Standardized Treatment of Pulmonary Exacerbations II



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:12/15/2018
Start Date:June 2016
End Date:February 2020
Contact:Barbra Fogarty
Email:barbra.fogarty@seattlechildrens.org
Phone:206-884-7592

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Standardized Treatment of Pulmonary Exacerbations II (STOP2)

Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during
which symptoms of lung infection increase and lung function decreases. These pulmonary
exacerbations are treated with varying antibiotics for varying time periods based on needs
determined by individual patients, their families, and the health care providers. Cystic
fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the
Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also
identified key questions for which additional studies were needed.

A strong desire among clinicians to reduce treatment durations (and reduce cost,
inconvenience, and potential toxicities) is in conflict with belief that patients not
responding robustly to treatment might benefit from extending treatment.

This randomized, controlled, open-label study is designed to evaluate the efficacy and safety
of differing durations of IV treatment, given in the hospital or at home for a pulmonary
exacerbation in adult patients with CF.

The study will assess the non-inferiority of 10 days versus 14 days treatment duration among
patients who have an early robust improvement (ERR subjects) and the superiority of 21 days
versus 14 days treatment duration among the subjects who do not meet the definition of ERR
(non-ERR; NERR).

Subjects will undergo pulmonary function testing (spirometry) and complete a respiratory
symptom score [Chronic Respiratory Infection Symptom Score (CRISS)] at initiation of IV
treatment (Baseline/ Visit 1) and at Day 7-10 (Visit 2). At Visit 2, subjects will be
allocated to groups ERR or NERR based on their initial clinical response as determined by the
change in forced expiratory volume in 1 second (FEV1; percent of predicted) and CRISS from
Baseline and then randomized to an IV treatment duration (nested within group).

ERR subjects [≥8% predicted improvement in FEV1 from Visit 1 to Visit 2 and CRISS reduction
of ≥11 points from Visit 1 to Visit 2] will be randomized 1:1 to either 10 days or 14 days
total IV antibiotic treatment duration. Remaining (NERR) subjects will be randomized 1:1 to
receive either 14 or 21 days total IV antibiotic treatment duration. All subjects will be
evaluated again at Visit 3, 14 days following scheduled completion of IV antibiotic
treatment.

Inclusion Criteria:

Key Inclusion Criteria:

- Male or female ≥18 years of age at Visit 1

- Documentation of a CF diagnosis

- Enrolled in the Cystic Fibrosis Foundation National Patient Registry (CFFNPR) prior to
Visit 1 (US sites only)

- At the time of Visit 1, there is a plan to initiate IV antibiotics for a pulmonary
exacerbation

- Performed spirometry at Visit 1 and Visit 2 and willing to perform spirometry at Visit
3

- Completed the CRISS questionnaire at Visit 1 and Visit 2 and willing to complete the
Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) questionnaire at Visit 3

- Willing to adhere to a specific treatment duration determined by initial response to
treatment and subsequent randomization

- Willing to return for follow up Visit 3

- Written informed consent obtained from the subject or subject's legal representative

Exclusion Criteria:

Key Exclusion Criteria

- Previous randomization in this study

- Treatment with IV antibiotics in the 6 weeks prior to Visit 1

- Admission to the intensive care unit for current pulmonary exacerbation in the two
weeks prior to Visit 2, unless admission was due to a desensitization protocol

- Pneumothorax in the two weeks prior to Visit 2

- Primary diagnosis for current hospitalization is unrelated to worsening lower
respiratory symptoms (e.g., pulmonary clean out, distal intestinal obstruction
syndrome (DIOS), sinusitis)

- Massive hemoptysis defined as > 250 cc in a 24 hour period or 100 cc/day over 4
consecutive days occurring in the two weeks prior to Visit 2

- Current pulmonary exacerbation thought to be due to allergic bronchopulmonary
aspergillosis (ABPA)

- At Visit 1, receiving ongoing treatment with a duration of more than 2 weeks with
prednisone equivalent to >10mg/day

- History of solid organ transplantation

- Receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M.
abscessus, M. avium complex) in the two weeks prior to Visit 2
We found this trial at
58
sites
1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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Anchorage, Alaska 99508
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Augusta, Georgia 30912
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Baltimore, Maryland 21287
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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300 Longwood Avenue
Boston, Massachusetts 02115
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Burlington, Vermont 05405
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3330 Hospital Drive Northwest
Calgary, Alberta T2N 4N1
Phone: 403-220-5951
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Chapel Hill, North Carolina 27599
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Cleveland, Ohio 44106
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Dallas, Texas 75390
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Dayton, Ohio 45404
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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3990 John R Street
Detroit, Michigan 48201
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Gainesville, Florida 32610
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
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Houston, Texas 77030
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Kansas City, Kansas 66160
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La Jolla, California 92093
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Long Branch, New Jersey
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Madison, Wisconsin 53792
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Milwaukee, Wisconsin 53226
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Morgantown, West Virginia 26506
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Morristown, New Jersey 07962
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120 Albany Street
New Brunswick, New Jersey 08903
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Palo Alto, California 94394
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Peoria, Illinois 61637
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401 North 11th Street
Richmond, Virginia 23298
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601 Elmwood Avenue
Rochester, New York 14642
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3635 Vista at Grand Ave.
Saint Louis, Missouri 63110
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1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Tucson, Arizona 85721
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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55 North Lake Avenue
Worcester, Massachusetts 01655
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