Cystic FibrosisPhase 3DEFYNCT00846781
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 Disease (P08642)
A Phase 3 study testing Denufosol tetrasodium Inhalation Solution in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol. 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 Inhalation Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Feb 2011
- 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
- Completed Study 08-110
Who cannot join
- A female patient will not be eligible for the study if she is of childbearing potential and 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).
- Have a condition that might affect compliance with study procedures
About this study
The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.
- Conditions
- Cystic Fibrosis
- Being tested
- Denufosol tetrasodium Inhalation Solution
- 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 Inhalation SolutionDrug
60 mg by oral inhalation three times daily
| Study group | Role | What they receive |
|---|---|---|
| Denufosol tetrasodium Inhalation Solution | Experimental | Not described Receives: Drug: Denufosol tetrasodium Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in lung function, as measured by change in FEV1
Measured: 160 Weeks
Secondary outcomes (14)
Change in absolute FEV1 from baseline
Measured: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Change in FEV1 percent predicted value from baseline
Measured: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Change in FEF25%-75% and forced vital capacity (FVC) from baseline
Measured: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Incidence of pulmonary exacerbations
Measured: 160 Weeks
Changes in Pseudomonas aeruginosa status
Measured: 160 Weeks
Number of days of intravenous (IV) antibiotic use for a respiratory complaint
Measured: 160 Weeks
Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint
Measured: 160 Weeks
Number of days hospitalized for a respiratory complaint
Measured: 160 Weeks
Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs
Measured: 160 Weeks
Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline
Measured: 160 Weeks
Changes in physical exam findings including height, weight, and body mass index from baseline
Measured: Weeks 48, 96, and 160
Changes in hematology, serum chemistry, and urinalysis parameters from baseline
Measured: Weeks 24, 48, 72, 96, 120, 144, and 160
Incidence of hospitalizations/ER visits
Measured: 160 Weeks
Incidence of early discontinuations from the study
Measured: 160 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynn Smiley, MD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846781
- Sponsor's protocol ID
- P08642
- Other IDs
- 08-114
- Acronym
- DEFY
- Status last verified
- Oct 2015
- First submitted
- 18 Feb 2009
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Disease (P08642)
- ClinicalTrials.gov ID
- NCT00846781
- Acronym / sponsor ID
- DEFY / P08642
- Conditions
- Cystic Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Feb 2009 (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 study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denufosol tetrasodium Inhalation Solution | Experimental | Drug: Denufosol tetrasodium 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 (1 listed)
- Completed Study 08-110
Key exclusion criteria (2 listed)
- A female patient will not be eligible for the study if she is of childbearing potential and 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).
- Have a condition that might affect compliance with study procedures
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 Inhalation Solution60 mg by oral inhalation three times daily | Drug | Denufosol tetrasodium Inhalation Solution |
Primary outcome
Rate of change in lung function, as measured by change in FEV1
Time frame: 160 Weeks
14 secondary outcomes
Change in absolute FEV1 from baseline
Time frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Change in FEV1 percent predicted value from baseline
Time frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Change in FEF25%-75% and forced vital capacity (FVC) from baseline
Time frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
Incidence of pulmonary exacerbations
Time frame: 160 Weeks
Changes in Pseudomonas aeruginosa status
Time frame: 160 Weeks
Number of days of intravenous (IV) antibiotic use for a respiratory complaint
Time frame: 160 Weeks
Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint
Time frame: 160 Weeks
Number of days hospitalized for a respiratory complaint
Time frame: 160 Weeks
Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs
Time frame: 160 Weeks
Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline
Time frame: 160 Weeks
Changes in physical exam findings including height, weight, and body mass index from baseline
Time frame: Weeks 48, 96, and 160
Changes in hematology, serum chemistry, and urinalysis parameters from baseline
Time frame: Weeks 24, 48, 72, 96, 120, 144, and 160
Incidence of hospitalizations/ER visits
Time frame: 160 Weeks
Incidence of early discontinuations from the study
Time frame: 160 Weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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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.
Lynn Smiley, MD study director
Medical Monitor
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denufosol tetrasodium Inhalation Solution in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early. Results are not available in the source record.
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?
Rate of change in lung function, as measured by change in FEV1 (time frame: 160 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2015.