Cystic FibrosisPhase 3NCT00625612
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
A Phase 3 study testing Denufosol Tetrasodium (INS37217) Inhalation Solution in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC at 106 sites in 4 countries.
Trial summary
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Denufosol Tetrasodium (INS37217) Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 466 participants
- Where
- 106 sitesin 4 countries
- Study dates
- Feb 2008to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
Trial locations and contacts
106 sites in 4 countries.
106 sites in 4 countries
United States82 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Albany Medical College
Albany, New York, 12208
Pediatric Breathing Disorders
Anchorage, Alaska, 99508
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
Medical College of Georgia
Augusta, Georgia, 30912
Austin Children's Chest Associates
Austin, Texas, 78723
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
St. Alexius Medical Center
Bismarck, North Dakota, 58501
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospital of Cleveland
Cleveland, Ohio, 44106
Columbus Children's Hospital
Columbus, Ohio, 43205
Dallas Cystic Fibrosis Center
Dallas, Texas, 75235
The Children's Medical Center of Dayton
Dayton, Ohio, 45404
Duke University Medical Center
Durham, North Carolina, 27710
Shands at University of Florida
Gainesville, Florida, 32610
Cystic Fibrosis Institute
Glenview, Illinois, 60025
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Cystic Fibrosis Center of Schneider Children's Hospital
Great Neck, New York, 11021
New York Medical College
Hawthorne, New York, 10532
PennState Milton S Hershey Med
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
James Whitcomb RIley Hospital for Children
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
Childrens Mercy Hospital
Kansas City, Missouri, 64108
East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care
Knoxville, Tennessee, 37916
Children's Lung Specialists
Las Vegas, Nevada, 83107
University of Kentucky
Lexington, Kentucky, 40536
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Monmouth Medical Center
Long Branch, New Jersey, 07740
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
USC Cystic Fibrosis Center
Los Angeles, California, 90033
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
University of Wisconsin School of Medicine and Pulbic Health
Madison, Wisconsin, 53792
Children's Health Care
Minneapolis, Minnesota, 55404
University of Minnesota - Farview
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
The Respiratory Center for Children
Morristown, New Jersey, 07960
Yale School of Medicine
New Haven, Connecticut, 06520
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Tulane University Medical Center
New Orleans, Louisiana, 70112
St. Vincent's Catholic Medical Center
New York, New York, 10011
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Bay Area Pediatric Pulmonary
Oakland, California, 94609
Kaiser Permanente Medical Center
Oakland, California, 94611
Santiago Reyes, MD
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Orange County
Orange, California, 92868
Sanford University
Palo Alto, California, 94304
Nemours Children's Clinic
Pensacola, Florida, 32504
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Maine Medical Center
Portland, Maine, 04102
Oregon Health and Science University
Portland, Oregon, 97239
Naval Medical Center Portsmouth
Portsmouth, Virginia, 84132
Pediatric Pulmonary Clinic
Richmond, Virginia, 23219
University of Rochester
Rochester, New York, 14642
Capital Allergy & Respiratory Disease Center
Sacramento, California, 95819
University of Utah
Salt Lake City, Utah, 84132
UCSD Medical Center - Hillcrest & Thornton Hospitals
San Diego, California, 92103
UCSD Medical Center - Hillcrest and Thornton Hospitals
San Diego, California, 92103
Sanford Childrens' Specialty Clinic
Sioux Falls, South Dakota, 57117
Saint Louis University
St Louis, Missouri, 63104
Pediatric Pulmonary Associates
St. Petersburg, Florida, 33701
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Tampa General Hospital
Tampa, Florida, 33606
Toledo Children's Hospital
Toledo, Ohio, 43606
University of Arizona/Arizona Health Sciences
Tucson, Arizona, 85724
Pediatric Diagnostic Center
Ventura, California, 93003
Children's National Medical Center
Washington D.C., District of Columbia, 20010
St. Mary's Medical Center
West Palm Beach, Florida, 33407
Via Christa Research
Wichita, Kansas, 67214
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Canada12 sites
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
McMaster University
Hamilton, Ontario, L8N 325
A. Lyttle Research COmpany
London, Ontario, N6A1V2
Centre Mere-Enfant du CHUL
Montreal, Quebec, HZW 1T7
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Eastern Health
St. John's, Newfoundland and Labrador, AIA 3V6
Eastern Health
St. John's, Newfoundland and Labrador, AIA346
University of Toronto
Toronto, Ontario, M5B 1W8
Hospital for Sick Children
Toronto, Ontario, MSG 1XB
St. Paul's Hospital
Vancouver, British Columbia, V621Y6
British Columbia Children's Hospital
Vancouver, British Columbia, V64 3V4
Australia11 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Prince Charles Hospital
Chermside, Queensland, 4032
Monash Medical Centre
Clayton, Victoria, 3168
Royal Brisbane Children's Hospital
Herston, Queensland, 4029
Alfred Hospital
Melbourne, Victoria, 3004
Sire Charles Gairdner Hospital
Nedlands, Western Australia, 6009
John Hunter Hospital - Adults
New Lambton, New South Wales, 2305
Respiratory Medicine
Parkville, Victoria, 3052
Princess Margaret Hospital for Children
Perth, Western Australia, 6840
Westmead Adults
Westmead, New South Wales, 2145
The Children's Hospital of Westmead
Westmead, NSW 2145
About this study
Official 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
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
- Conditions
- Cystic Fibrosis
- Being tested
- Denufosol Tetrasodium (INS37217) Inhalation Solution, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denufosol Tetrasodium (INS37217) Inhalation SolutionDrug
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
PlaceboDrug
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| 1 | Experimental | Denufosol Tetrasodium (INS37217) Inhalation Solution Receives: Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung function
Measured: 48 weeks
Secondary outcomes (1)
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Ratjen, MD, PhD, Principal investigator, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625612
- Sponsor's protocol ID
- P08640
- Other IDs
- 08-110
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2008
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ratjen F, Durham T, Navratil T, Schaberg A, Accurso FJ, Wainwright C, Barnes M, Moss RB; TIGER-2 Study Investigator Group. Long term effects of denufosol tetrasodium in patients with cystic fibrosis. J Cyst Fibros. 2012 Dec;11(6):539-49. doi: 10.1016/j.jcf.2012.05.003. Epub 2012 Jun 8.
PubMed 22682898
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00625612
- Acronym / sponsor ID
- P08640
- Conditions
- Cystic Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placebo |
| 1 | Experimental | Drug: Denufosol Tetrasodium (INS37217) Inhalation SolutionDenufosol Tetrasodium (INS37217) Inhalation Solution |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denufosol Tetrasodium (INS37217) Inhalation SolutionDrug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months. | Drug | 1 |
| PlaceboPlacebo - 0.9% w/v sodium chloride solution, three times daily for twelve months. | Drug | 2 |
Primary outcome
Change in lung function
Time frame: 48 weeks
1 secondary outcome
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Derived from this study: PubMed 22682898Ratjen F, Durham T, Navratil T, Schaberg A, Accurso FJ, Wainwright C, Barnes M, Moss RB; TIGER-2 Study Investigator Group. Long term effects of denufosol tetrasodium in patients with cystic fibrosis. J Cyst Fibros. 2012 Dec;11(6):539-49. doi: 10.1016/j.jcf.2012.05.003. Epub 2012 Jun 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Ratjen, MD, PhD principal investigator
Toronto, Canada
106 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denufosol Tetrasodium (INS37217) Inhalation Solution in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC at 106 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung function (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00625612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.