A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

PHASE4TerminatedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
Cystic Fibrosis
Interventions
DRUG

Dornase alfa

2.5 mg inhalation dose twice daily for 14±2 days

DRUG

placebo

2.5 mg inhalation dose twice daily for 14±2 days

Trial Locations (40)

11040

Long Island Jew Adult CF Ctr, New Hyde Park

12208

Albany Medical College, Albany

13210

SUNY Upstate Medical Univ, Syracuse

15260

University of Pittsburgh, Pittsburgh

26506

W Virginia Univ Health Sci Ctr, Morgantown

27710

Duke Pediatric Clinical, Durham

29203

Pediatric Pulmonary Assoc, Columbia

29425

Medical Univ of South Carolina, Charleston

30322

Brown Univ School of Medicine, Atlanta

30912

Medical College of Georgia, Augusta

32204

Pulm & Critical Care Assoc, Jacksonville

32803

Central Florida Pulmonary Grou, Orlando

33136

Univ of Miami, Miami

35233

University of Alabama, Birmingham

40536

Univ of Kentucky Med Ctr, Lexington

43606

Toledo Childrens Hospital, Toledo

44106

Rainbow Babies & Child Hosp, Cleveland

48201

Wayne State University, Detroit

49008

Michigan State University, Kalamazoo

49503

Spectrum Hospital, Grand Rapids

55455

Univ of Minnesota Dept of Derm, Minneapolis

60612

Rush Medical Center, Chicago

63110

Pulmonary & Critical Care Med, St Louis

73112

Santiago Reyes MD-Private Prac, Oklahoma City

74145

CF Solutions, Inc, Tulsa

77030

Baylor College of Medicine, Houston

78212

Alamo Clinical Research Assoc, San Antonio

80206

Nat'l Jewish Med/Research Ctr, Denver

89107

Children's Lung Specialist, Las Vegas

90027

Childrens Hospital of LA, Los Angeles

90033

USC Adult CF Center, Los Angeles

92868

CHOC, Orange

93003

Ventura County Medical Ctr, Ventura

95819

Capital Allergy Resp Dis Ctr, Sacramento

48109-5212

Univ of Michigan Hlth System, Ann Arbor

39216-4505

University of Mississippi, Jackson

07740

Monmouth Medical Center, Long Branch

07962

Morristown Memorial Hospital, Morristown

08901

St. Peters Univ Hospital, New Brunswick

87131-0001

University of New Mexico, Albuquerque

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY