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Summary: A study for males and females 18 through 70 years
old with mild or moderate asthma.
The purpose of this study is to evaluate an oral investigational
treatment for subjects with stable asthma. This study is open
to male and female subjects 18 to 70 years old. Study participants
will have 11 visits to a research center over approximately 30
weeks. Patients will be withdrawn from their current controller
medication and enter a run-in phase. After completion of the run-in
phase, patients will receive the investigational drug at 250 mcg
or 500 mcg, or placebo.
All study-related medication, doctor visits and breathing tests
will be provided. Study participants will be asked to complete
a daily electronic diary to record their use of study medication
and their asthma symptoms.
Patient Inclusion Criteria
Patients with the following may be eligible for the study.
· Men and women aged 18 through 70 years of age.
· The patient has received verbal and written study information.
· The patient has a diagnosis of persistent bronchial asthma.
· There has been no change in asthma treatment within 4
weeks prior to Visit 1.
· Patient is a non-smoker or ex-smoker (for 12 months or
longer.)
· In the investigators judgment, the patient is able and
willing to comply with study visits and procedures (including
laboratory tests, lung function tests), plus accurate and timely
completion of an electronic daily study diary.
Patient Exclusion Criteria
Patients with the following are not eligible for the study.
· Patients with poorly controlled asthma or exacerbation
of asthma in the four weeks prior to Visit 1 (in the investigator's
judgment).
· Patients who suffer from seasonal asthma alone.
· A history of lower airway infection in the four weeks
prior to Visit 1.
· A diagnosis of chronic obstructive pulmonary disease
(COPD) and/or other relevant lung disease.
· Abnormal laboratory values suggesting an undiagnosed
disease, severe renal insufficiency, active hepatitis, or an HIV
infection.
· A diagnosis, treatment or remission of any cancer (other
than basal cell carcinoma) within two years prior to Visit 1.
· Patients with chronic heart failure.
· Suspected hypersensitivity and/or contraindication to
the study medication or albuterol/salbutamol.
· Females who are pregnant or breast-feeding. Women of
childbearing potential must practice adequate methods of birth
control to prevent pregnancy during the study.
· Patients who have received any investigational medication
or device in the month prior to Visit 1 or who plan to use another
investigational medication during the study. Re-entry of a patient
previously enrolled into the double blind portion of this trial
(i.e., having passed Visit 3 and subsequently withdrawn).
· Patients, who have any other severe or acute or chronic
medical or psychiatric conditions in the judgment of the investigator,
would make the patient inappropriate for entry into this study.
· Spirometry results outside of the limits set by the study
This clinical trial is being done in many areas.
Contacts for some areas are:
Eliana Mendes, Study Coordinator
University of Miami School of Medicine
Room 7064-A
1600 Northwest 10th Avenue
Miami, FL 33101
Telephone: 305-243-2568
Fax: 305-243-6992
Barbara J Bahl, PhD, Study Coordinator
South Hills Pulmonary Associates, Inc.
Suite 306
1050 Bower Hill Road
Pittsburgh, PA 15243
Telephone: 412-942-0010; 412-572-6168
Fax: 412-344-6304
Jamie Plocky, Study Coordinator Brenda Melton, Study Coordinator
UCLA, David Geffen School of Medicine Mississippi Asthma and Allergy
Clinic, PA
CHS32-79 Suites 201 and 101
10833 Le Conte Avenue 1600 North State Street
Los Angeles, CA 90095 Jackson, MS 39202
Telephone: 310-825-3806 Telephone: 601-354-4836
Fax: 310-206-5088 Fax: 601-354-4530
Brenda Melton, Study Coordinator
Mississippi Asthma and Allergy Clinic, PA
Suites 201 and 101
1600 North State Street
Jackson, MS 39202
Telephone: 601-354-4836
Fax: 601-354-4530
Summary: Asthma Research Study
Inclusion Criteria for Asthma Study:
· Non-smoking males and females between 12-75 years of
age
· Diagnosis of asthma
· No change in asthma treatment for the last 4 weeks
· Good general health
· Study consists of 3 visits
· Investigation medication, study related lab tests, EKG
and physical examinations included
· Reimbursement for time and travel
To see if you qualify, call or email The Clinical Research Center.
Contact:
The Clinical Research Center, LLC
1040 N. Mason Road, Suite 112
St. Louis, MO 63141
Telephone: 314-514-8509 or 888-343-1990
Email: recruitment@clinicalresearchcenter.com
Summary: Asthma- Safety of Oral Roflumilast
Mount Sinai School of Medicine is recruiting subjects to participate
in an investigational study for a treatment for asthma.
