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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL102225 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Baim Institute for Clinical Research | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to see whether a new investigational drug (Imatinib) may help improve asthma in people whose symptoms are not well controlled with high dose inhaled corticosteroid treatment.
Severe asthmatics remain poorly controlled despite high doses of standard asthma therapy or even daily doses of systemic corticosteroids or their equivalent. They account for a large proportion of the morbidity and mortality associated with asthma. Features that seem to characterize many patients with this disorder include persistent inflammation, symptoms, and airway hyperresponsiveness in the face of corticosteroid therapy. Mast cells are powerful, long-lived tissue dwelling effector cells that are resistant to corticosteroid effects and have been implicated in the pathobiology of asthma. Mast cells in the airway smooth muscle have been found to be the major distinguishing difference between asthmatic and non-asthmatic eosinophil airway disease; and putative circulating mast cell progenitors are increased 5 fold in asthma. Stem cell factor (SCF) is critical to mast cell homeostasis and upregulation and has pleiotropic effects on mast cells and eosinophils . SCF levels are elevated in relation to asthma severity and SCF antibodies block hyperresponsiveness and inflammation and remodeling in murine asthma models. Imatinib, a specific tyrosine kinase inhibitor, inhibits cKit (Kit), the receptor for SCF on mast cells. Imatinib at doses equivalent to, or below, doses safely used in humans, also mimics or exceeds anti-SCF effects in the murine asthma model. Therefore we would like to know Does imatinib, an inhibitor of Kit, ameliorate severe asthma, in association with effects on lung mast cell phenotype and/or function?
Specific Aims of the study are:
Specific Aim 1: To investigate whether, in patients with persistent airway responsiveness and poor asthma control despite intensive asthma therapy, 24 weeks of imatinib therapy results in a reduction in airway responsiveness and in secondary indicators of asthma control, airway inflammation, and structural changes in the airways.
Patients will be treated with imatinib in a randomized, double-blind, placebo controlled trial. Assessments will include methacholine and AMP reactivity, airway function, symptoms, airway wall thickness by CT scan, analysis of induced sputum, non-invasive markers of airway inflammation, and bronchoscopy including endobronchial biopsy and bronchoalveolar lavage - all before and at the end of therapy.
Specific Aim 2: To investigate whether, in patients with persistent airway responsiveness and poor asthma control despite intensive asthma therapy, 24 weeks of imatinib therapy results in changes in airway mast cell population and/or phenotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib mesylate | Active Comparator | Group on active imatinib treatment |
|
| Placebo | Placebo Comparator | Group on Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesylate | Drug | Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Methacholine Responsiveness as Assessed by the Provocation Concentration Causing a 20% Fall in Forced Expiratory Volume in One Second (FEV1) (PC20) at Month 3 and 6 Versus Baseline | Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups. PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1). | Over 6 months from beginning of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Tryptase | Change in serum total tryptase after 24 weeks of imatinib vs placebo treatment | 6 months after start of treatment |
| Bronchoalveolar Lavage (BAL) Fluid Tryptase Level | Change in BAL fluid tryptase levels after 24 weeks of imatinib vs. placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Israel, M.D | Brigham and Womens Hospital | Principal Investigator |
| Joshua Boyce, M.D | Brigham and Womens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Brigham and Womens Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15196279 | Background | Al-Muhsen SZ, Shablovsky G, Olivenstein R, Mazer B, Hamid Q. The expression of stem cell factor and c-kit receptor in human asthmatic airways. Clin Exp Allergy. 2004 Jun;34(6):911-6. doi: 10.1111/j.1365-2222.2004.01975.x. | |
| 1370529 | Background | Bischoff SC, Dahinden CA. c-kit ligand: a unique potentiator of mediator release by human lung mast cells. J Exp Med. 1992 Jan 1;175(1):237-44. doi: 10.1084/jem.175.1.237. |
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Following enrollment, 176 subjects entered a run-in period in which several inclusion criteria had to be met prior to randomization, including ACQ requirements and methacholine sensitivity, as well as safety and compliance requirements. 114 subjects who did not meet these inclusion criteria were not randomized.
