Richard B. Moss
Inspire Open-Label Extension study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of the study is to provide Cystic Fibrosis (CF) patients who completed 48 weeks of treatment with denufosol or placebo in Study 08-110 access to the use of denufosol as a potentially beneficial treatment for their CF lung disease. To obtain safety data for long-term safety data on denufosol in CF patients with mild lung function impairment.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Denufosol
Phase:
N/AEligibility
Ages Eligible for Study:
5 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Willing to comply with all study procedures including providing written informed consent (i.e., Patient Information Sheet) or assent (if applicable) before any study assessments and use of denufosol.
2. Completed Study 08-110 on day of Visit 1 or within 7 days of Visit 1 of the current study. Exception: Patients for whom an interruption in study drug is needed or warranted for health reasons or for administrative reasons may be enrolled within 28 days of completing Study 08-110 and must undergo rescreening assessments as described in Study Protocol Section 5.2.3 if the interruption in study drug is longer than 7 days. Enrollment of patients beyond 28 days of Visit 9 of Study 08-110 requires Sponsor approval and rescreening.
Key Exclusion Criteria:
1. A female of childbearing potential who is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device)
2. Used other investigational drugs within 30 days prior to OLE Visit 1
3. Other clinically significant comorbidities (including severe complications due to CF liver disease and CF related diabetes) that would put the patient at increased risk (in the investigator?s opinion) by study participation.
4. Condition(s) (e.g., alcoholism, drug abuse, or psychiatric disease) that might affect compliance with study procedures
Additional Study Details
Official Title:
Study 08-114: Open-label Extension of Study 08-110#A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients with Cystic Fibrosis Lung DiseaseAnticipated start date:
5/7/2009Lead Sponsor:
The Hospital for Sick ChildrenInvestigator(s):
- Richard B Moss
- Carol K. Conrad
- Carlos Milla
- Paul K Mohabir
- Terry Earl Robinson
- John David Mark
- Colleen Dunn RCP
- Zoe Davies RN
- Dr. Jacquelyn Marie Zirbes DNP
- Yan Ki Angela Leung
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
SafetyPrimary Outcomes:
- Change in lung function, as measured by absolute FEV1, from baseline to the end of treatment
Secondary Outcomes:
- Change in absolute FEV1 from baseline to each post-baseline visit (Treatment Weeks 12, 24, 36, and 48); Change in FEV1 % predicted value from baseline to the end of treatment and to each post-baseline visit (Treatment Weeks 12, 24, 36, and 48); Change in FEF25%-75% and forced vital capacity (FVC) from baseline to the end of the treatment and to each post-baseline visit (Treatment Weeks 12, 24, 36, and 48); Incidence of pulmonary exacerbations; Changes in Pseudomonas aeruginosa status (acquisition of new infection and change from non-mucoid to mucoid phenotype); Changes from baseline to OLE Visit 5 (Treatment Week 48) in patient-reported outcomes as measured by the Cystic Fibrosis Questionnaire (CFQ); Number of days of intravenous (IV) antibiotic use for a respiratory complaint; Incidence of hospitalizations/Emergency room (ER)/Accident and Emergency department (A&E) visits for a respiratory complaint; Number of days hospitalized for a respiratory complaint; Responses at OLE Visit 5 (Treatment Week 48) to the End of Study Questionnaire
Total Number to be Enrolled:
380Total Number to be Enrolled at Stanford:
5More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/14/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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