Pulmonary FibrosisPhase 1NCT00563212
A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis
A Phase 1 study testing aerosol interferon-gamma in people with Pulmonary Fibrosis, run by NYU Langone Health at 1 site in United States.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective treatment. Interferon-gamma is a medication that has been used for other lung diseases to decrease scarring and fibrosis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- aerosol interferon-gamma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 1 Dec 2018
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with IPF based on accepted criteria (see above) within 12 months prior to screening.
- Age 40-75.
- Absence of significant pulmonary hypertension as measured by right heart catheterization (mPAP ≥ 30 mmHG) or echocardiography (RVSP ≥ 50 mmHg).
- FVC ≥ 55% of predicted baseline value at screening; DLCO ≥ 30% predicted.
- PaO2 ≥ 65 mm Hg at rest on room air
- Patient able to understand and willing to sign a written informed consent and willing to comply with all requirements of the study protocol including lung deposition studies.
- Patient fits criteria for research bronchoscopy and is willing to undergo procedure.
Who cannot join
- Six minute walk distance of < 200 meters.
- Patient unwilling or unable to undergo research bronchoscopy.
- Patient with known life threatening asthma or severe COPD.
- Patient requiring oxygen therapy for maintenance of adequate arterial oxygenation at rest.
- Patient with hypersensitivity to study medication or other component medication.
- Patient with known severe cardiac disease, severe peripheral vascular disease or seizure disorder which may be exacerbated by study drug administration (contraindications to drug administration as per package insert).
Show all 17Show fewer
- Pregnant or lactating; Females of child-bearing potential will be required to have negative pregnancy test and be required to use accepted form of birth control (abstinence for study duration is the preferred method).
- Evidence of active infection within one week prior to treatment.
- Any condition, other than IPF, which is likely to result in the death of the patient within one year from study enrollment.
- Abnormal serum laboratory values including:
- Liver function above specified limits: total bilirubin > 1.5 X upper limits of normal, alanine amino transferase > 3X upper limit of normal, alkaline phosphatase > 3X upper limit of normal, albumin < 3.0 at screening.
- CBC outside specified limits: WBC < 2,500/mm3, hematocrit < 30 or > 59, platelets < 100,000/mm3.
- Creatinine > 1.5X upper limits normal at screening.
- Drugs for therapy for pulmonary fibrosis, including corticosteroids, azathioprine and/or cyclophosphamide, or n-acetylcysteine within the previous six weeks.
- Prior therapy with any class of interferon medication.
- Investigational therapy for any indication within the last 28 days.
- In a pulmonary rehabilitation program or planning to attend a pulmonary rehabilitation program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Pulmonary & Critical Care Medicine, NYU School of Medicine
New York, New York, 10016
About this study
Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective treatment. Interferon-gamma is a medication that has been used for other lung diseases to decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not show any improvement in survival in patients with IPF. We hypothesize that giving interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in a way that decreases fibrosis.
Read the detailed description
Patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) will be enrolled in a phase I study of aerosol interferon-gamma (IFN-γ). Prior to initiation of treatment, patients will undergo CT of the chest, pulmonary function testing, and bronchoscopy with bronchoalveolar lavage. They will also undergo a lung deposition study to determine the lung dose of IFN-γ that will be delivered with each treatment. Patients will then receive aerosol IFN-γ 100mcg delivered three times weekly via nebulizer for one year. Study patients will be followed monthly to monitor potential side effects, vital signs, and progression of IPF symptoms. Labs will be drawn at regular intervals to monitor for side effects and to measure cytokine levels. Bronchoscopy will be performed at the 6 and/or 12 month visit to compare cytokine levels pre-, during, and post-treatment.
- Conditions
- Pulmonary Fibrosis
- Being tested
- aerosol interferon-gamma
- Keywords
- Lung Diseases, Interstitial, Fibrosis, Interferons, Pulmonary Fibrosis, Pathologic Processes, Lung Diseases, Fibrosing alveolitis, Interferon-gamma, Recombinant, Aerosols
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Interstitial, Fibrosis, Pathologic Processes, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosol interferon-gammaDrug
aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: aerosol interferon-gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety, tolerability
Measured: one year
Secondary outcomes (1)
lung deposition of aerosolized IFN, bronchoalveolar lavage fluid levels of IFN and fibrotic cytokines pre-and post-treatment, pulmonary function testing trends during treatment, descriptive data regarding symptoms and clinical findings
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJan 2007
- Primary completion1 Jun 2010
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), Stony Brook University, Philips Respironics
- Responsible party
- Sponsor
- Investigators
- Rany Condos, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563212
- Sponsor's protocol ID
- 9583
- Other IDs
- IFB 9583
- Status last verified
- Apr 2020
- First submitted
- 21 Nov 2007
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Goldyn SR, Smaldone GC, Rom WN, Condos R. Safety Profile of Aerosol Interferon-gamma. Abstract submitted to American Thoracic Society for presentation at ATS annual meeting May 2008, Toronto.
