- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291016
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
A Randomized, Double-Dummy, Crossover, Single-Center Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers in the Treatment of Patients Recovering From Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Formoterol via DPI then Formoterol via nebulizer
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. |
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.
Other Names:
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.
Other Names:
|
Active Comparator: Formoterol via nebulizer then Formoterol via DPI
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. |
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Difference Between the Values of Area Under the Response Curve for FEV1
Time Frame: Baseline through study completion (visit 1 through visit 2)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol
Time Frame: 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
|
Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2. Steps:
|
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
Time Frame: Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed
|
Increase in FEV1 from Baseline to 4 hours post dose of formoterol. This will be completed at visit 1 and visit 2. Steps:
|
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)
Time Frame: Measured from Start of visit 1 until the completion of visit 2
|
Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2. Steps:
5. Peak measurements from visit 1 and visit 2 will be compared for any significant change in FEV1 values. |
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
Time Frame: Baseline through study completion (visit 1 through visit 2)
|
Change in FEV1 from Baseline through 4 hours post formoterol dose. This was completed at visit 1 and visit 2. Steps:
|
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
Time Frame: Measured at visit 1 and again at the end of visit 2
|
Steps:
Data was all time points were used to obtain the total area under the curve |
Measured at visit 1 and again at the end of visit 2
|
Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol
Time Frame: Measured at visit 1 and again at the end of visit 2
|
|
Measured at visit 1 and again at the end of visit 2
|
Peak FVC Between the Two Devices (Nebulizer and DPI)
Time Frame: Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.
|
Steps:
|
Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.
|
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)
Time Frame: Measured at visit 1 and again at the end of visit 2
|
The Shortness of Breath Modified Borg Dyspnea Scale The scale goes from 0-10, zero meaning no difficulty breathing and ten meaning maximal difficulty.
A decrease of score indicates an improvement.
Patients were asked to complete the scale pre-dose and again one hour post formoterol dose.
This was completed at both visit 1 and visit 2. The value recorded was the difference between the baseline value and the post 60 minute value.
|
Measured at visit 1 and again at the end of visit 2
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rajiv Dhand, MD, University of Tennessee Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- 3798
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD Exacerbation
-
University Medical Center GroningenCompleted
-
Sociedad Española de Neumología y Cirugía TorácicaGlaxoSmithKlineNot yet recruitingCOPD Exacerbation
-
University of Tennessee Graduate School of MedicineMylan Pharmaceuticals IncRecruiting
-
Malcolm KohlerDeep Breath Intelligence (DBI)RecruitingCOPD ExacerbationSwitzerland
-
Universidad Autonoma de MadridCompleted
-
Guy's and St Thomas' NHS Foundation TrustCompleted
-
Hospital Universitario Marqués de ValdecillaGlaxoSmithKlineUnknown
-
Hospital Universitario Marqués de ValdecillaRecruiting
-
Ottawa Hospital Research InstituteCompleted
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)CompletedCOPD ExacerbationUnited States
Clinical Trials on Formoterol
-
AstraZenecaParexelCompletedChronic Obstructive Pulmonary Disease - COPDUnited States
-
Mundipharma Research LimitedCompletedAsthmaUnited Kingdom
-
AstraZenecaTerminatedPulmonary Disease, Chronic ObstructiveUnited States
-
University of California, Los AngelesDey, L.P.WithdrawnChronic Obstructive Pulmonary Disease | Emphysema | COPD | Chronic BronchitisUnited States
-
AstraZenecaCompletedChronic Obstructive Pulmonary DiseaseUnited States, Peru, South Africa, Argentina, Mexico, Brazil, Chile, Colombia, Venezuela
-
AstraZenecaCompletedChronic Obstructive Pulmonary DiseaseUnited States
-
AstraZenecaCompletedChronic Obstructive Pulmonary DiseaseRomania, Czech Republic
-
Palo Alto Veterans Institute for ResearchAlzheimer's Association; Mylan Inc.WithdrawnCognitive Dysfunction | Alzheimer's DiseaseUnited States
-
SkyePharma AGCompleted
-
Orion Corporation, Orion PharmaCompleted