A Clinical Trial for CTD-ILD Treatment
Study Details
Study Description
Brief Summary
The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests, along with patient reports of medication intolerance and change in symptoms of dyspnea.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: N-Acetylcysteine This is an open label trial, all patient will be entered into one treatment arm. |
Drug: N-Acetylcysteine
600mg by mouth, three times daily for 12 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pulmonary Function Tests [Every 3 months]
Not recorded. Study terminated due to departure of PI.
Eligibility Criteria
Criteria
Inclusion:
-
Subject gives voluntary written informed consent to participate in the study.
-
Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.
-
Males and females age greater than 18 years at time of screening.
-
Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.
Exclusion:
-
History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
-
Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
-
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00049434
Study Results
Participant Flow
| Recruitment Details | 5 subjects consented but did not participate in study due to departure of PI from institution. |
|---|---|
| Pre-assignment Detail | 5 subjects consented to participate due to the PI departed the institution. Numbers in patient flow were updated to reflect this. |
| Arm/Group Title | N-Acetylcysteine |
|---|---|
| Arm/Group Description | This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months |
| Period Title: Overall Study | |
| STARTED | 5 |
| COMPLETED | 0 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | N-Acetylcysteine |
|---|---|
| Arm/Group Description | This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months |
| Overall Participants | 5 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
5
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
50
(5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
80%
|
| Male |
1
20%
|
| Region of Enrollment (participants) [Number] | |
| United States |
5
100%
|
Outcome Measures
| Title | Pulmonary Function Tests |
|---|---|
| Description | Not recorded. Study terminated due to departure of PI. |
| Time Frame | Every 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | N-Acetylcysteine |
|---|---|
| Arm/Group Description | This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months |
| Measure Participants | 0 |
|
0
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | N-Acetylcysteine | |
| Arm/Group Description | This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months | |
All Cause Mortality |
||
| N-Acetylcysteine | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| N-Acetylcysteine | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/5 (60%) | |
| Cardiac disorders | ||
| Death | 1/5 (20%) | 1 |
| Hospitalization, tachycardia | 1/5 (20%) | 1 |
| Reproductive system and breast disorders | ||
| Cancer recurrence | 1/5 (20%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| N-Acetylcysteine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jan Stevens |
|---|---|
| Organization | University of Michigan |
| Phone | 7349365566 |
| janstev@med.umich.edu |
- HUM00049434