, 1 pack a day for more than 10 years.
  • Have COPD diagnosed using the GOLD medical guidelines.
  • Have had a stable health condition for the past 4 weeks.
  • Had a breathing test in the past 12 months showing FEV1 below 50% of the expected level. FEV1 is how much air you can blow out in 1 second. The test must have been done 30 minutes after albuterol or 2–4 hours after a long-acting daily inhaler.
  • Have used one pressurized spray inhaler or one dry-powder inhaler for at least 1 month. It must contain two long-acting medicines that open the airways (LABA/LAMA), with or without an inhaled steroid (ICS).

Who can't join

  • Have dementia or a known problem with memory or thinking.
  • Have trouble using your hands, such as from severe rheumatoid arthritis or severe shaking.
  • Had a COPD flare-up in the past 2 months.
  • Have another lung or breathing disease, including asthma.
  • Use a slow-mist inhaler with LABA/LAMA medicines.
  • Use short-acting nebulizer medicines (SABA/SAMA) 3–4 times a day as regular daily treatment.
  • Take prednisone every day to treat COPD.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (2)

MO

NC