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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00625612




Registration number
NCT00625612
Ethics application status
Date submitted
12/02/2008
Date registered
28/02/2008
Date last updated
1/11/2015

Titles & IDs
Public title
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
Scientific title
A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted
Secondary ID [1] 0 0
08-110
Secondary ID [2] 0 0
P08640
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Denufosol Tetrasodium (INS37217) Inhalation Solution
Treatment: Drugs - Placebo

Placebo comparator: 2 -

Experimental: 1 - Denufosol Tetrasodium (INS37217) Inhalation Solution


Treatment: Drugs: Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.

Treatment: Drugs: Placebo
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in lung function
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
Timepoint [1] 0 0
48 weeks

Eligibility
Key inclusion criteria
* Have confirmed diagnosis of cystic fibrosis
* Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
* Be able to reproducibly perform spirometry
* Be clinically stable for at least 4 weeks before screening
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have abnormal renal or liver function
* Have lung transplant
* Unable to discontinue use of hypertonic saline
* Participated in Inspire trial 08-108

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
466
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Adults - New Lambton
Recruitment hospital [2] 0 0
Westmead Adults - Westmead
Recruitment hospital [3] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Royal Brisbane Children's Hospital - Herston
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Respiratory Medicine - Parkville
Recruitment hospital [9] 0 0
Sire Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [11] 0 0
The Children's Hospital of Westmead - Westmead
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
6840 - Perth
Recruitment postcode(s) [11] 0 0
NSW 2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
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California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
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Florida
Country [9] 0 0
United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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United States of America
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Tennessee
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Texas
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Utah
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Virginia
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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [39] 0 0
Alberta
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Canada
State/province [40] 0 0
British Columbia
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Canada
State/province [41] 0 0
Newfoundland and Labrador
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Canada
State/province [42] 0 0
Nova Scotia
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Canada
State/province [43] 0 0
Ontario
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Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
New Zealand
State/province [45] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Felix Ratjen, MD, PhD
Address 0 0
Toronto, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00625612