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

NCT02291016 | Completed Results

• 1 other identifier: 3798
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD Exacerbation

Keywords

COPD; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• The Difference Between the Values of Area Under the Response Curve for FEV1

  The difference between the values of area under the response curve for FEV1 from baseline through four hours (AUC FEV1 0-4h) after inhalation of formoterol with a nebulizer or a dry powder inhaler.

  Baseline through study completion (visit 1 through visit 2)

Secondary Outcomes (8)

• Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol

  From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2

• Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol

  Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed

• Peak FEV1 Between the Two Devices (Nebulizer and DPI)

  Measured from Start of visit 1 until the completion of visit 2

• Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol

  Baseline through study completion (visit 1 through visit 2)

• Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol

  Measured at visit 1 and again at the end of visit 2

Study Arms (2)

Formoterol via DPI then Formoterol via nebulizer

ACTIVE COMPARATOR

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.

Drug: Formoterol; Other: Placebo

Formoterol via nebulizer then Formoterol via DPI

ACTIVE COMPARATOR

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.

Drug: Formoterol; Other: Placebo

Interventions

Formoterol DRUG

Comparison of dosage administered via a nebulizer versus dosage administered via a dry powder inhaler. 12 µg Formoterol with the dry powder inhaler and 20 µg (solution form) of Formoterol with the nebulizer. Patients will receive formoterol and placebo at both study visit #1 and visit #2.

Also known as: Foradil, PERFOROMIST

Formoterol via DPI then Formoterol via nebulizer; Formoterol via nebulizer then Formoterol via DPI

Placebo OTHER

Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer 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.

Also known as: Normal Saline

Formoterol via DPI then Formoterol via nebulizer; Formoterol via nebulizer then Formoterol via DPI

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Mylan Specialty L.P.: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trials Coordinator
• Organization: University of Tennessee Graduate School of Medicine

jferris@utmck.edu

865-305-7975

Study Officials

• Rajiv Dhand, MD

  University of Tennessee Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 14, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Locations

US (1)