Idiopathic Pulmonary FibrosisPhase 3NCT00075998
The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study testing Interferon gamma-1b ("Actimmune") in people with Idiopathic Pulmonary Fibrosis and Lung Disease, run by InterMune at 1 site in United States.
Trial summary
Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF Enrollment: Approximately 800 patients will be enrolled from approximately 80… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Lung Disease, Pulmonary Fibrosis
- What is being tested?
- Interferon gamma-1b ("Actimmune")
- How many people
- 826 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to May 2007
- Phase
- Phase 3
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms consistent with IPF of >= 3 months duration
- Diagnosis of IPF within 48 months before randomization
- Age 40 through 79, inclusive
- High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient.
- For patients aged < 50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP within 48 months before randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage (BAL) if performed.
- For patients aged < 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months before randomization:
Show all 18Show fewer
- Open or VATS lung biopsy showing definite or probable UIP
- Transbronchial biopsy showing no features to support an alternative diagnosis
- BAL showing no features to support an alternative diagnosis IPF Disease Severity and Progression
- FVC >= 55% of predicted value (post administration of bronchodilator)
- Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon monoxide transfer capacity (DLCO/TLCO) >= 35% of predicted value
- At least one of either FVC or Hb-corrected DLCO/TLCO <= 90% of predicted value
- IPF disease progression evidenced by one or more of the following within the past year and the absence of evidence of improvement in the past year:
- Absolute decrease of >= 10% in FVC
- Absolute decrease of >= 15% in DLCO/TLCO
- Evidence of clinically significant worsening on chest X ray or HRCT
- Significant worsening of dyspnea
- Distance walked >= 150 meters (492 feet) with O2 saturation >= 83% on <= 6 L/min of O2 during the 6 Minute Walk Test (6MWT) oxygen titration procedure
Who cannot join
- Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Principal Investigator (PI)
- Forced expiratory volume in the first second (FEV1)/FVC ratio < 0.6 (after administration of bronchodilator)
- Residual volume (RV) > 140% of predicted (before administration of bronchodilator)
- History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
- Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, and cancer
- Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
Show all 41Show fewer
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis
- On a lung transplantation waiting list at time of randomization
- Medical Exclusions:
- Any history of malignancy likely to result in death, significant disability, or likely to require significant medical or surgical intervention within the next 3 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
- Any condition other than IPF which, in the opinion of the PI, is likely to result in the death of the patient within the next 3 years
- History of unstable or deteriorating cardiac, vascular, or neurologic disease within the previous 6 months, including but not limited to the following:
- Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty
- Congestive heart failure requiring hospitalization
- Uncontrolled arrhythmias
- Thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism)
- Transient ischemic attacks (TIAs) or cerebral vascular accident
- Any condition, which, in the opinion of the investigator, might be significantly exacerbated by the known side effects, (e.g., flu-like syndrome) associated with the administration of IFN g 1b
- History of any of the following medical conditions:
- Multiple sclerosis
- Seizures within the past 10 years or taking anti seizure medication
- Severe or poorly controlled diabetes
- Pregnancy or lactation. Females of childbearing potential are required to have a negative serum pregnancy test before treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
- Inability to tolerate nonsteroidal anti-inflammatory drugs (NSAIDS) or acetaminophen (paracetamol)
- History of ethanol abuse in the past 2 years
- Known hypersensitivity to IFN-g or closely related interferons or to any component of the study treatment
- Presence of human immunodeficiency virus (HIV) or chronic viral hepatitis
- Laboratory Exclusions:
- Any of the following liver function test criteria above specified limits:
- Total bilirubin > 1.5 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) > 2 x ULN; alkaline phosphatase > 2 x ULN; or albumin < 3.0 mg/dL
- Any of the following hematology test criteria outside of specified limits: WBC < 2,500/mm3, hematocrit < 30% or > 59%, platelets < 100,000 /mm3
- Creatinine > 1.5 x ULN
- Concomitant Therapy Exclusions:
- Prednisone therapy (prednisone or equivalent, with dose adjusted for potency) in excess of 0.125 mg/kg ideal body weight (IBW) per day or in excess of 0.25 mg/kg IBW every other day. Patients will also be excluded if they were not on a stable dose of corticosteroid therapy for at least 28 days prior to screening.
