Cystic FibrosisPhase 2NCT00274391
Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis
A Phase 2 study testing 7% NaCl and Amiloride HCl in people with Cystic Fibrosis, run by University of North Carolina at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether the combination of inhaled amiloride and a concentrated salt solution is better than the salt solution itself for cystic fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. 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?
- 7% NaCl and Amiloride HCl
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Apr 2004
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Established diagnosis of CF
- 2 gene mutations identified, or
- Sweat chloride > 60 mmol/L, and
- 1 or more typical CF clinical features
- Age > 14 years
- Able to perform spirometry and have post-bronchodilator FEV1 > 50% of predicted at screening
- Oxyhemoglobin saturation (by pulse oximetry) > 92% on room air
- Able to provide informed consent
Who cannot join
- Unstable lung disease:
- FEV1 > 15% below best clinical measurement within 6 months
- Requirement for IV antibiotics within 4 weeks of screening
- Requirement for any change in pulmonary medication within 2 weeks of screening
- Evidence of reactive airways
- Clinical diagnosis of asthma
Show all 15Show fewer
- -> 15% increase in FEV1 after bronchodilator at screening
- Hypertonic saline use within 2 weeks of screening
- Unwilling or unable to either continue or discontinue cyclical therapies (e.g. inhaled tobramycin) for the 2 weeks prior to screening and the entire study period
- Pregnancy, breast-feeding, or unwillingness to use barrier contraception during the entire study period
- History of allergy or intolerance to amiloride, hypertonic saline, quinine, albuterol, or related compounds
- Renal insufficiency (creatinine > 1.5 mg/dl)
- Hyperkalemia (K+ > 5.0 meq/L)
- Investigational drug use within 30 days of screening
- Radiation exposure within the past year that would exceed Federal Regulations by participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
The purpose of this research study is to determine whether the combination of inhaled amiloride and a concentrated salt solution is better than the salt solution itself for cystic fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. Many patients use inhaled salt solutions to help draw water into their secretions so that they are easier to get rid of with chest physiotherapy ("chest PT") and cough. Unfortunately, these salt solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last very long. In the hopes of prolonging their effects, the drug amiloride could be used in combination to slow salt and water reabsorption from airways. Amiloride is a medication that has been given by mouth for high blood pressure for many years. It is possible that the combination of salt solutions and inhaled amiloride may significantly improve the clearance of secretions in CF, which would be expected to improve lung function in CF.
- Conditions
- Cystic Fibrosis
- Being tested
- 7% NaCl, Amiloride HCl
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7% NaClDrug
Amiloride HClDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Secondary outcomes (5)
Mucociliary clearance rate
Quality of Life
FVC
FEF25-75
Cough clearance rate
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 startJul 2001
- Study completionApr 2004
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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Investigators
- Scott H. Donaldson, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274391
- Sponsor's protocol ID
- DONALDS00A0
- Status last verified
- Dec 2005
- First submitted
- 9 Jan 2006
- Last updated
- 10 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00274391
- Acronym / sponsor ID
- DONALDS00A0
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Jul 2001
- Study completion
- Apr 2004
- 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 research study is to determine whether the combination of inhaled amiloride and a concentrated salt solution is better than the salt solution itself for cystic fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. Many patients use inhaled salt solutions to help draw water into their secretions so that they are easier to get rid of with chest physiotherapy ("chest PT") and cough. Unfortunately, these salt solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last very long. In the hopes of prolonging their effects, the drug amiloride could be used in combination to slow salt and water reabsorption from airways. Amiloride is a medication that has been given by mouth for high blood pressure for many years. It is possible that the combination of salt solutions and inhaled amiloride may significantly improve the clearance of secretions in CF, which would be expected to improve lung function in CF.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (8 listed)
- Established diagnosis of CF
- 2 gene mutations identified, or
- Sweat chloride > 60 mmol/L, and
- 1 or more typical CF clinical features
- Age > 14 years
Key exclusion criteria (15 listed)
- Unstable lung disease:
- FEV1 > 15% below best clinical measurement within 6 months
- Requirement for IV antibiotics within 4 weeks of screening
- Requirement for any change in pulmonary medication within 2 weeks of screening
- Evidence of reactive airways
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 |
|---|---|---|
| 7% NaCl | Drug | – |
| Amiloride HCl | Drug | – |
Primary outcome
FEV1
5 secondary outcomes
Mucociliary clearance rate
Quality of Life
FVC
FEF25-75
Cough clearance rate
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 10 Jan 2006.
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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.
Scott H. Donaldson, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7% NaCl and Amiloride HCl in people with Cystic Fibrosis, run by University of North Carolina 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 8 inclusion and 15 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 10 Jan 2006. 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 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?
FEV1. 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 10 Jan 2006.