N/A
N=31
Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00846287 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Change in Total Ventilation Volume — 0.154317; -0.13687 Litres
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyperpolarized Helium-3 (Drug); Placebo (Drug); Aformoterol (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Ventilation Volume |
0.154317; -0.13687 | — |
| SECONDARY Change in FEV1 |
-0.12; 0.16 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00846287). 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.