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Trial record 5 of 56 for:    forest COPD

Nebulizer Versus Dry Powdered Inhalers for COPD

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ClinicalTrials.gov Identifier: NCT03219866
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

This will be a non-blinded feasibility (pilot) study comparing triple therapy nebulizer vs dry powdered inhalers (DPI) for care transitions in 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.

Condition or disease Intervention/treatment Phase
COPD COPD Exacerbation Device: Nebulizers Device: Dry Powder Inhaler Drug: Brovana Drug: Pulmicort Drug: Atrovent Drug: Advair Diskus Drug: Spiriva HandiHaler Phase 4

Detailed Description:
Drugs used to treat 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study for Comparison of Triple Therapy Nebulizer Versus Dry Powdered Inhaler for Care Transitions in COPD
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: 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).
Device: Nebulizers
Patients treated and discharged on nebulized bronchodilators
Other Name: Nebulizer Arm
Drug: Brovana
Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
Other Name: LABA
Drug: Pulmicort
Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
Other Name: ICS
Drug: Atrovent
Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
Other Name: SAMA
Experimental: Dry Powder Inhaler
Subjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily).
Device: Dry Powder Inhaler
Patients treated and discharged on Dry Powder Inhalers
Other Name: DPI Arm
Drug: Advair Diskus
Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Other Name: LABA, ICS
Drug: Spiriva HandiHaler
Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
Other Name: LAMA



Primary Outcome Measures :
  1. Quality of Life measured by SGRQ [ Time Frame: 90 Days ]
    The Saint George Respiratory Questionnaire measures health impairment in patients with asthma and COPD. Each component of the questionnaire is scored separately in 3 steps: The weights for all items with a positive responses are summed, the weights for missed items are deducted, and the score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage: Score=100 x Summed weights from positive items in that component. The Total score is calculated in similar way: Score=100 x Summed weights from positive items in the questionnaire. Sum of maximum possible weights for each component and Total: Symptom=662.5, Activity=1209.1, Impacts=2117.8, Total=3989.4 (these are the maximum possible weights that could be obtained for the worst possible state of the patient). Thus a higher score would represent a worse outcome, as the state of the patient is deemed worse than if they have a lower score.


Secondary Outcome Measures :
  1. Symptom Control measured by CAT [ Time Frame: 90 Days ]
    The COPD Assessment Test (CAT) is a patient-completed instrument that can quantify the impact of COPD on the patient's health. The CAT is a validated, short (8-item) and simple patient completed questionnaire.The CAT has a scoring range of 0-40 and a difference or change of 2 or more units over 2 to 3 months in a patient suggests a clinically significant difference or change in health status. A score of >30 indicates that COPD has a very high impact on daily life, a score of >20 indicates a high impact, 10-20 is medium impact, <10 is low impact, and 5 is the upper limit for healthy non-smokers. A higher score would represent a poor outcome for this test.

  2. Symptom Control measured by mMRC [ Time Frame: 90 Days ]
    The Modified Medical Research Council Dyspnea Scale, or MMRC, uses a simple grading system to assess a patient's level of dyspnea -- shortness of breath. The scale goes from 0-4 with a 0 = I only get breathless with strenuous exercise, 1 = I get short of breath when hurrying on level ground or walking up a slight hill, 2 = On level ground, I walk slower than people of the same age because of breathlessness or have to stop for breath when walking at my own pace, 3 = I stop for breath after walking about 100 yards or after a few minutes on level ground, and 4 = I am too breathless to leave the house or I am breathless when dressing. 4 would represent the worst outcome.

  3. COPD and All-Cause Hospital Readmissions after 30 Days [ Time Frame: 30 Days ]
    Compare the number of hospital readmissions between the two arms after 30 days of using each device.

  4. COPD and All-Cause Hospital Readmissions after 90 Days [ Time Frame: 90 Days ]
    Compare the number of hospital readmissions between the two arms after 90 days of using each device.

  5. Unscheduled Clinic of ER visits [ Time Frame: 90 Days ]
    Compare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device

  6. PIF measured at baseline during hospitalization and at each study visit [ Time Frame: 90 Days ]
    Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219866


Contacts
Contact: Jill A Ohar, MD, FCCP 336-716-1210 johar@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Jill A Ohar, MD, FCCP    336-716-1210    johar@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Jill A Ohar, MD, FCCP Professor of Internal Medicine

Publications:
Loh CH, Lovings T, Ohar JA . Low Inspiratory Flow Rates Predict COPD and All Cause Readmissions. ATS Abstract;2016;In press

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03219866     History of Changes
Other Study ID Numbers: IRB00042362
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Wake Forest University Health Sciences:
Nebulizer
Inhaler

Additional relevant MeSH terms:
Tiotropium Bromide
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Budesonide
Ipratropium
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents