10 city macrolides in asthma study for mycoplasma & chlamydia recruiting

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© 2007 Dudley & Leslee Dudley. All rights reserved.

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- Double blind asthma study pays patients $1,250.

- Study in 10 cites: San Francisco, San Diego, Denver,

Boston, St. Louis, New York City, Winston Salem, Durham,

Galveston, Madison. (see below for addresses and phone numbers)

- clarithromycin 500 mg. 2 x a day or placebo, plus inhaled steroid

- 11 study visits over 33 weeks, about 9 months

- Visits are for medical check ups, breathing and blood tests

(patients can have copies of blood tests)

- Bronchoscopy for PCR tests of lung tissue to find mycoplasma,

chlamydia or other pathogens.

- 1 blood sample is for a voluntary and anonymous genetics

screening DNA test for identifying genes related to asthma.

- At home patients use a peak flow meter and record results and

symptoms on a dairy card.

- After study is completed and published, patients can have results

of their PCR tests and find out if they were on the drug or placebo.

- Study plans to enroll 224 patients, 144 are currently enrolled.

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ACRN Trial - " MACROLIDES IN ASTHMA " (MIA)

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This study is currently recruiting patients.

Verified by National Heart, Lung and Blood Institute (NHLBI)May 2007

Sponsored by: National Heart, Lung and Blood Institute( NHLBI)

Information provided by: National Heart, Lung and Blood Institute

(NHLBI)

ClinicalTrials.gov Identifier: NCT00318708

http://clinicaltrials.gov/ct/show/NCT00318708;jsessionid=243BF859687BD

DDC3A9A553042FDF59E?order=17

http://clinicaltrials.gov/ct/search?term=asthma

PURPOSE

Asthma can be caused by a variety of factors, including tobacco

smoke, allergens, and respiratory airway infections. Many people use

inhaled corticosteroid medications to treat their symptoms. These

medications, however, are not effective for everyone. Clarithromycin

is an antibiotic that may effectively treat asthma in these

individuals. This study will evaluate the effectiveness of

clarithromycin at controlling asthma symptoms.

Condition - Asthma

Intervention - Drug: Clarithromycin

Phase - Phase III

MedlinePlus related topics: Asthma

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control,

Parallel Assignment, Safety/Efficacy Study

Official Title: Asthma Clinical Research Network (ACRN) Trial -

Macrolides in Asthma (MIA)

Further study details as provided by National Heart, Lung, and Blood

Institute (NHLBI):

Primary Outcome Measures:

Asthma control questionnaire (ACQ) results (measured at Week 16)

Secondary Outcome Measures:

- Asthma symptoms

- Asthma rescue medication use

- AM and PM peak expiratory flow (PEF)

- Forced expiratory volume in one second (FEV1)

- Asthma-specific quality of life

- Methacholine provocative concentration (PC20)

- Exhaled nitric oxide (eNO)

- Blood cell counts

- AM cortisol (all measured at Week 16)

Total Enrollment: 144

Study start: June 2006

Asthma prevalence has steadily increased in the United States since

the early 1980s; currently, more than 20 million people are diagnosed

with asthma. Individuals with this disease may experience periodic

attacks of wheezing, shortness of breath, chest tightness, and

coughing. While there are many known causes of asthma, including

tobacco smoke and other allergens, the exact cause of some asthma

cases remains unknown. Research has shown that in some individuals

respiratory airway infections may play a role in the onset and

severity of the disease. Inhaled corticosteroids are commonly used to

treat asthma; however, they do not effectively control symptoms for

everyone. Clarithromycin, an antibiotic medication used to treat

bacterial infections, may be an effective asthma treatment for

individuals who do not respond well to inhaled corticosteroids. The

purpose of this study is to evaluate the effectiveness of

clarithromycin at reducing asthma symptoms.

This study will begin with a 4-week run-in period to standardize

participants' asthma medication usage. During this time, all

participants will stop their current asthma medications and instead

will receive inhaled fluticasone twice a day. Albuterol will be

available as a rescue medication if necessary. Study visits will take

place every 2 weeks. Blood and saliva samples will be obtained for

laboratory tests and participants will complete standardized

questionnaires to assess asthma symptoms and quality of life.

Spirometry will be performed to measure lung function. Medication

adherence will be monitored with a daily diary and an electronic pill

counting device. At the end of Week 4, participants will be evaluated

for study eligibility. If eligible, participants will undergo a

bronchoscopy and a lung biopsy to test for Mycoplasma pneumoniae and

Chlamydia pneumoniae, two bacteria that have been identified as

possible factors in the development of asthma.

The treatment phase of the study will last 16 weeks. Participants

will be randomly assigned to receive either 500 mg of clarithromycin

or placebo twice a day, plus inhaled fluticasone. At monthly study

visits, spirometry and blood collection will be performed.

Standardized questionnaires to assess asthma symptoms will be

completed every 2 weeks. Medical adherence will continue to be

monitored. At the end of Week 16, participants will stop receiving

clarithromycin or placebo, but will continue to receive fluticasone.

Asthma symptoms, rescue medication usage, quality of life, and lung

capacity will be assessed; tissue samples will be examined for the

presence of Mycoplasma pneumoniae and Chlamydia pneumoniae. An 8-week

washout period will follow to observe any lingering medication

effects and to monitor for safety. Monthly study visits during this

period will include spirometry and blood collection.

ELIGIBILITY

Ages Eligible for Study: 18 Years-60 Years,

Genders Eligible for Study: Both

CRITERIA

INCLUSION CRITERIA:

- History of physician-diagnosed asthma

- Methacholine PC20 less than or equal to 16 mg/ml and/or FEV1

improvement greater than or equal to 12% in response to 180 mcg

albuterol

- Stable asthma for at least 6 weeks prior to study entry

- FEV1 greater than or equal to 60% of predicted result following

180 mcg albuterol

- Juniper ACQ score greater than or equal to 1.5 (optimal ACQ score

cut-off point for asthma that is " not well-controlled " by NIH/Global

Initiative for Asthma [GINA] guidelines)

- Nonsmoker (less than 10 pack-per-year lifetime smoking history

and no smoking in the year prior to study entry)

- Able to perform spirometry, as per American Thoracic Society

criteria

- 75% adherence with diary cards, fluticasone (monitored with

Doser), and placebo pill trial (monitored electronically with

Electronic Drug Exposure Monitor [eDEM] pill dose counter) for the

final 2 weeks of the four-week run-in period

- At Visit 1, in steroid-naïve participants, no significant adrenal

suppression, defined as a plasma cortisol concentration less than 5

mcg/dL. If adrenal suppression occurs, a 250 mcg corticotropin (ACTH)

stimulation test will be performed. - Plasma cortisol levels

will be collected at baseline, and 30 and 60 minutes after the ACTH

stimulation test.

- Participants must have a cortisol concentration greater than 20

mcg/dL

on at least one of the post-ACTH time points

- Absence of bronchoscopy-induced exacerbation; if bronchoscopy-

induced exacerbation has occurred, prednisone therapy must have

stopped at least 6 weeks prior to study entry

- Absence of respiratory tract infection; if infection has occurred,

infection-related symptoms must have stopped at least 6 weeks prior

to study entry

- Has experienced no more than two exacerbations or respiratory

tract infections prior to study entry

- If female and able to conceive, willing to utilize two medically

acceptable forms of contraception (one non-barrier method with single

barrier method OR double barrier method)

EXCLUSION CRITERIA:

- Presence of lung disease other than asthma

- Presence of vocal cord dysfunction, due to potential confounding

of ACQ score

- Significant medical illness other than asthma

- History of atrial or ventricular tachyarrhythmia

- Use of any medication that has a significant interaction with

clarithromycin, including herbal or alternative therapies

- Asthma exacerbation within 6 weeks of the screening visit or

during the run-in period prior to bronchoscopy

- Use of systemic steroids or change in dose of controller therapy

within 6 weeks of the screening visit

- Inability, in the opinion of the study investigator, to

coordinate use of dry powder or metered-dose inhaler or to comply

with medication regimens

- Inability or unwillingness to perform required study procedures

- Prolonged heart rate corrected QT-interval (greater than 450 msec

in women and greater than 430 msec in men) on echocardiogram (ECG) at

study entry

- Low potassium or magnesium levels (based on local Asthma Clinical

Research Network laboratory definitions)

- Abnormal elevation of liver function tests (AST, ALT, total

bilirubin, or alkaline phosphatase)

- Abnormal prothrombin time (PT) or partial thromboplastin time

(PTT) results

- Reduced creatinine clearance

- Contraindication to bronchoscopy, as determined by medical

history or physical examination

- Regular consumption of grapefruit or grapefruit juice

- Pregnant or breastfeeding

LOCATION AND CONTACT INFORMATION

Please refer to this study by ClinicalTrials.gov identifier

NCT00318708

Vernon M Chinchilli, PhD 717-531-4262 vchinchi@...

SAN FRANCISCO, CALIFORNIA

University of California, San Francisco, San Francisco, California,

94143, United States; Recruiting

Homer A Boushey, MD 415-476-8019 homer.boushey@...

Lazarus, MD 415-476-2091 lazma@...

Homer A Boushey, MD, Principal Investigator

SAN DIEGO, CALIFORNIA

University of California, San Diego, San Diego, California, 92093,

United States; Recruiting

I Wasserman, MD 858-822-4261 swasserman@...

Joe Ramsdell, MD 619-543-7241 jramsdell@...

I Wasserman, MD, Principal Investigator

http://216.239.51.104/search?q=cache:An8KbWNWZC8J:ctc.ucsd.edu/MIA%

2520Consent%2520bold.doc+paid+ACR N+Trial+-+MACROLIDES+IN+ASTHMA+(MIA)

+paid & hl=en & ct=clnk & cd=1 & gl=us & ie=UTF-8

DENVER, COLORADO

National Jewish Medical and Research Center, Denver, Colorado,

80206, United States; Recruiting

J , MD 303-398-1545 martinr@...

Stanley J Szefler, MD, PhD 303-270-2189 szeflers@...

J , MD, Principal Investigator

BOSTON, MASSACHUSETTS

Brigham & Women's Hospital, Boston, Massachusetts, 02115, United

States; Recruiting

Elliot Israel, MD 617-732-8110 eisrael@...

Wechsler, MD 617-732-7731 mwechsler@...

Elliot Israel, MD, Principal Investigator

ST. LOUIS, MISSOURI

Washington University, St. Louis, St. Louis, Missouri, 63130,

United States; Recruiting

Castro, MD 314-362-6904 castrom@...

J Walter, MD 314-362-8987 mwalter@...

Castro, MD, Principal Investigator

NEW YORK CITY, NEW YORK

Columbia University Medical Center, New York, New York, 10032,

United States; Recruiting

A DiMango, MD 212-305-0290 ead3@...

A DiMango, MD, Principal Investigator

WINSTON SALEM, NORTH CAROLINA

Wake Forest University Health Sciences, Winston Salem, North

Carolina, 27157, United States; Recruiting

P s, MD, PhD 336-713-7500 sppeters@...

Eugene Bleecker, MD 336-713-7500 ebleeck@...

P s, MD, PhD, Principal Investigator

DURHAM, NORTH CAROLINA

Duke University Medical Center, Durham, North Carolina, 27710,

United States; Recruiting

Kraft, MD 919-479-0719 monica.kraft@...

Kraft, MD, Principal Investigator

GALVESTON, TEXAS

University of Texas Medical Branch, Galveston, Texas, 77555,

United States; Recruiting

J Calhoun, MD 409-772-2436 wjcalhou@...

Bill T Ameredes, PhD 409-772-8104 btamered@...

J Calhoun, MD, Principal Investigator

MADISON, WISCONSIN

University of Wisconsin, Madison, Madison, Wisconsin, 53706,

United States; Recruiting

F Lemanske, MD 608-263-6184 rfl@...

A Sorkness, PharmD 608-262-8237

sorkness@...

F Lemanske, MD, Principal Investigator

STUDY CHAIRS OR PRINCIPAL INVESTIGATORS

- J. Calhoun, MD, Principal Investigator, University of

Texas, Galveston

- Castro, MD, Principal Investigator, Washington University,

St. Louis

- F. Lemanske, MD, Principal Investigator, University of

Wisconsin, Madison

- J. , MD, Principal Investigator, National Jewish

Medical and Research Center

Elliot Israel, MD, Principal Investigator, Brigham and Women's

Hospital

- P. s, MD, PhD, Principal Investigator, Wake Forest

University

- Homer A. Boushey, MD, Principal Investigator, University of

California, San Francsico

- I. Wasserman, MD, Principal Investigator, University of

California, San Diego

- DiMango, MD, Principal Investigator, Columbia University

Medical Center

- Kraft, MD, Principal Investigator, Duke University

Reuben M Cherniack, MD, Study Chair, National Jewish Medical and

Research Center

MORE INFORMATION

Asthma Clinical Research Network web site: http://www.acrn.org/

Study ID Numbers: 377; 5U10 HL074231; 7U10 HL074206; 5U10 HL074208;

5U10 HL074073; 5U10 HL074227; 5U10 HL074225; 5U10 HL074204; 5U10

HL074218; 5U10 HL074212

Last Updated: May 29, 2007

Record first received: April 25, 2006

ClinicalTrials.gov Identifier: NCT00318708

Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 18, 2007

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services,

USA.gov Copyright, Privacy, Accessibility, Freedom of Information Act

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