No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
University of Tennessee Graduate School of Medicine · Other
Who this trial is looking for
This trial is looking for people with COPD to compare two ways of taking medication. Participants will use either a nebulizer or an inhaler to see which method is more effective in improving their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 40 years old.
I have symptoms of COPD.
I am a current or former smoker with more than 10 pack-years.
I have a PIFR of over 30.
I have airflow obstruction with a ratio of FEV1/FVC under 70%.
I have significant air trapping with a residual volume over 120%.
You may not be able to join if
I have asthma.
I have had a heart attack in the past 12 weeks.
I have been hospitalized for heart failure recently.
I had an acute COPD flare-up in the past 8 weeks.
I have uncontrolled glaucoma.
I cannot give informed consent.
I am currently pregnant or breastfeeding.
I am already in a pulmonary rehabilitation program.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted).
The investigators hypothesize that, in patients with symptomatic COPD, the…
The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted).
The investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent/long-acting beta agonist (LAMA/LABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA/LABA therapy given by a DPI.
The study aims to demonstrate the following:
1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer
2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline/Transition Dyspnea Index (BDI/TDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \> 40 years
2. Either sex
3. Current smoker or past cigarette smoking history of \> 10 pack-years
4. Symptoms of COPD (cough, sputum production, shortness of breath)
5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening/Run-in vi…
Inclusion Criteria:
1. Age \> 40 years
2. Either sex
3. Current smoker or past cigarette smoking history of \> 10 pack-years
4. Symptoms of COPD (cough, sputum production, shortness of breath)
5. Modified Medical Research Council Dyspnea Scale (mMRC) score ≥2 or CAT score ≥10 at Screening/Run-in visit
6. A PIFR \> 30 at screening
7. FEV1/FVC ratio \< 70% (within the past 12 months)
8. Residual volume (RV) ≥ 120% predicted (within the past 12 months
Exclusion Criteria:
1. Diagnosis of asthma (Verification via medical record and/or patient report)
2. Previously diagnosed atrial fibrillation with rapid ventricular response (heart rate \> 110 bpm) or ventricular arrhythmia (ventricular tachycardia) (Verification via medical record and/or patient report)
3. Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)
4. Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)
5. Acute exacerbation of COPD within 8 weeks (Verification via medical record and/or patient report)
6. Recent (within 8 weeks) h/o eye surgery (Verification via medical record and/or patient report)
7. Uncontrolled glaucoma (Verification via medical record and/or patient report)
8. Known diagnosis of liver cirrhosis (Verification via medical record and/or patient report)
9. Known diagnosis of chronic renal insufficiency (defined as a previous serum creatinine \> 2.5 mg/dL - Verification via medical record and/or patient report)
10. Intolerance to any of the study drugs
11. Patients receiving long-term azithromycin
12. Planned surgery requiring hospital admission within 3 months
13. Currently enrolled in a pulmonary rehabilitation program
14. Inability to give informed consent
15. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants)
16. Inability to understand instructions or comply with the study protocol
17. Participation in another investigational drug clinical trial within 30 days of patient study registration
Medical history can be confirmed by medical records and/or verbal confirmation from patients. However, Inclusion criteria 6 \& 7 must be verified by a previous PFT report dated within 6 months of screening
Contacts
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