COPDPhase 4NCT03219866
Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Nebulizers, Dry Powder Inhaler and Brovana in people with COPD and COPD Exacerbation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- Nebulizers, Dry Powder Inhaler and Brovana
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 1 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
Official title: Preliminary Study for Comparison of Triple Therapy Nebulizer Versus Dry Powdered Inhaler for Care Transitions in COPD
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.
Read more
We aim to demonstrate that:
- Patients treated and discharged on nebulized bronchodilators will have fewer readmissions to hospital at 30 and 90 days compared to the group utilizing DPI
- 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
- 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.
Read the 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
- Being tested
- Nebulizers, Dry Powder Inhaler, Brovana, Pulmicort, Atrovent
- Keywords
- Nebulizer, Inhaler
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebulizersDevice
Also called Nebulizer Arm
Patients treated and discharged on nebulized bronchodilators
Dry Powder InhalerDevice
Also called DPI Arm
Patients treated and discharged on Dry Powder Inhalers
BrovanaDrug
Also called LABA
Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
PulmicortDrug
Also called ICS
Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
AtroventDrug
Also called SAMA
Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
Advair DiskusDrug
Also called LABA, ICS
Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
Spiriva HandiHalerDrug
Also called LAMA
Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Dry Powder Inhaler; Drug: Advair Diskus; Drug: Spiriva HandiHaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 Days
Secondary outcomes (8)
Symptom Control Measured by the COPD Assessment Test (CAT)
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.
Measured: 90 Days
Symptom Control Measured by The Modified Medical Research Council Dyspnea Scale (mMRC)
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.
Measured: 90 Days
COPD and All-Cause Hospital Readmissions After 30 Days
Compare the number of hospital readmissions between the two arms after 30 days of using each device.
Measured: 30 Days
COPD and All-Cause Hospital Readmissions After 90 Days
Compare the number of hospital readmissions between the two arms after 90 days of using each device.
Measured: 90 Days
Unscheduled Clinic or ER Visits
Compare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device
Measured: 90 Days
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -2 (Low to Medium Resistance Inhalers)
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
Measured: Baseline and 90 days
Number of Deaths
Measured: 90 days
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -5 (High Resistance Inhalers)
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study.
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start3 Oct 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Lower enrollment than Sponsor expected - Sponsor stopped study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill A Ohar, MD, FCCP, Principal investigator, Professor of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219866
- Sponsor's protocol ID
- IRB00042362
- Status last verified
- Sep 2020
- First submitted
- 12 Jul 2017
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23169314Pauwels 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.
PubMed 11463370Pleasants 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.
PubMed 24152212Guarascio 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.
PubMed 23818799Tashkin 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.
PubMed 18836213Calverley 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.
PubMed 19716960Ferguson 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.
PubMed 18614347Dransfield 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.
PubMed 24429127Cazzola 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.
PubMed 22611179Cazzola 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.
PubMed 20381630Mahler 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.
PubMed 23025451Loh CH, Lovings T, Ohar JA . Low Inspiratory Flow Rates Predict COPD and All Cause Readmissions. ATS Abstract;2016;In press
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study for Comparison of Triple Therapy Nebulizer Versus Dry Powdered Inhaler for Care Transitions in COPD
- ClinicalTrials.gov ID
- NCT03219866
- Acronym / sponsor ID
- IRB00042362
- Conditions
- COPD, COPD Exacerbation
- Keywords
- Nebulizer, Inhaler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower enrollment than Sponsor expected - Sponsor stopped study
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 10 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients treated and discharged on nebulized bronchodilators will have fewer readmissions to hospital at 30 and 90 days compared to the group utilizing DPI
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulizers | Experimental | Device: Nebulizers, Drug: Brovana, Drug: Pulmicort, Drug: AtroventSubjects 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). |
| Dry Powder Inhaler | Experimental | Device: Dry Powder Inhaler, Drug: Advair Diskus, Drug: Spiriva HandiHalerSubjects will receive a LABA/ICS (Advair Diskus, twice daily) plus a long-acting anticholinergic (LAMA; Spiriva Handihaler, once daily). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (6 listed)
- Dementia
- Active cancer
- End stage cardiovascular disease
- Inability to attend outpatient visits
- Active Schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NebulizersAlso: Nebulizer ArmPatients treated and discharged on nebulized bronchodilators | Device | Nebulizers |
| Dry Powder InhalerAlso: DPI ArmPatients treated and discharged on Dry Powder Inhalers | Device | Dry Powder Inhaler |
| BrovanaAlso: LABASubjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily) | Drug | Nebulizers |
| PulmicortAlso: ICSSubjects will receive a corticosteroid (ICS; Pulmicort, twice daily) | Drug | Nebulizers |
| AtroventAlso: SAMASubjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day) | Drug | Nebulizers |
| Advair DiskusAlso: LABA, ICSSubjects will receive a LABA/ICS (Advair Diskus, twice daily) | Drug | Dry Powder Inhaler |
| Spiriva HandiHalerAlso: LAMASubjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily) | Drug | Dry Powder Inhaler |
Primary outcome
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
Time frame: 90 Days
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
8 secondary outcomes
Symptom Control Measured by the COPD Assessment Test (CAT)
Time frame: 90 Days
Symptom Control Measured by The Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: 90 Days
COPD and All-Cause Hospital Readmissions After 30 Days
Time frame: 30 Days
COPD and All-Cause Hospital Readmissions After 90 Days
Time frame: 90 Days
Unscheduled Clinic or ER Visits
Time frame: 90 Days
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -2 (Low to Medium Resistance Inhalers)
Time frame: Baseline and 90 days
Number of Deaths
Time frame: 90 days
Change in Pulmonary Inspiratory Force (PIF) From Baseline at 90 Days - R -5 (High Resistance Inhalers)
Time frame: Baseline and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23169314Centers 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.
- Background: PubMed 11463370Pauwels 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.
- Background: PubMed 24152212Pleasants 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.
- Background: PubMed 23818799Guarascio 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.
- Background: PubMed 18836213Tashkin 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.
- Background: PubMed 19716960Calverley 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.
- Background: PubMed 18614347Ferguson 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.
- Background: PubMed 24429127Dransfield 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.
- Background: PubMed 22611179Cazzola 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.
- Background: PubMed 20381630Cazzola 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.
- Background: PubMed 23025451Mahler 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.
- BackgroundLoh CH, Lovings T, Ohar JA . Low Inspiratory Flow Rates Predict COPD and All Cause Readmissions. ATS Abstract;2016;In press
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill A Ohar, MD, FCCP principal investigator
Professor of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulizers, Dry Powder Inhaler and Brovana in people with COPD and COPD Exacerbation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ) (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219866, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.