Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

Completed · Phase 1

Conditions studied: Asthma

In brief

This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory defects that occur due to asthma, determine the sensitivity and specificity of MRI in response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due to asthma therapy.

Key facts

Study ID

NCT01621386

Run by

Hal C Charles

People needed

34

Starts

2013-01-01

Expected to finish

2016-03-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patient is mentally or legally incapacitated, has significant emotional problems at the time of Screening (Visit 1) or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator.
• Patient has taken an investigational product within 4 weeks prior to the prestudy (screening) visit. The 4 week window will be derived from the date of the last dose of study drug in the previous study to the prestudy/screening visit of the current study.
• Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study including, but not limited to, diabetes mellitus, hypertension, osteoporosis, as well as poorly controlled concomitant conditions that include obstructive sleep apnea (OSA), gastroesophageal reflux disease (GERD), and chronic sinusitis/rhinitis.
• Students or employees who are under direct supervision by any of the investigators in this protocol are not eligible to participate.
• Patient has significant or unexplained abnormalities on the physical examination and/or laboratory safety tests at Visit 1.
• Patient has a blood pressure of >150 mm Hg systolic or >95 mm Hg diastolic on >2 measurements done >5 minutes apart at Visit 1 or Visit 2.
• Patient has ECG abnormalities consistent with previous myocardial infarction, hypertrophic cardiomyopathy, ischemic heart disease or conduction system disease.
• Patient has evidence of illness that would require treatment with an excluded medication, could be immediately life threatening (e.g., arrhythmias, congenital heart disease), would pose a restriction on participation or successful completion of the study, or would pose an additional risk to administering montelukast to the patient.
• History of intubation due to asthma within the last five (5) years.
• FEV1 < 45% predicted
• Hospitalization within previous 6 months
• Patient has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 8 weeks prior to the prestudy (screening) visit.
• m. Patient has a history of significant multiple and/or severe allergies to medications used (or potentially used) in this study (including albuterol, montelukast, prednisone, acetaminophen, lidocaine, fentanyl, atropine, and midazolam as well as latex), or has had an anaphylactic reaction or significant intolerability to a marketed or investigational prescription or non-prescription drug or to food.
• Patient has a history of stroke, chronic seizures, or major neurological disorder.
• Patient has a history of neoplastic disease.
• Patient is a female who is ≤8 weeks postpartum or breast feeding an infant.
• Patient is pregnant as determined by initial serum β-HCG obtained at Visit 1, becomes pregnant during the study as determined by urine pregnancy testing during subsequent Visits (#2-5), or intends to become pregnant during the time course of the study.
• Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to: pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures) and/or ear implants.
• Patient is unable to perform breath holding or spirometry maneuvers or to tolerate immobilization within the MRI scanner.
• Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day. Subjects that consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator.
• Patient consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
• Patient is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months.
• There is any concern by the investigator regarding the safe participation of the subject in the study or, for any other reason, the investigator considers the subject inappropriate for participation in the study.
• Patient has taken within 5 weeks of Visit 1 or anticipates a need to take oral corticosteroids during the study period except as administered per protocol.
• During Visits 2-5, there is any concern by the investigator regarding the further safe participation of the subject in the study for any reason including but not limited to history and symptoms suggestive of an impending exacerbation (e.g. a drop or downward trend in PEF from the patients personal best values) and/or noncompliance with instructions or medications.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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