N/A
N=7
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
COPD Exacerbation
Bottom Line
View on ClinicalTrials.gov: NCT02291016 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: The Difference Between the Values of Area Under the Response Curve for FEV1 — 203.0; 185.0 mcg*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Formoterol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Tennessee Graduate School of Medicine
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference Between the Values of Area Under the Response Curve for FEV1 |
203.0; 185.0 | — |
| SECONDARY Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol |
28.2; 21.1 | — |
| SECONDARY Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol |
12.2; 9.5 | — |
| SECONDARY Peak FEV1 Between the Two Devices (Nebulizer and DPI) |
12.2; 9.5 | — |
| SECONDARY Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol |
21.5; 18.4 | — |
| SECONDARY Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol |
327.0; 293.4 | — |
| SECONDARY Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol |
22.1; 18.2 | — |
| SECONDARY Peak FVC Between the Two Devices (Nebulizer and DPI) |
86.7; 82.0 | — |
| SECONDARY Change in Dyspnea Based on the Borg Dyspnea Scale for Shortness of Breath (Pre-dose Administration and 60 Minutes After Inhalation of Formoterol With a Nebulizer or a DPI) |
-0.59; 0 | — |
Summary
The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.
Eligibility Criteria
Inclusion Criteria
- Current or past cigarette smoking history of >/= 10 pack-years.
- FEV1/FVC ratio 450 ms).
- Liver cirrhosis or chronic renal insufficiency (serum creatinine > 2 mg/dL).
- Atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia).
- Acute myocardial infarction within 12 weeks of patient study registration.
- Known pulmonary embolism.
- Known or suspected lung cancer.
- Known neuromuscular disease, stroke with residual hemiparesis, or untreated Parkinsonism
- 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 sub dermal implants).
- Inability to understand instructions.
- Participation in another investigational drug clinical trial within 30 days of patient study registration.
Data sourced from ClinicalTrials.gov (NCT02291016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.