AsthmaPhase 4CONANCT02605824
Clinical Trial of NAC in Asthma
A Phase 4 study testing n-acetylcystine and 0.9% saline in people with Asthma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, which means that half the study participants will get 20% NAC in the first 7-day treatment period and placebo in the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- n-acetylcystine and 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to perform reproducible spirometry according to ATS criteria
- Clinical history consistent with moderate to severe asthma for 1 year or greater.
- Post-bronchodilator FEV1 <90% of predicted
- Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy.
- CT mucus score >3 (determined during the initial screening process, provided the prior two conditions are met)
- Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- History of intolerance to study medications.
- Current use of carbamazepine
- Angina which includes a treatment plan with PRN nitroglycerin or nitrites
- Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year smoking history
- Current participation in an investigational drug trial Concurrent Medications
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, which means that half the study participants will get 20% NAC in the first 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment period.
Read the detailed description
n-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.
Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like COPD. However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.
This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.
- Conditions
- Asthma
- Being tested
- n-acetylcystine, 0.9% saline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-acetylcystineDrug
Also called Mucomyst, NAC, acetylcystine
NAC is a mucolytic drug.
0.9% salineDrug
Also called Normal saline
Normal saline is a placebo agent.
| Study group | Role | What they receive |
|---|---|---|
| 20% n-acetylcystine (NAC) | Experimental | NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days. Receives: Drug: n-acetylcystine |
| 0.9% saline | Placebo comparator | Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days. Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-bronchodilator FEV1 (L)
This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.
Measured: 7 days
Secondary outcomes (1)
Change CT Mucus Score
The CT Mucus Score describes the number of segments of the lungs that are impacted by mucus. This outcome will compare the change in CT mucus score both at baseline and following each treatment period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: The study was closed after we determined that this albuterol/NAC regimen may be associated with excessive bronchoconstriction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John V Fahy, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605824
- Sponsor's protocol ID
- 15-17919
- Acronym
- CONA
- Status last verified
- Jul 2019
- First submitted
- 12 Nov 2015
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. doi: 10.1016/s0002-9343(03)00260-2. No abstract available.
PubMed 12867239DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.
PubMed 13818688
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of NAC in Asthma
- ClinicalTrials.gov ID
- NCT02605824
- Acronym / sponsor ID
- CONA / 15-17919
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed after we determined that this albuterol/NAC regimen may be associated with excessive bronchoconstriction.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, which means that half the study participants will get 20% NAC in the first 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment period.
Detailed description
n-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.
Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like COPD. However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.
This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% n-acetylcystine (NAC) | Experimental | Drug: n-acetylcystineNAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days. |
| 0.9% saline | Placebo comparator | Drug: 0.9% salineNormal saline will be administered as the placebo agent via a nebulizer three times per day for seven days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to perform reproducible spirometry according to ATS criteria
- Clinical history consistent with moderate to severe asthma for 1 year or greater.
- Post-bronchodilator FEV1 <90% of predicted
- Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy.
- CT mucus score >3 (determined during the initial screening process, provided the prior two conditions are met)
Key exclusion criteria (7 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- History of intolerance to study medications.
- Current use of carbamazepine
- Angina which includes a treatment plan with PRN nitroglycerin or nitrites
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-acetylcystineAlso: Mucomyst, NAC, acetylcystineNAC is a mucolytic drug. | Drug | 20% n-acetylcystine (NAC) |
| 0.9% salineAlso: Normal salineNormal saline is a placebo agent. | Drug | 0.9% saline |
Primary outcome
Change in Post-bronchodilator FEV1 (L)
Time frame: 7 days
This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.
1 secondary outcome
Change CT Mucus Score
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12867239Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. doi: 10.1016/s0002-9343(03)00260-2. No abstract available.
- Background: PubMed 13818688DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.
- Study Center WebsiteLink provided by the sponsor.
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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.
John V Fahy, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing n-acetylcystine and 0.9% saline in people with Asthma, run by University of California, San Francisco 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 6 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: stopped early, as of the sponsor's last update on 20 Aug 2019. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Post-bronchodilator FEV1 (L) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605824, which also lists 2 linked publications.
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 20 Aug 2019.