Xue Y, Reddy SK, Garza LA. Toward Understanding Wound Immunology for High-Fidelity Skin Regeneration. Cold Spring Harb Perspect Biol. 2022 Jul 1;14(7):a041241. doi: 10.1101/cshperspect.a041241.
PubMed 35667792
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00563212
- Acronym / sponsor ID
- 9583
- Conditions
- Pulmonary Fibrosis
- Keywords
- Lung Diseases, Interstitial, Fibrosis, Interferons, Pulmonary Fibrosis, Pathologic Processes, Lung Diseases, Fibrosing alveolitis, Interferon-gamma, Recombinant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), Stony Brook University, Philips Respironics
- Study start
- Jan 2007
- Primary completion
- 1 Jun 2010 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 26 Nov 2007 (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.
Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective treatment. Interferon-gamma is a medication that has been used for other lung diseases to decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not show any improvement in survival in patients with IPF. We hypothesize that giving interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in a way that decreases fibrosis.
Detailed description
Patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) will be enrolled in a phase I study of aerosol interferon-gamma (IFN-γ). Prior to initiation of treatment, patients will undergo CT of the chest, pulmonary function testing, and bronchoscopy with bronchoalveolar lavage. They will also undergo a lung deposition study to determine the lung dose of IFN-γ that will be delivered with each treatment. Patients will then receive aerosol IFN-γ 100mcg delivered three times weekly via nebulizer for one year. Study patients will be followed monthly to monitor potential side effects, vital signs, and progression of IPF symptoms. Labs will be drawn at regular intervals to monitor for side effects and to measure cytokine levels. Bronchoscopy will be performed at the 6 and/or 12 month visit to compare cytokine levels pre-, during, and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: aerosol interferon-gamma |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with IPF based on accepted criteria (see above) within 12 months prior to screening.
- Age 40-75.
- Absence of significant pulmonary hypertension as measured by right heart catheterization (mPAP ≥ 30 mmHG) or echocardiography (RVSP ≥ 50 mmHg).
- FVC ≥ 55% of predicted baseline value at screening; DLCO ≥ 30% predicted.
- PaO2 ≥ 65 mm Hg at rest on room air
Key exclusion criteria (17 listed)
- Six minute walk distance of < 200 meters.
- Patient unwilling or unable to undergo research bronchoscopy.
- Patient with known life threatening asthma or severe COPD.
- Patient requiring oxygen therapy for maintenance of adequate arterial oxygenation at rest.
- Patient with hypersensitivity to study medication or other component medication.
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 |
|---|---|---|
| aerosol interferon-gammaaerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year | Drug | A1 |
Primary outcome
safety, tolerability
Time frame: one year
1 secondary outcome
lung deposition of aerosolized IFN, bronchoalveolar lavage fluid levels of IFN and fibrotic cytokines pre-and post-treatment, pulmonary function testing trends during treatment, descriptive data regarding symptoms and clinical findings
Time frame: one year
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 28 Apr 2020.
- BackgroundGoldyn SR, Smaldone GC, Rom WN, Condos R. Safety Profile of Aerosol Interferon-gamma. Abstract submitted to American Thoracic Society for presentation at ATS annual meeting May 2008, Toronto.
- Derived from this study: PubMed 35667792Xue Y, Reddy SK, Garza LA. Toward Understanding Wound Immunology for High-Fidelity Skin Regeneration. Cold Spring Harb Perspect Biol. 2022 Jul 1;14(7):a041241. doi: 10.1101/cshperspect.a041241.
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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.
Rany Condos, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aerosol interferon-gamma in people with Pulmonary Fibrosis, run by NYU Langone Health 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 7 inclusion and 17 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 28 Apr 2020. 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 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?
safety, tolerability (time frame: one year). 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 NCT00563212, 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 28 Apr 2020.