Health TrialsbyHealthPanel

Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

ConditionsCOPD (Chronic Obstructive Pulmonary Disease)Chronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorCOPD Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nebulized therapy of similar medication solutions

    Device

    LABA/LAMA or LABA/LAMA/ICS nebulized solutions

  • Continue handheld therapy

    Device

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Handheld Inhaler GroupOther 1 intervention
Group B: Nebulizer GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Transition Dyspnea Index

Measurement of dyspnea

Time frame
28 (+/- 2) days

Secondary outcomes

1

FEV1 and FVC

Changes in lung function

Time frame
28 (+/- 2) days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

COPD Foundation

Lead sponsor

Viatris Specialty LLC

Collaborator

PARI Respiratory Equipment, Inc.

Collaborator

Theravance Biopharma

Collaborator

Source ClinicalTrials.gov
Apply now