AsthmaPhase 1NCT01621386

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

A Phase 1 study testing Montelukast and Prednisone in people with Asthma, run by Hal C Charles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Montelukast and Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Mar 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is a male or female 18 to 65 years of age with clinical diagnosis of asthma for at least 1 year at the prestudy (screening) visit.
For female patients of reproductive potential, a blood pregnancy test will be performed, and it must be negative before the patient can continue in this study. If sexually active, the patient must agree to use appropriate contraceptive measures for the duration of the study and for 2 weeks after Visit 5. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
Patient understands the study procedures and agrees to participate in the study by giving written informed consent (Consent must be given before any study procedures are performed)
Patient is willing to comply with the study restrictions and adhere to the visit/protocol schedules.
Patient is judged to be in good health (except for asthma) based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug and has no evidence of cardiac, endocrine, or metabolic disease.
Patient has a Body Mass Index (BMI) ≤ 39 kg/m2 at the prestudy screening (Visit 1). BMI is calculated by taking the patient's weight in kg and dividing by the patient's height in meters, squared. Patient's body must fit within the scanner sufficiently well to allow satisfactory imaging in the opinion of the investigator.

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Patient is a current non-smoker or if patient has a history of smoking, has not smoked for at least 6 months and has a smoking history of no more than 5 pack-years (i.e., 1 pack per day for 5 years). Patients who have discontinued smoking or the use of nicotine / nicotine containing products for at least approximately 3 months may be enrolled in the study at the discretion of the investigator.
Patient has been defined by the study site team as having allergic asthma.
Patient is able to perform reproducible pulmonary function testing (i.e., the 2 best acceptable spirograms have FEV1 values that do not vary by more than 5% of the largest value or more than 100 mL, whichever is greater).
Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug.
Patient has no contraindication to MRI exam.
Additional Inclusion Criteria- Mild Asthma
Known diagnosis of asthma for at least one year as defined by NHLBI NAEPP guidelines. (http://www.nhlbi.nih.gov/guidelines/asthma/execsumm.pdf).
FEV1 > 80% predicted
Either reversibility of airflow obstruction after 4 puffs inhaled albuterol of 12% in either the FEV1 or FVC, or hyperresponsiveness by methacholine with PC20 FEV1 < 16 mg/ml.
Asthma Control Questionnaire score < 1.25 consistent with good control
Additional Inclusion Criteria- Moderate and Severe Asthma
Known diagnosis of asthma for at least one year as defined by NHLBI NAEPP guidelines. (http://www.nhlbi.nih.gov/guidelines/asthma/execsumm.pdf).
MODERATE:
Symptoms consistent with moderate asthma as defined by 2007 NAEPP guidelines.
Treatment with low to medium dose ICS +/- a second controller (long acting beta agonist but not leukotriene antagonist).
Spirometry consistent with moderate asthma as defined by NHLBI NAEPP guidelines and evidence of either reversibility of airflow obstruction after 4 puffs inhaled albuterol of 12% in either the FEV1 or FVC, or hyperresponsiveness by methacholine with PC20 FEV1 < 16 mg/ml.
SEVERE:
Treatment with high dose inhaled corticosteroids equivalent to fluticasone > 880 μg/day or beclomethasone > 1260 μg/day.
Two of the Following:
Requirement for daily controller therapy in addition to inhaled corticosteroids including long acting beta agonist but not leukotriene antagonist
Symptoms requiring short acting beta agonist use daily
Persistent airway obstruction (FEV1 < 80%, peak expiratory flow variability > 20%)
One or more urgent care visits for asthma per year
Three or more "bursts" of oral corticosteroids per year
Prompt deterioration with greater than 25% reduction in inhaled or oral corticosteroid dose
Note: near fatal asthma event in the past is part of the definition, but subjects will not be eligible for study if they fulfill this criterion within the past 5 years.

Who cannot join

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.

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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.
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.
Patient has unresolved signs and/or symptoms of an upper respiratory tract infection or has had antibiotics administered within 4 weeks of Visit 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients

Conditions: Asthma
Being tested: Montelukast, Prednisone
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MontelukastDrug
Also called Singulair
Administered orally as a single daily 10 mg dose for 2 weeks
PrednisoneDrug
Administered orally as a single daily 20 mg dose for 2 weeks

Study groups in NCT01621386
Study group	Role	What they receive
All Participants	Experimental	Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2) Receives: Drug: Montelukast; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment
Measured: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by 19F-perfluoropropane MRI (19F MRI) after two weeks of montelukast or prednisone treatment
Measured: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Lung Clearance Index (LCI) after two weeks of montelukast or prednisone treatment
Measured: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Conducting Airway Heterogeneity (Scond) after two weeks of montelukast or prednisone treatment
Measured: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Forced Expiratory Volume in 1 second (FEV1) after two weeks of montelukast or prednisone treatment
Measured: Baseline and after two weeks of drug treatment

Secondary outcomes (3)

Comparison of VH assessed by Oe 1H MRI, 19F MRI, LCI, Scond and FEV1 at baseline
Measured: Baseline
Short-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI
Measured: Visit 2 and Visit 3
Mid-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI
Measured: Visit 3 and Visit 4/Visit 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Mar 2016

First posted18 Jun 2012 (estimated)
Study startJan 2013
Primary completionSep 2015
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01621386
Sponsor's protocol ID: Pro00038169
Other IDs: MK-0476-513
Status last verified: Apr 2017
First submitted: 14 Jun 2012
Last updated: 20 Apr 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients
ClinicalTrials.gov ID: NCT01621386
Acronym / sponsor ID: Pro00038169
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Hal C CharlesUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Jan 2013
Primary completion: Sep 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 18 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Participants	Experimental	Drug: Montelukast, Drug: PrednisoneParticipants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (32 listed)

Patient is a male or female 18 to 65 years of age with clinical diagnosis of asthma for at least 1 year at the prestudy (screening) visit.
For female patients of reproductive potential, a blood pregnancy test will be performed, and it must be negative before the patient can continue in this study. If sexually active, the patient must agree to use appropriate contraceptive measures for the duration of the study and for 2 weeks after Visit 5. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
Patient understands the study procedures and agrees to participate in the study by giving written informed consent (Consent must be given before any study procedures are performed)
Patient is willing to comply with the study restrictions and adhere to the visit/protocol schedules.
Patient is judged to be in good health (except for asthma) based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug and has no evidence of cardiac, endocrine, or metabolic disease.

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MontelukastAlso: SingulairAdministered orally as a single daily 10 mg dose for 2 weeks	Drug	All Participants
PrednisoneAdministered orally as a single daily 20 mg dose for 2 weeks	Drug	All Participants

Primary outcome

Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment
Time frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by 19F-perfluoropropane MRI (19F MRI) after two weeks of montelukast or prednisone treatment
Time frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Lung Clearance Index (LCI) after two weeks of montelukast or prednisone treatment
Time frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Conducting Airway Heterogeneity (Scond) after two weeks of montelukast or prednisone treatment
Time frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Forced Expiratory Volume in 1 second (FEV1) after two weeks of montelukast or prednisone treatment
Time frame: Baseline and after two weeks of drug treatment

3 secondary outcomes

Comparison of VH assessed by Oe 1H MRI, 19F MRI, LCI, Scond and FEV1 at baseline
Time frame: Baseline
Short-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI
Time frame: Visit 2 and Visit 3
Mid-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI
Time frame: Visit 3 and Visit 4/Visit 5

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cecil Charles, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Montelukast and Prednisone in people with Asthma, run by Hal C Charles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment (time frame: Baseline and after two weeks of drug treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01621386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.