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

NCT03219866 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: IRB00042362
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

COPD; COPD Exacerbation

Keywords

Nebulizer; Inhaler

Outcome Measures

Primary Outcomes (1)

• Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)

  Scores range from 0 to 100, with higher scores indicating more limitations - Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall

  90 Days

Secondary Outcomes (8)

• Symptom Control Measured by the COPD Assessment Test (CAT)

  90 Days

• Symptom Control Measured by The Modified Medical Research Council Dyspnea Scale (mMRC)

  90 Days

• COPD and All-Cause Hospital Readmissions After 30 Days

  30 Days

• COPD and All-Cause Hospital Readmissions After 90 Days

  90 Days

• Unscheduled Clinic or ER Visits

  90 Days

Study Arms (2)

Nebulizers

EXPERIMENTAL

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; Drug: Brovana; Drug: Pulmicort; Drug: Atrovent

Dry Powder Inhaler

EXPERIMENTAL

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

Device: Dry Powder Inhaler; Drug: Advair Diskus; Drug: Spiriva HandiHaler

Interventions

Nebulizers DEVICE

Patients treated and discharged on nebulized bronchodilators

Also known as: Nebulizer Arm

Nebulizers

Dry Powder Inhaler DEVICE

Patients treated and discharged on Dry Powder Inhalers

Also known as: DPI Arm

Dry Powder Inhaler

Brovana DRUG

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

Also known as: LABA

Nebulizers

Pulmicort DRUG

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

Also known as: ICS

Nebulizers

Atrovent DRUG

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

Also known as: SAMA

Nebulizers

Advair Diskus DRUG

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

Also known as: LABA, ICS

Dry Powder Inhaler

Spiriva HandiHaler DRUG

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

Also known as: LAMA

Dry Powder Inhaler

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

Related Publications (12)

• Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary disease among adults--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Nov 23;61(46):938-43.

  PMID: 23169314 BACKGROUND

• Pauwels RA, Buist AS, Ma P, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care. 2001 Aug;46(8):798-825. No abstract available.

  PMID: 11463370 BACKGROUND

• Pleasants RA, Ohar JA, Croft JB, Liu Y, Kraft M, Mannino DM, Donohue JF, Herrick HL. Chronic obstructive pulmonary disease and asthma-patient characteristics and health impairment. COPD. 2014 Jun;11(3):256-66. doi: 10.3109/15412555.2013.840571. Epub 2013 Oct 23.

  PMID: 24152212 BACKGROUND

• Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of chronic obstructive pulmonary disease in the USA. Clinicoecon Outcomes Res. 2013 Jun 17;5:235-45. doi: 10.2147/CEOR.S34321. Print 2013.

  PMID: 23818799 BACKGROUND

• Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.

  PMID: 18836213 BACKGROUND

• Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.

  PMID: 19716960 BACKGROUND

• Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9.

  PMID: 18614347 BACKGROUND

• Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12.

  PMID: 24429127 BACKGROUND

• Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012 Jul;64(3):450-504. doi: 10.1124/pr.111.004580. Epub 2012 May 18.

  PMID: 22611179 BACKGROUND

• Cazzola M, Molimard M. The scientific rationale for combining long-acting beta2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther. 2010 Aug;23(4):257-67. doi: 10.1016/j.pupt.2010.03.003. Epub 2010 Apr 8.

  PMID: 20381630 BACKGROUND

• 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.

  PMID: 23025451 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Nebulizers and Vaporizers; Dry Powder Inhalers; Formoterol Fumarate; Budesonide; Ipratropium; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Salmeterol Xinafoate; Albuterol; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Jill Ohar, MD
• Organization: Wake Forest Health Science

johar@wakehealth.edu

336-716-1210

Study Officials

• Jill A Ohar, MD, FCCP

  Professor of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: October 3, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 22, 2021
• Results First Posted: June 10, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)