Cystic FibrosisPhase 1NCT03391414
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
A Phase 1 study testing hypertonic bicarbonate and sodium chloride in people with Cystic Fibrosis, run by Joseph Pilewski at 2 sites in United States.
Trial summary
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- hypertonic bicarbonate and sodium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Jul 2016
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FEV1 greater than 50% predicted.
- Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
- Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment.
Who cannot join
- Reactive airway disease
- Use of inhaled hypertonic saline in the past 28 days
- Use of IV antibiotics in the past 4 weeks
- Changes in CF-related medications in the four weeks prior to study screening
- SpO2 < 94% on room air or use of supplemental oxygen.
- Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux symptoms in cases of treated GERD more than three times per week.
- Pregnant or nursing females.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Fallk Clinic
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
Read the detailed description
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
- Conditions
- Cystic Fibrosis
- Being tested
- hypertonic bicarbonate, sodium chloride
- Keywords
- thick mucus, obstructive lung disease
- Medical subject headings
- Cystic Fibrosis, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic bicarbonateDrug
Also called sodium bicarbonate
8.4% sodium bicarbonate inhaled
sodium chlorideDrug
Also called hyper-sal
7% sodium chloride inhaled
| Study group | Role | What they receive |
|---|---|---|
| hypertonic bicarbonate | Experimental | subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer Receives: Drug: hypertonic bicarbonate |
| hypertonic saline | Active comparator | subjects will be administered a solution of 7% sodium chloride by nebulizer Receives: Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled breath condensate pH change
Change in pH after inhalation of two doses on one day
Measured: two time points (baseline and four (4) hours)
Secondary outcomes (2)
Expectorated sputum change
Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day
Measured: two time points (Baseline and four (4) hours)
Spirometry
FEV1 before and after inhalation of two doses on one day
Measured: two time points (baseline and four (4) hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Pilewski
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Joseph Pilewski, University of Pittsburgh
- Investigators
- Joseph M PIlewski, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391414
- Sponsor's protocol ID
- PRO09120363
- Status last verified
- Dec 2017
- First submitted
- 20 Jun 2012
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03391414
- Acronym / sponsor ID
- PRO09120363
- Conditions
- Cystic Fibrosis
- Keywords
- thick mucus, obstructive lung disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Joseph PilewskiUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Jan 2018 (actual)
- 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.
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
Detailed description
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic bicarbonate | Experimental | Drug: hypertonic bicarbonatesubjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer |
| hypertonic saline | Active comparator | Drug: sodium chloridesubjects will be administered a solution of 7% sodium chloride by nebulizer |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- FEV1 greater than 50% predicted.
- Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
- Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment.
Key exclusion criteria (7 listed)
- Reactive airway disease
- Use of inhaled hypertonic saline in the past 28 days
- Use of IV antibiotics in the past 4 weeks
- Changes in CF-related medications in the four weeks prior to study screening
- SpO2 < 94% on room air or use of supplemental oxygen.
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 |
|---|---|---|
| hypertonic bicarbonateAlso: sodium bicarbonate8.4% sodium bicarbonate inhaled | Drug | hypertonic bicarbonate |
| sodium chlorideAlso: hyper-sal7% sodium chloride inhaled | Drug | hypertonic saline |
Primary outcome
Exhaled breath condensate pH change
Time frame: two time points (baseline and four (4) hours)
Change in pH after inhalation of two doses on one day
2 secondary outcomes
Expectorated sputum change
Time frame: two time points (Baseline and four (4) hours)
Spirometry
Time frame: two time points (baseline and four (4) hours)
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 5 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Joseph M PIlewski, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hypertonic bicarbonate and sodium chloride in people with Cystic Fibrosis, run by Joseph Pilewski at 2 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 3 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 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Exhaled breath condensate pH change (time frame: two time points (baseline and four (4) hours)). 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 5 Jan 2018.