Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT03219866

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2020-04-01

Brief Summary

This will be a non-blinded feasibility (pilot) study comparing triple therapy nebulizer vs dry powdered inhalers (DPI) for care transitions in Chronic obstructive pulmonary disease (COPD) exacerbation patients.

We hypothesize that patients treated in hospital and discharged on respiratory medications administered by nebulizers will exhibit better quality of life (QoL), symptom control, and lower COPD and all cause hospital readmission rates compared with patients treated with respiratory medications delivered by DPI.

We aim to demonstrate that:

1. Patients treated and discharged on nebulized bronchodilators will have fewer readmissions to hospital at 30 and 90 days compared to the group utilizing DPI

2. The nebulizer group will demonstrate a longer duration of time until hospital readmission for COPD and all cause readmission compared to the group utilizing DPI

3. The nebulizer group will demonstrate better QoL (measured by the SGRQ - Saint George Respiratory Questionnaire) and symptom control (as measured by the CAT & mMRC) compared to the group utilizing DPI.

Detailed Description

Drugs used to treat Chronic obstructive pulmonary disease (COPD) are available primarily in hand held inhaler devices that deliver dry powder (DPI), a soft mist or a metered dose of spray (MDI). The frail, arthritic elderly are often prescribed DPI rather than MDI or soft mist devices, because they require less coordination. DPIs however require the ability to inhale against a resistance with a peak inspiratory force (PIF) more negative than 60 L/min to break the dry powder into respirable particles. Preliminary data suggests that suboptimal PIF's are common during an acute exacerbation of COPD, affecting 48% of hospitalized patients, thus placing them at risk for treatment failure and possibly hospital readmission. Use of nebulizers to administer respiratory medications may avoid the hazards of insufficient dosing that can result from use of DPI however they are cumbersome, expensive and the variety of drugs available in a nebulizer format is limited. We hypothesize that patients treated in hospital and is charged on respiratory medications administered by nebulizers will exhibit better symptom control and lower COPD and all cause hospital readmission rates compared with patients treated with respiratory medications delivered by DPI. We aim to demonstrate that 1) patients treated and discharged on nebulized bronchodilators will have fewer readmissions to hospital at 30 and 90 days compared to the group utilizing DPI 2) that the nebulizer group will demonstrate a longer duration of time till hospital readmission for COPD and all cause readmission compared to the group utilizing DPI and 3) the nebulizer group will demonstrate better symptom control compared to the group utilizing DPI. This nonblinded feasibility (pilot) study will enroll 100 patients hospitalized for an exacerbation of COPD who are > 40 years of age, have a clinical diagnosis of COPD. The study will consist of 3 outpatient visits (Transitional Care Visit [314 days after discharge], Visit #2 [30 +/5 days after discharge], and Visit #3 [90 +/5 days after discharge]). Visit #2 and #3 are for study purposes, the Transitional Care Visit is standard of care. We hypothesize and aim to demonstrate that patients treated in hospital and discharged on respiratory medications administered by nebulizers will exhibit better quality of life (QoL), symptom control and lower COPD and all cause hospital readmission rates compared with patients treated with respiratory medications delivered by DPI.

Conditions

COPD; COPD Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nebulizers

Subjects will receive a long-acting B2-agonist (LABA; Brovana, twice daily), corticosteroid (ICS; Pulmicort, twice daily), and a short-acting anti-cholinergic (SAMA; Atrovent, three times a day).

Group Type: EXPERIMENTAL

Nebulizers

Intervention Type: DEVICE

Patients treated and discharged on nebulized bronchodilators

Brovana

Intervention Type: DRUG

Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)

Pulmicort

Intervention Type: DRUG

Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)

Atrovent

Intervention Type: DRUG

Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)

Dry Powder Inhaler

Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).

Group Type: EXPERIMENTAL

Dry Powder Inhaler

Intervention Type: DEVICE

Patients treated and discharged on Dry Powder Inhalers

Advair Diskus

Intervention Type: DRUG

Subjects will receive a LABA/ICS (Advair Diskus, twice daily)

Spiriva HandiHaler

Intervention Type: DRUG

Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)

Interventions

Nebulizers

Patients treated and discharged on nebulized bronchodilators

Intervention Type: DEVICE

Dry Powder Inhaler

Patients treated and discharged on Dry Powder Inhalers

Intervention Type: DEVICE

Brovana

Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)

Intervention Type: DRUG

Pulmicort

Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)

Intervention Type: DRUG

Atrovent

Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)

Intervention Type: DRUG

Advair Diskus

Subjects will receive a LABA/ICS (Advair Diskus, twice daily)

Intervention Type: DRUG

Spiriva HandiHaler

Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)

Intervention Type: DRUG

Other Intervention Names

Nebulizer Arm; DPI Arm; LABA; ICS; SAMA; LABA, ICS; LAMA

Eligibility Criteria

Inclusion Criteria

• > 40 years of age
• Clinical diagnosis of COPD
• Smoking history > 10 pack years
• Lung Function- FEV1/FVC or FEV1/SVC < 70% on bedside spirometry or previous baseline and FEV1/FVC or FEV1/SVC < 70% on clinic visit < 2 weeks from discontinuation
• Able to give informed consent

Exclusion Criteria

• Dementia
• Active cancer
• End stage cardiovascular disease
• Inability to attend outpatient visits
• Active Schizophrenia

Pregnancy; subjects will be excluded if female and are not post-menopausal for at least one year. Since there is no possible benefit from participating in this protocol for a pregnant woman, we will exclude pregnant women. If a subject is found to be pregnant during the 90-day study period, they will be excluded from the study and their data not used for study purposes.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill A Ohar, MD, FCCP

Role: PRINCIPAL_INVESTIGATOR

Professor of Internal Medicine

Locations

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Mahler DA, Waterman LA, Gifford AH. Prevalence and COPD phenotype for a suboptimal peak inspiratory flow rate against the simulated resistance of the Diskus(R) dry powder inhaler. J Aerosol Med Pulm Drug Deliv. 2013 Jun;26(3):174-9. doi: 10.1089/jamp.2012.0987. Epub 2012 Oct 1.

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00042362

Identifier Type: -

Identifier Source: org_study_id