Cystic FibrosisPhase 2REACH-1NCT01181622
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
A Phase 2 study testing denufosol tetrasodium Inhalation Solution and 0.9% w/v sodium chloride solution in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- denufosol tetrasodium Inhalation Solution and 0.9% w/v sodium chloride solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Oct 2010
- Phase
- Phase 2
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a confirmed diagnosis of CF
- Have oxyhemoglobin saturation ≥ 95% prior to randomization
Who cannot join
- Have acute intercurrent respiratory infection (cough, wheezing, or new
- rhinorrhea or nasal congestion)
- Have any significant medical condition not related to CF
- Unable to discontinue use of hypertonic saline
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
- Conditions
- Cystic Fibrosis
- Being tested
- denufosol tetrasodium Inhalation Solution, 0.9% w/v sodium chloride 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
0.9% w/v sodium chloride solutionDrug
0.9% w/v sodium chloride solution 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 |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% w/v sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
Measured: Day 1, Day 7
Secondary outcomes (6)
Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose
Measured: Day 1, Day 7
Mean change from baseline in oxyhemoglobin saturation
Measured: Day 7
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs
Measured: Day 7
Mean change from pre-dose in pulse and respiratory rate at defined times post-dose
Measured: Day 1, Day 7
Mean change from baseline in pulse and respiratory rate
Measured: Day 7
Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionOct 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 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
- NCT01181622
- Sponsor's protocol ID
- P08643
- Other IDs
- 08-116
- Acronym
- REACH-1
- Status last verified
- Dec 2014
- First submitted
- 12 Aug 2010
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01181622
- Acronym / sponsor ID
- REACH-1 / P08643
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Aug 2010 (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 evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| denufosol tetrasodium Inhalation Solution | Experimental | Drug: denufosol tetrasodium Inhalation Solution |
| Placebo | Placebo comparator | Drug: 0.9% w/v sodium chloride solution |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Have a confirmed diagnosis of CF
- Have oxyhemoglobin saturation ≥ 95% prior to randomization
Key exclusion criteria (4 listed)
- Have acute intercurrent respiratory infection (cough, wheezing, or new
- rhinorrhea or nasal congestion)
- Have any significant medical condition not related to CF
- Unable to discontinue use of hypertonic saline
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 |
| 0.9% w/v sodium chloride solution0.9% w/v sodium chloride solution by oral inhalation three times daily | Drug | Placebo |
Primary outcome
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
Time frame: Day 1, Day 7
6 secondary outcomes
Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose
Time frame: Day 1, Day 7
Mean change from baseline in oxyhemoglobin saturation
Time frame: Day 7
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs
Time frame: Day 7
Mean change from pre-dose in pulse and respiratory rate at defined times post-dose
Time frame: Day 1, Day 7
Mean change from baseline in pulse and respiratory rate
Time frame: Day 7
Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline
Time frame: Day 7
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 13 Jan 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 2 study testing denufosol tetrasodium Inhalation Solution and 0.9% w/v sodium chloride 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 2 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 13 Jan 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles (time frame: Day 1, Day 7). 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 13 Jan 2015.