Cystic FibrosisPhase 1/2NCT00274313
Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
A Phase 1/2 study testing 552-02 in people with Cystic Fibrosis, run by Parion Sciences at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- 552-02
- How many people
- 40 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2006to Aug 2006
- Phase
- Phase 1/2
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients aged > 14 years.
- Patients who are diagnosed with cystic fibrosis.
- Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
- Patients who are able to perform reproducible spirometry according to ATS guidelines.
- Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.
Who cannot join
- Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
- Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
- Patients on angiotensin converting enzyme (ACE) inhibitors.
- Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine > 2.0 mg/dL.
- Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
- Patients who are pregnant, have a positive pregnancy test, or are nursing.
- Patients who have had a lung transplant.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Children's Memorial Hospital
Chicago, Illinois, 60614
The Children's Hospital
Denver, Colorado, 80218
Hershey Medical Center
Hershey, Pennsylvania, 17033
Morristown Memorial Hospital
Morristown, New Jersey, 07962
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5190
Nemours Children's Clinic
Orlando, Florida, 32806-1101
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California at San Diego
San Diego, California, 92161
University of California at San Francisco Medical Center
San Francisco, California, 94143-0359
State University of New York Upstate
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33606
About this study
Official title: A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis
The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
- Conditions
- Cystic Fibrosis
- Being tested
- 552-02
- Keywords
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
552-02Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
Blood and urine laboratory tests
Pulmonary function tests
Electrocardiograms
Vital signs and pulse oximetry
Secondary outcomes (1)
Plasma pharmacokinetics on Day 14 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJan 2006
- Study completionAug 2006
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Parion Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274313
- Sponsor's protocol ID
- Parion 552-203
- Status last verified
- Jan 2009
- First submitted
- 6 Jan 2006
- Last updated
- 14 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00274313
- Acronym / sponsor ID
- Parion 552-203
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Parion SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Aug 2006
- First posted
- 10 Jan 2006 (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 a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients aged > 14 years.
- Patients who are diagnosed with cystic fibrosis.
- Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
- Patients who are able to perform reproducible spirometry according to ATS guidelines.
- Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.
Key exclusion criteria (7 listed)
- Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
- Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
- Patients on angiotensin converting enzyme (ACE) inhibitors.
- Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine > 2.0 mg/dL.
- Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
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 |
|---|---|---|
| 552-02 | Drug | – |
Primary outcome
Safety assessments
Blood and urine laboratory tests
Pulmonary function tests
Electrocardiograms
Vital signs and pulse oximetry
1 secondary outcome
Plasma pharmacokinetics on Day 14 of the study.
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 14 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 552-02 in people with Cystic Fibrosis, run by Parion Sciences at 15 sites in United States.
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 5 inclusion and 7 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 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety assessments. The study lists 5 primary outcomes in all. 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 14 Jan 2009.