Cystic FibrosisNCT00219895
Assessment of Inflammatory Mediators (AIM)
A study testing Ibuprofen in people with Cystic Fibrosis, run by Ramsey, Bonnie, MD at 16 sites in United States.
Trial summary
Specific Aim: To determine whether neutrophils, active elastase, and cytokines measured in sputum induced using hypertonic saline are useful screening tests for determining if a particular agent with known anti-inflammatory properties is a suitable candidate for more extensive clinical trials in patients with CF. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Ibuprofen
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2004to Mar 2006
- Phase
- Interventional
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 10 years of age or older.
- Confirmed diagnosis of CF based on the following criteria:
- positive sweat chloride >= 60 mEq/liter (by pilocarpine iontophoresis) and/or
- a genotype with two identifiable mutations consistent with CF, and
- accompanied by one or more clinical features consistent with the CF phenotype
- FEV1 >= 50% predicted value (subjects >= 10 - <18 years of age) or >= 40% predicted value (subjects >= 18 years of age)
Show all 9Show fewer
- Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0)
- Ability to reproducibly perform spirometry and peak flow measurements
- Ability to understand and sign a written informed consent or assent and comply with the requirements of the study
Who cannot join
- Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0)
- Chronic daily use of ibuprofen, celecoxib, or other selective COX-2 inhibitors, other NSAIDs, or systemic or inhaled corticosteroids within the 4 weeks prior to Visit 1 (Day 0) or acute usage within 72 hours prior to Visit 1 (Day 0)
- History of hypersensitivity to beta-agonists
- History of hypersensitivity to sulfonamides, aspirin, or other NSAIDs
- Oxygen saturation < 92% on room air at Visit 1 (Day 0)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Show all 12Show fewer
- History of hemoptysis >= 30 cc per episode during the 30 days prior to Visit 1 (Day 0)
- Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
- SGOT (ALT) or SGPT (AST) > 3 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension
- Creatinine > 1.8 mg/dL at screening
- Inability to swallow pills
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35223
Massachusetts General Hospital
Boston, Massachusetts, 02114
Harvard University - Children's Hospital of Boston, Pulmonary Division
Boston, Massachusetts, 02115
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Case Western Reserve University - Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Columbus Children's Hospital
Columbus, Ohio, 43205-2696
University of Colorado Health Sciences Center - Children's Hospital
Denver, Colorado, 80218
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University Of Minnesota
Minneapolis, Minnesota, 55455
Stanford University - Packard Children's Hospital
Palo Alto, California, 94304
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
University of California - San Diego
San Diego, California, 92123
Washington University - St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis
Specific Aim: To determine whether neutrophils, active elastase, and cytokines measured in sputum induced using hypertonic saline are useful screening tests for determining if a particular agent with known anti-inflammatory properties is a suitable candidate for more extensive clinical trials in patients with CF. This aim will be addressed using an anti-inflammatory agent, ibuprofen, that has been shown to have clinical benefit in CF. A "no treatment" arm will be included as the control group.
Read the detailed description
Inflammation clearly contributes to the progression of cystic fibrosis (CF) lung disease. Anti-inflammatory therapy with alternate-day corticosteroids and twice-daily high-dose ibuprofen in patients with CF has shown clinical benefit, but adverse effects and other considerations have markedly limited their use. Therefore, alternative anti-inflammatory agents are urgently needed. Results from the clinical trials of alternate-day corticosteroids and high-dose ibuprofen in CF indicate that anti-inflammatory therapy will probably not result in improvement in pulmonary function, but will slow the rate of decline. This expectation imposes constraints on the design of studies to test new anti-inflammatory agents, requiring that they use many patients over a considerable period of time (years, rather than the months that are necessary to evaluate anti-infective or anti-obstructive therapies). Thus, it is highly desirable to design a strategy for evaluation of prospective anti-inflammatory agents that will allow for the selection of only the most promising agents for further study in Phase III type trials. Of additional concern is the fact that some pharmaceutical firms have not pursued development of anti-inflammatory agents for CF because there were no early indicators of efficacy. This presents an insurmountable hurdle for translation of research advances into clinical treatments. Some means of screening candidate drugs is urgently required. This study will assess the measurement of inflammatory mediators in induced sputum as one such strategy. The hypothesis to be tested is that ibuprofen will reduce neutrophils, active elastase, and pro-inflammatory cytokines in induced sputum after 4 weeks of therapy in patients with CF.
