Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
Differentiating the Effects of Long-acting Bronchodilators Administered by Nebulizer Versus Dry Powder Inhaler in Symptomatic Patients With Chronic Obstructive Pulmonary Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
- Procedures mentioned: Questionnaires, Physical exams, Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer"
- "They will be trained on the use of the DPI and nebulizer, as well as completion of the daily diary (symptom and medication logs) and questionnaires (CAT, BDI/TDI, SGRQ)."
- "Vital signs and a physical examination will be performed, and inspiratory flow rate will be determined using the In-Check DIAL."
- "Participants complete CAT, BDI, and SGRQ questionnaires, undergo physical examination and vital sign measurement, and perform baseline pulmonary function testing in a plethysmograph."
- "Participants also receive training on diary use, study drug/device administration, and medication compliance, and they begin the assigned treatment for 12 weeks with morning and evening doses as per group assignment."
- "Following Visit 2, patients will continue their assigned treatments twice daily for 12 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two ways to take long-acting medicines that open the airways: a nebulizer, which makes a mist, and a dry powder inhaler. It is for adults over 40 with COPD, a lung disease that makes breathing hard, who have symptoms and trapped air in their lungs. The study tests which method reduces trapped air and symptoms more.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be over 40 years old. Any sex may join.
- Smoke now, or have smoked more than 10 pack-years in the past. One pack-year means smoking one pack a day for one year.
- Have COPD symptoms, such as cough, mucus, or shortness of breath.
- Have a breathlessness score (mMRC) of at least 2 or a COPD symptom score (CAT) of at least 10 at the screening/run-in visit.
- Have a peak breathing-in flow (PIFR) above 30 at screening.
- Have a breathing test ratio called FEV1/FVC below 70%. The listing says this test and PIFR must be confirmed by a lung test report from within 6 months of screening.
- Have trapped air left after breathing out (residual volume) at least 120% of the expected amount, measured within the past 12 months.
Who can't join
- Have asthma, or have had a COPD flare-up within 8 weeks.
- Have a past diagnosis of atrial fibrillation with a heart rate above 110 beats per minute, or ventricular tachycardia—types of abnormal heartbeat. A heart attack within 12 weeks of study registration or a sudden worsening of heart failure also rules you out.
- Have had eye surgery within 8 weeks, or have uncontrolled glaucoma, an eye disease that can damage sight.
- Have cirrhosis, which is liver scarring, or long-term kidney problems with a past blood creatinine level above 2.5 mg/dL.
- Cannot tolerate a study medicine, take azithromycin long-term, or have joined another study testing a drug within 30 days of registration.
- Have surgery planned that requires a hospital stay within 3 months, or are currently in a lung rehabilitation program.
- Cannot give informed consent, understand the instructions, or follow the study plan.
- Are pregnant or breastfeeding, or could become pregnant and are not using medically approved birth control.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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
Study sites (1)
TN
- The University of Tennessee Graduate School of Medicine · Knoxville, TN 37920Tracy Walker, Study Coordinator · Study contact · 865-305-4297 · twalker5@utmck.eduRajiv Dhand, MD · Principal investigatorIsaac Biney, MD · Sub-investigatorSamuel Treat, MD · Sub-investigatorMore trials in Knoxville