Cystic FibrosisPhase 1NCT00311883
Hydroxychloroquine in Cystic Fibrosis
A Phase 1 study testing hydroxychloroquine in people with Cystic Fibrosis, run by Vanderbilt University at 1 site in United States.
Trial summary
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- hydroxychloroquine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2007
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female between 16 years and 65 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- positive sweat chloride 60 mEq/liter (by pilocarpine iontophoresis) and/or ii. a genotype with two identifiable mutations consistent with CF, and iii. accompanied by one or more clinical features consistent with the CF phenotype
- FEV1 50% predicted value (subjects 16- <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
- 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
- Chronic daily use of ibuprofen or other NSAIDs, or systemic corticosteroids, or any oral diabetic or hypoglycemic agent within the 4 weeks prior to Visit 1 or acute usage within 72 hours prior to Visit 1
- History of hypersensitivity to beta-agonists
- History of hypersensitivity to hydroxychloroquine or chloroquine
- Oxygen saturation < 92% on room air at Visit 1
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- History of hemoptysis 30 cc per episode during the 30 days prior to Visit 1
- Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.
Read the detailed description
Open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate pH in patients with cystic fibrosis. Patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an FEV1 greater than 40% predicted will be eligible for enrollment. Enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. Inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate pH will be measure at entry and at the end of 4 weeks of oral drug. There will be no placebo group.
- Conditions
- Cystic Fibrosis
- Being tested
- hydroxychloroquine
- Keywords
- Cystic Fibrosis, Induced sputum, Lung inflammation
- Medical subject headings
- Cystic Fibrosis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory mediators and exhaled breath condensate pH following 4 week administration of drug.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Bonnie S Slovis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311883
- Sponsor's protocol ID
- 060051
- Status last verified
- Jan 2008
- First submitted
- 4 Apr 2006
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00311883
- Acronym / sponsor ID
- 060051
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Induced sputum, Lung inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Apr 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.
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.
Detailed description
Open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate pH in patients with cystic fibrosis. Patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an FEV1 greater than 40% predicted will be eligible for enrollment. Enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. Inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate pH will be measure at entry and at the end of 4 weeks of oral drug. There will be no placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between 16 years and 65 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- FEV1 50% predicted value (subjects 16- <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 (8 listed)
- Use of an investigational agent within the 4-week period prior to Visit 1
- Chronic daily use of ibuprofen or other NSAIDs, or systemic corticosteroids, or any oral diabetic or hypoglycemic agent within the 4 weeks prior to Visit 1 or acute usage within 72 hours prior to Visit 1
- History of hypersensitivity to beta-agonists
- History of hypersensitivity to hydroxychloroquine or chloroquine
- Oxygen saturation < 92% on room air at Visit 1
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 |
|---|---|---|
| hydroxychloroquine | Drug | – |
Primary outcome
Change in inflammatory mediators and exhaled breath condensate pH following 4 week administration of drug.
Time frame: 28 days
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 30 Jan 2008.
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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.
Bonnie S Slovis, MD principal investigator
Vanderbilt University
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 hydroxychloroquine in people with Cystic Fibrosis, run by Vanderbilt University 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 8 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 30 Jan 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 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?
Change in inflammatory mediators and exhaled breath condensate pH following 4 week administration of drug. (time frame: 28 days). 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 30 Jan 2008.