Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Assessment of Arformoterol for COPD Using Hyperpolarized 3He MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846287
• Other study ID #: Docket # 12830
• Status: Completed
• Phase: N/A
• First received: February 16, 2009
• Last updated: October 3, 2012
• Start date: November 2008
• Est. completion date: April 2011

Study information

• Verified date: October 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine efficacy of MR imaging with hyperpolarized helium-3 gas in COPD patients both before and after treatment.

Description:

Hyperpolarized Helium Lung imaging has already been tested and proven to be scientifically possible in patients with a number of pulmonary disorders. However there is limited data on the sensitivity of this imaging technique, which would be essential for clinical use. This study is a double blinded study with two cohorts, each cohort being made up of patients with confirmed diagnosis of COPD. One group will receive a placebo while the other will receive treatment. A comparison of the data will resume once twenty patients have been consented and completed the study procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Are male or female and are 50 years or older

• Consent from the patient

• Have been diagnosed with COPD

• Must be able to hold their breath for up to 12 seconds

• Must have a baseline FEV1 = 80% of predicted but FEV1 > 0.70 L

• Must have a smoking history of 15 or more packs per year

• Must have a breathlessness severity of = 2 on the Medical Research Council dyspnea scale

• Must be able to safely discontinue their respiratory medications for at least 12 hours.

Exclusion Criteria:

• Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field

• Are undergoing the MR exam in an emergency situation

• Are pregnant or become pregnant at any point within the study time.

• People with psychiatric disorders will be excluded from the study.

• Are claustrophobic and can not tolerate the imaging.

• Uses supplemental oxygen

• Have life-threatening or unstable respiratory status within 30 days before screening

• Have a diagnosis of asthma and/or any chronic respiratory disease other than COPD

• Have a lung resection greater than 1 full lobe

• Have coronary artery disease or congestive heart failure

• Are allergic to Arformoterol or similarly related drugs.

• Are taking any of the drugs listed in the risks section and are unable to stop taking them.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the intervention (drug or placebo) will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.
• Placebo
Subject will inhale a placebo (nebulized saline) with no drug.
• Aformoterol
Subjects will receive the drug arformoterol prior to scanning

Locations

Country	Name	City	State
United States	UMASS Medical School Advanced MRI Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Ventilation Volume	Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described: The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation.	2 hours	No
Secondary	Change in FEV1	Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.	2 hours	No