Idiopathic Pulmonary Fibrosis (IPF)Phase 1/2NCT03720483
Inhaled NAC in Treatment of IPF
A Phase 1/2 study of Idiopathic Pulmonary Fibrosis (IPF), run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Dec 2023
- Phase
- Phase 1/2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed by study team with expertise in IPF utilizing standard ATS/ERS definition of "probable" or "definite" IPF
- DLCO >50% predicted
- FVC >60% predicted
- FEV1/FVC > 0.7
Who cannot join
- History of bronchospasm (requiring treatment)
- Current acute exacerbation of their IPF disease
- Current smoker
- Supplemental O2 requirement > 4 liters/min via nasal cannula
- History of asthma, COPD, coronary artery disease, or cancer
- Currently using NAC, hypertonic saline, or DNase (dornase alfa) inhalation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.
Read the detailed description
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.
NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- N-acetyl cysteine then Placebo, Placebo then N-acetyl cysteine
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteine then PlaceboDrug
Subject will receive N-acetyl cysteine first followed by Placebo
Placebo then N-acetyl cysteineDrug
Subject will receive Placebo first followed by N-acetyl cysteine
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl cysteine then placebo | Experimental | This arm will receive NAC followed by placebo Receives: Drug: N-acetyl cysteine then Placebo |
| Placebo then N-acetyl cysteine | Experimental | This arm will receive placebo followed by NAC Receives: Drug: Placebo then N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pulmonary function - FVC
Measure changes in percent predicted FVC
Measured: Baseline, week 10, and week 18
Changes in Pulmonary function - DLCO
Measure changes in percent predicted DLCO
Measured: Baseline, week 10, and week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study startJan 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: The study encountered challenges during startup due to the COVID-19 epidemic and was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Steele, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720483
- Sponsor's protocol ID
- 17-1477
- Status last verified
- Jun 2021
- First submitted
- 18 Jul 2018
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03720483
- Acronym / sponsor ID
- 17-1477
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study encountered challenges during startup due to the COVID-19 epidemic and was withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Oct 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 plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.
Detailed description
This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.
NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl cysteine then placebo | Experimental | Drug: N-acetyl cysteine then PlaceboThis arm will receive NAC followed by placebo |
| Placebo then N-acetyl cysteine | Experimental | Drug: Placebo then N-acetyl cysteineThis arm will receive placebo followed by NAC |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed by study team with expertise in IPF utilizing standard ATS/ERS definition of "probable" or "definite" IPF
- DLCO >50% predicted
- FVC >60% predicted
- FEV1/FVC > 0.7
Key exclusion criteria (6 listed)
- History of bronchospasm (requiring treatment)
- Current acute exacerbation of their IPF disease
- Current smoker
- Supplemental O2 requirement > 4 liters/min via nasal cannula
- History of asthma, COPD, coronary artery disease, or cancer
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 |
|---|---|---|
| N-acetyl cysteine then PlaceboSubject will receive N-acetyl cysteine first followed by Placebo | Drug | N-acetyl cysteine then placebo |
| Placebo then N-acetyl cysteineSubject will receive Placebo first followed by N-acetyl cysteine | Drug | Placebo then N-acetyl cysteine |
Primary outcome
Changes in Pulmonary function - FVC
Time frame: Baseline, week 10, and week 18
Measure changes in percent predicted FVC
Changes in Pulmonary function - DLCO
Time frame: Baseline, week 10, and week 18
Measure changes in percent predicted DLCO
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- 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.
Mark Steele, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Idiopathic Pulmonary Fibrosis (IPF), run by University of Colorado, Denver 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Jun 2021. 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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 Pulmonary function - FVC (time frame: Baseline, week 10, and week 18). The study lists 2 primary outcomes in all. 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 8 Jun 2021.