Cystic FibrosisPhase 1NCT00332215
A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.
A Phase 1 study testing Inhaled Sodium Pyruvate in people with Cystic Fibrosis, run by University of Minnesota at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety of inhaled sodium pyruvate in people with Cystic Fibrosis (CF). Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by FEV1, or reduce inflammatory markers in induced sputum of people with CF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Inhaled Sodium Pyruvate
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to not given
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of CF using Cystic Fibrosis Foundation criteria.
- FEV1 >40% predicted
- Colonization with Pseudomonas aeruginosa - (>= 2 positive cultures over past 12 months)
- >18 years of age
- Stable respiratory status without dyspnea at rest
- Non-smoker
- Able to perform sputum induction
Who cannot join
- Severe CF lung disease with an FEV1 of <40% predicted
- Lung disease not CF related
- Positive culture for Burkholderia cepacia over previous 2 years
- Active allergic bronchopulmonary aspergillosis
- Clinically significant cardiac disease
- Pregnancy
Show all 20Show fewer
- Females of child bearing age not using contraception
- Females lactating
- <18 years of age
- Systemic steroid treatment within 1 month
- Hospitalization within 3 months due to airway disease
- Immunotherapy
- Changes in respiratory medication use within 1 month
- New medications within 1 month
- Administration of any investigational drug or device within 28 days of visit 1 or within 6 half-lives of the investigational drug (whichever is longer).
- History of significant (>60 cc) hemoptysis within 1 year
- Poorly controlled insulin dependent diabetes mellitus
- Acute respiratory illness within 1 month
- Use of tobacco products or recreational drugs
- History of adverse reaction to sputum induction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota General Clinical Research Center
Minneapolis, Minnesota, 55455
About this study
Official title: Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study.
The primary objective of this study is to assess the safety of inhaled sodium pyruvate in people with Cystic Fibrosis (CF). Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by FEV1, or reduce inflammatory markers in induced sputum of people with CF.
Read the detailed description
Cystic fibrosis (CF) is a disease that causes airway blockage and infection that damages the lung. The lungs of CF patients are frequently loaded with inflammatory cells, damaging proteins and oxidants. Oxidants are molecules that contain oxygen and are capable of disrupting cells and tissue. The CF protein is involved in the transport of the important antioxidant glutathione (GSH). Antioxidants are molecules that block oxidants and render them inactive. The absence of this protection in the airways makes them prone to damage from oxidants. Sodium pyruvate is part of the body's natural anti-oxidant defense system. Sodium pyruvate reacts directly with oxygen radicals to neutralize them and increases cellular levels of glutathione.
The purpose of this study is to investigate the safety and tolerability of 3 different single dose levels of sodium pyruvate administered via a nebulizer to persons with CF lung disease.
This will be a phase I study with 3 stages. In the first stage subjects will receive one of 3 possible doses of the active drug only once. In the second stage subjects will receive 2 doses of the active drug 12 hours apart. In the third stage subjects will receive either active drug or placebo every 12 hours for 4 weeks.
For stage 1 subjects will come to the University of Minnesota's General Clinical Research Center (GCRC) for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. The subject will be observed for 4 hours and safety parameters will be obtained.
For stage 2 subjects will come to the GCRC for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. Safety parameters will be obtained for the following 4 hours. 12 hours after the first dose was given the subject will receive a second dose and safety parameters will again be obtained over the next 4 hours.
For stage 3 subjects will come to the GCRC for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. Safety parameters will be obtained for the following 4 hours. The subject will be sent home to continue on study drug every 12 hours for the following 4 weeks. The subject will be asked to return to the GCRC once a week for safety assessments.
- Conditions
- Cystic Fibrosis
- Being tested
- Inhaled Sodium Pyruvate
- Keywords
- Cystic Fibrosis, Antioxidants, Inhalational therapy, Induced sputum, Airway inflammation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Sodium PyruvateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.Subjects will be evaluated for the presence of symptoms and safety laboratory measurements.
Secondary outcomes (1)
The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and measurement of inflammatory markers in induced sputum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startFeb 2006
Why it stopped: Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Cellular Sciences, inc.
- Investigators
- Carlos E Milla, MD, Principal investigator, University of MinnesotaJoanne L Billings, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332215
- Sponsor's protocol ID
- 0511M77511
- Other IDs
- CSI-N115-I-010-01
- Status last verified
- Nov 2008
- First submitted
- 30 May 2006
- Last updated
- 1 Dec 2008
- Results posted
- No
Publications
O'Donnell-Tormey J, Nathan CF, Lanks K, DeBoer CJ, de la Harpe J. Secretion of pyruvate. An antioxidant defense of mammalian cells. J Exp Med. 1987 Feb 1;165(2):500-14. doi: 10.1084/jem.165.2.500.
