A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
12. mai 2017 oppdatert av: Genentech, Inc.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group).
Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
27
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Alabama
-
Birmingham, Alabama, Forente stater, 35233
- University of Alabama
-
-
California
-
Los Angeles, California, Forente stater, 90027
- Childrens Hospital of LA
-
Los Angeles, California, Forente stater, 90033
- USC Adult CF Center
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Orange, California, Forente stater, 92868
- CHOC
-
Sacramento, California, Forente stater, 95819
- Capital Allergy Resp Dis Ctr
-
Ventura, California, Forente stater, 93003
- Ventura County Medical Ctr
-
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Colorado
-
Denver, Colorado, Forente stater, 80206
- Nat'l Jewish Med/Research Ctr
-
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Florida
-
Jacksonville, Florida, Forente stater, 32204
- Pulm & Critical Care Assoc
-
Miami, Florida, Forente stater, 33136
- Univ of Miami
-
Orlando, Florida, Forente stater, 32803
- Central Florida Pulmonary Grou
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Brown Univ School of Medicine
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Augusta, Georgia, Forente stater, 30912
- Medical College of Georgia
-
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Illinois
-
Chicago, Illinois, Forente stater, 60612
- Rush Medical Center
-
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- Univ of Kentucky Med Ctr
-
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-5212
- Univ of Michigan Hlth System
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Detroit, Michigan, Forente stater, 48201
- Wayne State University
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Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Hospital
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Kalamazoo, Michigan, Forente stater, 49008
- Michigan State University
-
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Minnesota
-
Minneapolis, Minnesota, Forente stater, 55455
- Univ of Minnesota Dept of Derm
-
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Mississippi
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Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi
-
-
Missouri
-
Saint Louis, Missouri, Forente stater, 63110
- Pulmonary & Critical Care Med
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89107
- Children's Lung Specialist
-
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New Jersey
-
Long Branch, New Jersey, Forente stater, 07740
- Monmouth Medical Center
-
Morristown, New Jersey, Forente stater, 07962
- Morristown Memorial Hospital
-
New Brunswick, New Jersey, Forente stater, 08901
- St. Peters Univ Hospital
-
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New Mexico
-
Albuquerque, New Mexico, Forente stater, 87131-0001
- University of New Mexico
-
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New York
-
Albany, New York, Forente stater, 12208
- Albany Medical College
-
New Hyde Park, New York, Forente stater, 11040
- Long Island Jew Adult CF Ctr
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke Pediatric Clinical
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Rainbow Babies & Child Hosp
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Toledo, Ohio, Forente stater, 43606
- Toledo Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73112
- Santiago Reyes MD-Private Prac
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Tulsa, Oklahoma, Forente stater, 74145
- CF Solutions, Inc
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15260
- University of Pittsburgh
-
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical Univ Of South Carolina
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Columbia, South Carolina, Forente stater, 29203
- Pediatric Pulmonary Assoc
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Texas
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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San Antonio, Texas, Forente stater, 78212
- Alamo Clinical Research Assoc
-
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West Virginia
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Morgantown, West Virginia, Forente stater, 26506
- W Virginia Univ Health Sci Ctr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Signed Informed Consent Form and, if applicable, Assent Form
- Age ≥ 14 years old at screening
- Proven diagnosis of CF
- Ability to perform acceptable and reproducible spirometry maneuvers at screening
- FVC ≤ 45% predicted for race, height, age, and sex at screening
- Chronic use of Pulmozyme for at least 3 months in the last year and daily or twice daily use during the 14 days prior to screening
- Stable regimen of chest physiotherapy (CPT) for at least 14 days prior to screening
- Ability to complete the 6-minute walk test at screening
- Ability to complete the 6-minute walk test and spirometry at Visit 2
- If on routine tobramycin solution for inhalation (i.e., TOBI®) or other cycled antibiotic therapy, intention to either start or stop therapy at the time of Visit 2 (based on routine therapy cycle; no other planned change in this antibiotic regimen for 28 days before or 28 days after Visit 2)
- Clinically stable with no change in medications during the 14 days prior to screening
Exclusion Criteria:
- Use of an investigational drug or device within 28 days prior to screening
- Previous episode of acute respiratory failure requiring assisted ventilation within 2 years prior to screening
- Previous lung transplant
- Any cardiac disease that would contraindicate performing the 6-minute walk test
- Pregnancy or nursing
- Known hypersensitivity or other contraindication to the use of Pulmozyme
- Previous completion or premature discontinuation of study drug or withdrawal from this study
- More than one prior screening failure for this study at any time or any prior screening failure for this study within the last 28 days
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
2.5 mg inhalation dose twice daily for 14±2 days
|
|
Eksperimentell: Dornase alfa
|
2.5 mg inhalation dose twice daily for 14±2 days
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Distance Walked in the 6-minute Walk Test
Tidsramme: From baseline to Day 14
|
Change in distance walked was defined as (distance walked in 6 minutes at baseline [Day 0]) - (distance walked in 6 minutes at Day 14) in meters.
|
From baseline to Day 14
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pulmonary Function as Measured by FEV1 and FVC
Tidsramme: From baseline to Day 14
|
FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) were recorded at Day 0 (baseline) and Day 14. Change in FEV1 and FVC from baseline to Day 14 was reported as a percentage of values predicted for age, height, and race.
|
From baseline to Day 14
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Michelle Freemer, M.D., Genentech, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2007
Primær fullføring (Faktiske)
1. november 2008
Studiet fullført (Faktiske)
1. november 2008
Datoer for studieregistrering
Først innsendt
11. februar 2007
Først innsendt som oppfylte QC-kriteriene
11. februar 2007
Først lagt ut (Anslag)
13. februar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Z3877g
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