COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers

University of Tennessee Graduate School of Medicine

Status: Completed

Conditions: COPD Exacerbation

Treatments: Drug: Formoterol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02291016

3798

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current or past cigarette smoking history of >/= 10 pack-years.
• FEV1/FVC ratio </= 70%.
• Known diagnosis of COPD.
• Current hospitalization for a primary diagnosis of acute exacerbation of COPD.
• Must be able to understand and willing to sign an informed consent document.

Exclusion criteria

• On a ventilator or mask ventilation.
• Allergy or contraindication to Formoterol use.
• Marked QTc prolongation (> 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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7 participants in 2 patient groups

Formoterol via DPI then Formoterol via nebulizer

Active Comparator group

Description:

Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2. Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.

Treatment:

Other: Placebo

Drug: Formoterol

Formoterol via nebulizer then Formoterol via DPI

Active Comparator group

Description:

Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2. Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.

Treatment:

Other: Placebo

Drug: Formoterol