PubMed 3102672Votto J, Bowen J, Metersky M, Thrall R. Effect of Inhaled Sodium Pyruvate in Patients with Mild Bronchial Asthma. Am J Resp Crit Care Med 2001, 163 (5S):A860.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study.
- ClinicalTrials.gov ID
- NCT00332215
- Acronym / sponsor ID
- 0511M77511
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Antioxidants, Inhalational therapy, Induced sputum, Airway inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Cellular Sciences, inc.
- Study start
- Feb 2006
- First posted
- 1 Jun 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 primary objective of this study is to assess the safety of inhaled sodium pyruvate in people with Cystic Fibrosis (CF). Further, to determine whether inhaled sodium pyruvate will improve lung function, as determined by FEV1, or reduce inflammatory markers in induced sputum of people with CF.
Detailed description
Cystic fibrosis (CF) is a disease that causes airway blockage and infection that damages the lung. The lungs of CF patients are frequently loaded with inflammatory cells, damaging proteins and oxidants. Oxidants are molecules that contain oxygen and are capable of disrupting cells and tissue. The CF protein is involved in the transport of the important antioxidant glutathione (GSH). Antioxidants are molecules that block oxidants and render them inactive. The absence of this protection in the airways makes them prone to damage from oxidants. Sodium pyruvate is part of the body's natural anti-oxidant defense system. Sodium pyruvate reacts directly with oxygen radicals to neutralize them and increases cellular levels of glutathione.
The purpose of this study is to investigate the safety and tolerability of 3 different single dose levels of sodium pyruvate administered via a nebulizer to persons with CF lung disease.
This will be a phase I study with 3 stages. In the first stage subjects will receive one of 3 possible doses of the active drug only once. In the second stage subjects will receive 2 doses of the active drug 12 hours apart. In the third stage subjects will receive either active drug or placebo every 12 hours for 4 weeks.
For stage 1 subjects will come to the University of Minnesota's General Clinical Research Center (GCRC) for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. The subject will be observed for 4 hours and safety parameters will be obtained.
For stage 2 subjects will come to the GCRC for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. Safety parameters will be obtained for the following 4 hours. 12 hours after the first dose was given the subject will receive a second dose and safety parameters will again be obtained over the next 4 hours.
For stage 3 subjects will come to the GCRC for a screening visit. They will return to the GCRC 1 to 7 days later for a baseline assessment that will be followed by study drug administration. Safety parameters will be obtained for the following 4 hours. The subject will be sent home to continue on study drug every 12 hours for the following 4 weeks. The subject will be asked to return to the GCRC once a week for safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of CF using Cystic Fibrosis Foundation criteria.
- FEV1 >40% predicted
- Colonization with Pseudomonas aeruginosa - (>= 2 positive cultures over past 12 months)
- >18 years of age
- Stable respiratory status without dyspnea at rest
Key exclusion criteria (20 listed)
- Severe CF lung disease with an FEV1 of <40% predicted
- Lung disease not CF related
- Positive culture for Burkholderia cepacia over previous 2 years
- Active allergic bronchopulmonary aspergillosis
- Clinically significant cardiac disease
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 |
|---|---|---|
| Inhaled Sodium Pyruvate | Drug | – |
Primary outcome
The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.Subjects will be evaluated for the presence of symptoms and safety laboratory measurements.
1 secondary outcome
The secondary outcome variable is the determination of improvement in lungs of CF subjects as determined by measurement of FEV1 and measurement of inflammatory markers in induced sputum.
Results and safety
The study was stopped early (reason given: Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2008.
- Background: PubMed 3102672O'Donnell-Tormey J, Nathan CF, Lanks K, DeBoer CJ, de la Harpe J. Secretion of pyruvate. An antioxidant defense of mammalian cells. J Exp Med. 1987 Feb 1;165(2):500-14. doi: 10.1084/jem.165.2.500.
- BackgroundVotto J, Bowen J, Metersky M, Thrall R. Effect of Inhaled Sodium Pyruvate in Patients with Mild Bronchial Asthma. Am J Resp Crit Care Med 2001, 163 (5S):A860.
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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.
Carlos E Milla, MD principal investigator
University of Minnesota
Joanne L Billings, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled Sodium Pyruvate in people with Cystic Fibrosis, run by University of Minnesota at 1 site 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 7 inclusion and 20 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 1 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 (reason given: Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.). 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?
The primary outcome variable is the assessment of safety of inhaled sodium pyruvate in subjects with CF.Subjects will be evaluated for the presence of symptoms and safety laboratory measurements.. 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 NCT00332215, which also lists 2 linked publications.
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 1 Dec 2008.