- Conditions
- Cystic Fibrosis
- Being tested
- Ibuprofen
- Keywords
- Cystic Fibrosis, Anti-inflammatory Agents, Ibuprofen
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in markers of inflammation in induced sputum samples: total white cell count, total neutrophil count, percent neutrophils, active elastase, and cytokines.
Secondary outcomes (1)
(1) Alterations in laboratory evaluations: CBC, ESR, CRP, serum chemistry profile, urinalysis, and spirometry. (2) Adverse events associated with sputum induction or administration of study medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2004
- Study completionMar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Ramsey, Bonnie, MD
- Collaborators
- Cystic Fibrosis Foundation
- Investigators
- James Chmiel, MD, MPH, Principal investigator, Case Western Reserve University - Rainbow Babies and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219895
- Sponsor's protocol ID
- CFOM0003
- Status last verified
- Aug 2006
- First submitted
- 16 Sep 2005
- Last updated
- 25 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00219895
- Acronym / sponsor ID
- CFOM0003
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Anti-inflammatory Agents, Ibuprofen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Ramsey, Bonnie, MD
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Aug 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Specific Aim: To determine whether neutrophils, active elastase, and cytokines measured in sputum induced using hypertonic saline are useful screening tests for determining if a particular agent with known anti-inflammatory properties is a suitable candidate for more extensive clinical trials in patients with CF. This aim will be addressed using an anti-inflammatory agent, ibuprofen, that has been shown to have clinical benefit in CF. A "no treatment" arm will be included as the control group.
Detailed description
Inflammation clearly contributes to the progression of cystic fibrosis (CF) lung disease. Anti-inflammatory therapy with alternate-day corticosteroids and twice-daily high-dose ibuprofen in patients with CF has shown clinical benefit, but adverse effects and other considerations have markedly limited their use. Therefore, alternative anti-inflammatory agents are urgently needed. Results from the clinical trials of alternate-day corticosteroids and high-dose ibuprofen in CF indicate that anti-inflammatory therapy will probably not result in improvement in pulmonary function, but will slow the rate of decline. This expectation imposes constraints on the design of studies to test new anti-inflammatory agents, requiring that they use many patients over a considerable period of time (years, rather than the months that are necessary to evaluate anti-infective or anti-obstructive therapies). Thus, it is highly desirable to design a strategy for evaluation of prospective anti-inflammatory agents that will allow for the selection of only the most promising agents for further study in Phase III type trials. Of additional concern is the fact that some pharmaceutical firms have not pursued development of anti-inflammatory agents for CF because there were no early indicators of efficacy. This presents an insurmountable hurdle for translation of research advances into clinical treatments. Some means of screening candidate drugs is urgently required. This study will assess the measurement of inflammatory mediators in induced sputum as one such strategy. The hypothesis to be tested is that ibuprofen will reduce neutrophils, active elastase, and pro-inflammatory cytokines in induced sputum after 4 weeks of therapy in patients with CF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female 10 years of age or older.
- Confirmed diagnosis of CF based on the following criteria:
- FEV1 >= 50% predicted value (subjects >= 10 - <18 years of age) or >= 40% predicted value (subjects >= 18 years of age)
- Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0)
- Ability to reproducibly perform spirometry and peak flow measurements
Key exclusion criteria (12 listed)
- Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0)
- Chronic daily use of ibuprofen, celecoxib, or other selective COX-2 inhibitors, other NSAIDs, or systemic or inhaled corticosteroids within the 4 weeks prior to Visit 1 (Day 0) or acute usage within 72 hours prior to Visit 1 (Day 0)
- History of hypersensitivity to beta-agonists
- History of hypersensitivity to sulfonamides, aspirin, or other NSAIDs
- Oxygen saturation < 92% on room air at Visit 1 (Day 0)
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 |
|---|---|---|
| Ibuprofen | Drug | – |
Primary outcome
Changes in markers of inflammation in induced sputum samples: total white cell count, total neutrophil count, percent neutrophils, active elastase, and cytokines.
1 secondary outcome
(1) Alterations in laboratory evaluations: CBC, ESR, CRP, serum chemistry profile, urinalysis, and spirometry. (2) Adverse events associated with sputum induction or administration of study medications
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 25 Dec 2007.
Related trials for Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
James Chmiel, MD, MPH principal investigator
Case Western Reserve University - Rainbow Babies and Children's Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Cystic Fibrosis, run by Ramsey, Bonnie, MD at 16 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 9 inclusion and 12 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 25 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
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?
Changes in markers of inflammation in induced sputum samples: total white cell count, total neutrophil count, percent neutrophils, active elastase, and cytokines.. 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 25 Dec 2007.