- Prior treatment with IFN g 1b
- Investigational therapy (i.e., agents that are not approved by local regulatory agencies) for any indication within 28 days prior to screening
- The following therapies are excluded within 28 days prior to screening:
- Investigational therapy for IPF, including pirfenidone
- Any cytotoxic/immunosuppressive agent other than corticosteroids (including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine)
- Any cytokine modulators (including but not limited to etanercept, infliximab)
- Any therapy targeted to treat IPF (including but not limited to d penicillamine, colchicine, bosentan, N-acetyl-cysteine [NAC])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)
- Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF
- Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe
- Randomization: 2:1 active-to-placebo ratio
- Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)
Read the detailed description
INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, has now completed enrolling patients with mild to moderate IPF. Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years.
- Being tested
- Interferon gamma-1b ("Actimmune")
- Keywords
- Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Interferon, Gamma, Actimmune, INSPIRE, InterMune
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Pulmonary Fibrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma-1b ("Actimmune")Drug
200 mcg, SQ, 3x per week
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status.
Measured: 3.5 years
Secondary outcomes (3)
Lung transplant-free survival time (ongoing assessment up to end of study).
Measured: 3.5 years
Total number of days without hospitalization resulting from respiratory admission diagnosis (ongoing assessment up to end of study).
Measured: 3.5 years
Changes from baseline measurement to week 96 measurement in the following (measured every 24 weeks): 6-minute walk test, shortness of breath
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2004 (estimated)
- Study startDec 2003
- Study completionMay 2007
Why it stopped: test drug showed lack of benefit at interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- InterMune, Inc., Study chair, Medical Information
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075998
- Sponsor's protocol ID
- GIPF-007
- Status last verified
- Jul 2009
- First submitted
- 12 Jan 2004
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wells AU, Jacob J, Sverzellati N, Cross G, Barnett J, De Lauretis A, Antoniou K, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. A formula for predicting emphysema extent in combined idiopathic pulmonary fibrosis and emphysema. Respir Res. 2024 Jan 18;25(1):33. doi: 10.1186/s12931-023-02589-x.
PubMed 38238788Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
PubMed 35688625Kreuter M, Lee JS, Tzouvelekis A, Oldham JM, Molyneaux PL, Weycker D, Atwood M, Kirchgaessler KU, Maher TM. Monocyte Count as a Prognostic Biomarker in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2021 Jul 1;204(1):74-81. doi: 10.1164/rccm.202003-0669OC.
PubMed 33434107Kreuter M, Lederer DJ, Molina-Molina M, Noth I, Valenzuela C, Frankenstein L, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. Association of Angiotensin Modulators With the Course of Idiopathic Pulmonary Fibrosis. Chest. 2019 Oct;156(4):706-714. doi: 10.1016/j.chest.2019.04.015. Epub 2019 Apr 29.
PubMed 31047956Cottin V, Hansell DM, Sverzellati N, Weycker D, Antoniou KM, Atwood M, Oster G, Kirchgaessler KU, Collard HR, Wells AU. Effect of Emphysema Extent on Serial Lung Function in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1162-1171. doi: 10.1164/rccm.201612-2492OC.
PubMed 28657784du Bois RM, Albera C, Bradford WZ, Costabel U, Leff JA, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. 6-Minute walk distance is an independent predictor of mortality in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2014 May;43(5):1421-9. doi: 10.1183/09031936.00131813. Epub 2013 Dec 5.
PubMed 24311766King TE Jr, Albera C, Bradford WZ, Costabel U, Hormel P, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, du Bois RM; INSPIRE Study Group. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial. Lancet. 2009 Jul 18;374(9685):222-8. doi: 10.1016/S0140-6736(09)60551-1. Epub 2009 Jun 29.
PubMed 19570573
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)
- ClinicalTrials.gov ID
- NCT00075998
- Acronym / sponsor ID
- GIPF-007
- Keywords
- Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Interferon, Gamma, Actimmune
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: test drug showed lack of benefit at interim analysis
- Enrolment
- 826 participants (actual)
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- May 2007 (actual)
- First posted
- 14 Jan 2004 (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.
- Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF
- Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe
- Randomization: 2:1 active-to-placebo ratio
- Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)
Detailed description
INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, has now completed enrolling patients with mild to moderate IPF. Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Clinical symptoms consistent with IPF of >= 3 months duration
- Diagnosis of IPF within 48 months before randomization
- Age 40 through 79, inclusive
- High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient.
- For patients aged < 50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP within 48 months before randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage (BAL) if performed.
Key exclusion criteria (41 listed)
- Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Principal Investigator (PI)
- Forced expiratory volume in the first second (FEV1)/FVC ratio < 0.6 (after administration of bronchodilator)
- Residual volume (RV) > 140% of predicted (before administration of bronchodilator)
- History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
- Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, and 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 |
|---|---|---|
| Interferon gamma-1b ("Actimmune")200 mcg, SQ, 3x per week | Drug | – |
Primary outcome
Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status.
Time frame: 3.5 years
3 secondary outcomes
Lung transplant-free survival time (ongoing assessment up to end of study).
Time frame: 3.5 years
Total number of days without hospitalization resulting from respiratory admission diagnosis (ongoing assessment up to end of study).
Time frame: 3.5 years
Changes from baseline measurement to week 96 measurement in the following (measured every 24 weeks): 6-minute walk test, shortness of breath
Time frame: 96 weeks
Results and safety
The study was stopped early (reason given: test drug showed lack of benefit at interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
- Derived from this study: PubMed 38238788Wells AU, Jacob J, Sverzellati N, Cross G, Barnett J, De Lauretis A, Antoniou K, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. A formula for predicting emphysema extent in combined idiopathic pulmonary fibrosis and emphysema. Respir Res. 2024 Jan 18;25(1):33. doi: 10.1186/s12931-023-02589-x.
- Derived from this study: PubMed 35688625Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
- Derived from this study: PubMed 33434107Kreuter M, Lee JS, Tzouvelekis A, Oldham JM, Molyneaux PL, Weycker D, Atwood M, Kirchgaessler KU, Maher TM. Monocyte Count as a Prognostic Biomarker in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2021 Jul 1;204(1):74-81. doi: 10.1164/rccm.202003-0669OC.
- Derived from this study: PubMed 31047956Kreuter M, Lederer DJ, Molina-Molina M, Noth I, Valenzuela C, Frankenstein L, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. Association of Angiotensin Modulators With the Course of Idiopathic Pulmonary Fibrosis. Chest. 2019 Oct;156(4):706-714. doi: 10.1016/j.chest.2019.04.015. Epub 2019 Apr 29.
- Derived from this study: PubMed 28657784Cottin V, Hansell DM, Sverzellati N, Weycker D, Antoniou KM, Atwood M, Oster G, Kirchgaessler KU, Collard HR, Wells AU. Effect of Emphysema Extent on Serial Lung Function in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1162-1171. doi: 10.1164/rccm.201612-2492OC.
- Derived from this study: PubMed 24311766du Bois RM, Albera C, Bradford WZ, Costabel U, Leff JA, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. 6-Minute walk distance is an independent predictor of mortality in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2014 May;43(5):1421-9. doi: 10.1183/09031936.00131813. Epub 2013 Dec 5.
- Derived from this study: PubMed 19570573King TE Jr, Albera C, Bradford WZ, Costabel U, Hormel P, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, du Bois RM; INSPIRE Study Group. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial. Lancet. 2009 Jul 18;374(9685):222-8. doi: 10.1016/S0140-6736(09)60551-1. Epub 2009 Jun 29.
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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.
InterMune, Inc. study chair
Medical Information
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon gamma-1b ("Actimmune") in people with Idiopathic Pulmonary Fibrosis and Lung Disease, run by InterMune 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 18 inclusion and 41 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 2 Jul 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: test drug showed lack of benefit at interim analysis). Results are not available in the source record.
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?
Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status. (time frame: 3.5 years). 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 NCT00075998, which also lists 7 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 2 Jul 2009.