You may participate in this study if you:
· Are 18 to 70 years old
· Have a diagnosis of asthma
· Are a non-smoker or ex-smoker (for 12 months or longer)
You may not participate in this study if you:
· Have poorly controlled asthma
· Suffer from seasonal asthma
· Have a diagnosis of COPD (chronic obstructive pulmonary
disease)
· Have a history of HIV infection, active hepatitis or
severe renal insufficiency
· Have a diagnosis, treatment or remission of any cancer
· Have chronic heart failure
Contact:
Katherine Barboza, Research Coordinator
Biomedical Research Alliance of New York
Mount Sinai School of Medicine
One Gustave L. Levy Place
New York, NY 10029
Telephone: 212-241-7521
Fax: 212-831-3560
Email: katherine.barboza@mssm.edu
Summary: Is Asthma taking your breath away?
If you are still symptomatic on your current medication, you may
qualify for a research study evaluating an investigational medication
for the treatment of asthma.
You will receive free:
· Study related medical care
· Lung function studies
· Laboratory work-up
· Electrocardiogram
· Study medication
· Compensation
Call now for more information if you of someone you know meet
the following criteria:
· Between the ages of 12 to 75
· Except for asthma in good health
· Medical conditions must be stable
· Non-smoker for at least 1 full year
· Females on reliable method of birth control
· Medical records must be obtainable
Contact:
Commonwealth Clinical Research Specialists
2010 Bremo Road, S-115
Richmond, VA 23226
Telephone: 804-288-7425
Email: ccrs@richmondallergy.com
Summary: Adolescent/Adult Asthma Study.
Eligibility Criteria:
· Ages 12 and Up.
· Must have a 6-month history of Asthma prior to visit
1.
· FEV1 60-85% with 12% reversibility.
· Must be on stable regimen of daily ICS for at least 30
days prior to visit 1.
This is a device study using the new "Easy Breath" breath
actuated device versus current HFA propelled device. Study lasts
12 weeks.
For more information, contact:
Patti Hall, RN, BSN, CCRC,
Director of Clinical Research
Family Allergy and Asthma Research Institute
Bluegrass Avenue Medical Plaza
1700 Bluegrass Avenue, Suite 400
Louisville, KY 40215
Telephone: 502-368-0732
Fax: 502-363-1165
Email: phall@familyallergy.com
Summary: A study for subjects ages 12 years and older with
asthma.
The purpose of this research study is to evaluate an investigational
treatment for subjects with asthma. The study is being done in
the US and is open to male and female subjects ages 12 years and
older. Study participants will have 10 visits to a research center
over approximately 1 year.
Inclusion Criteria:
· Diagnosis of asthma for at least 6 months.
· Subject is in good health with the exception of their
asthma and does not have any chronic condition that may interfere
with their respiratory function.
Exclusion Criteria:
· No clinically significant medical conditions or abnormalities.
· Pregnant women or women who are currently breast-feeding.
· Schedule will not allow subject to start study visits
or take study medication before 10am.
Contact:
Traci Wesson
Heartland Clinical Research Inc
2219 N 91 Plaza
Omaha, NE 68134
Telephone: 402-502-9364
Summary: Asthma Study in San Francisco Now Enrolling.
The purpose of the study is to determine the safety and effectiveness
of an investigational drug in treating asthma. The investigational
drug is a combination of two FDA-approved drugs for the treatment
of asthma.
Dean L. Rider, M.D. will conduct the study. Dr. Rider had been
practicing gastroenterology in San Francisco for over twenty years.
You may be qualified to participate in the study if you:
· Are at least 18 years old.
· Reside in or around San Francisco.
· Have experienced stable mild-to-moderate asthma for over
6 months.
· Required asthma medication during prior 4 weeks.
Study Profile:
· 5 visits to physicians office over 12 weeks.
· Office visits will be conducted at 350 Parnassus Avenue
in San Francisco near UCSF Medical Center.
· There is no charge for study visits, medications, tests
or procedures.
· You will receive all study-related medications, exams
and lab tests at no cost.
· You will receive reimbursement for your time and travel.
If you would like to learn more about this study, contact:
Julia Beal, Study Coordinator
First Clinical Research
350 Parnassus Ave., Suite 900
San Francisco, CA 94117
Telephone: 415-682-2431
Email: jbeal@firstclinical.com
To find clinical trials in your area, go to: http://www.centerwatch.com/search.asp
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