Subjects were recruited from November 2010 until December 2014 in seven academic medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imatinib Mesylate | Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur. |
| FG001 | Placebo | Group on Placebo treatment Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
severe asthmatics ages 18-65
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| ID | Title | Description |
|---|---|---|
| BG000 | Imatinib Mesylate | Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Methacholine Responsiveness as Assessed by the Provocation Concentration Causing a 20% Fall in Forced Expiratory Volume in One Second (FEV1) (PC20) at Month 3 and 6 Versus Baseline | Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups. PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1). | Posted | Mean | Standard Deviation | Log2 Ratio | Over 6 months from beginning of treatment |
|
Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imatinib Mesylate | Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elliot Israel, MD | Brigham and Women's Hopsital | 617-732-8110 | eisrael@partners.org |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Not provided
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|
| Placebo | Drug | Placebo |
|
| 6 months after start of treatment |
| Change in Maximum Post-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) % | 6 months after start of treatment |
| Number of Asthma Exacerbations | Number of asthma exacerbations experienced from randomization to study completion. | Up to 24 weeks |
| FEV1 in Liters | Change in FEV1 in treatment group compared to placebo group | 6 months after start of treatment |
| FEV1% | Change in FEV1% of predicted | 6 months after start of treatment |
| Morning Peak Flow Measurement | Change in patient-reported morning peak flow measurement (L/s) | 6 months after start of treatment |
| Evening Peak Flow | Change in patient-reported evening peak flow measurement (L/s) | 6 months after start of treatment |
| Fractional Exhaled Nitric Oxide (FeNO) | Change in Fractional Exhaled Nitric Oxide Measurement (ppb) | 6 months after start of treatment |
| Asthma Control Questionnaire (ACQ) | Change in patient-reported ACQ score The six-item Asthma Control Questionnaire (ACQ-6) is a scale from 0 to 6 with a lower value denoting an improvement in asthma control. The minimal important difference is 0.5. | 6 months after start of treatment |
| Asthma Quality of Life Questionnaire (AQLQ) | Change in patient-reported Asthma Quality of Life Questionnaire (AQLQ) score The asthma quality of life questionnaire (AQLQ) is a 32-item scale with a range from 1-7 with a higher value denoting improvement. The minimal important difference is 0.5. | 6 months after start of treatment |
| Asthma Symptom Utility Index (ASUI) | Change in patient reported ASUI score The asthma symptom utility index (ASUI) is a 10-item weighted scale with a range from 0.2 to 1 with a higher value indicating improvement. The minimal important difference is 0.09. | 6 months after start of treatment |
| BAL Neutrophil % | Change in BAL neutrophil percentage from baseline | 6 months after start of treatment |
| BAL Eosinophil % | Change in BAL eosinophil percentage | 6 months after start of treatment |
| Bronchoalveolar Lavage (BAL) PGD2 | Change in bronchoalveolar lavage (BAL) PGD2 levels from baseline at 6 months | 6 months after start of treatment |
| Endobronchial Biopsy Total Tryptase-positive Mast Cells | Change in endobronchial biopsy total tryptase-positive mast cells from baseline at 6 months | 6 months after start of treatment |
| Endobronchial Biopsy Smooth Muscle Tryptase-positive Mast Cells | Change in the biopsy smooth muscle tryptase-positive mast cells from baseline at 6 months | 6 months after start of treatment |
| Blood Eosinophils | Change in blood eosinophil count | 6 months after start of treatment |
| Airway Wall Thickness | Change in airway wall thickness as assessed by computerized tomography (CT) | 6 months after start of treatment |
| Airway Wall Area | Change in airway wall area as assessed by computerized tomography (CT) | 6 months after start of treatment |
| Bronchoalveolar Lavage Histamine | Change in bronchoalveolar lavage histamine levels from baseline | 6 months after start of treatment |
| Urinary Prostaglandin D2 | Change in urinary Prostaglandin D2 levels from baseline | 6 months after start of treatment |
| Bronchoalveolar Lavage Cysteinyl Leukotrienes | Change in bronchoalveolar lavage cysteinyl leukotrienes levels from baseline | 6 months after start of treatment |
| Urinary Leukotriene E4 | Change in urinary leukotriene E4 levels from baseline | 6 months after start of treatment |
| Change in Sputum Supernatant Differential, Supernatant Tryptase and IL-13 | Change in sputum eosinophil and neutrophil percentage. Change in sputum supernatant tryptase as measured by ELISA. Change in sputum IL-13 level as measured by ELISA. | baseline to 24 weeks |
| Change in Inflammatory Mediators in Exhaled Breath Condensate | Assessment of change in eicosanoids in the exhaled breath condensate | baseline to week 24 |
| Change in Number of Self-Reported Asthma Symptom Free Days | baseline to week 24 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| 12037149 | Background | Brightling CE, Bradding P, Symon FA, Holgate ST, Wardlaw AJ, Pavord ID. Mast-cell infiltration of airway smooth muscle in asthma. N Engl J Med. 2002 May 30;346(22):1699-705. doi: 10.1056/NEJMoa012705. |
| 10233863 | Background | Campbell E, Hogaboam C, Lincoln P, Lukacs NW. Stem cell factor-induced airway hyperreactivity in allergic and normal mice. Am J Pathol. 1999 Apr;154(4):1259-65. doi: 10.1016/S0002-9440(10)65377-1. |
| 12149526 | Background | Carroll NG, Mutavdzic S, James AL. Increased mast cells and neutrophils in submucosal mucous glands and mucus plugging in patients with asthma. Thorax. 2002 Aug;57(8):677-82. doi: 10.1136/thorax.57.8.677. |
| 17872493 | Background | Flood-Page P, Swenson C, Faiferman I, Matthews J, Williams M, Brannick L, Robinson D, Wenzel S, Busse W, Hansel TT, Barnes NC; International Mepolizumab Study Group. A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1062-71. doi: 10.1164/rccm.200701-085OC. Epub 2007 Sep 13. |
| 11112161 | Background | Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. American Thoracic Society. Am J Respir Crit Care Med. 2000 Dec;162(6):2341-51. doi: 10.1164/ajrccm.162.6.ats9-00. No abstract available. |
| 8630386 | Background | Lukacs NW, Kunkel SL, Strieter RM, Evanoff HL, Kunkel RG, Key ML, Taub DD. The role of stem cell factor (c-kit ligand) and inflammatory cytokines in pulmonary mast cell activation. Blood. 1996 Mar 15;87(6):2262-8. |
| 19264687 | Background | Nair P, Pizzichini MM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, Hargreave FE, O'Byrne PM. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med. 2009 Mar 5;360(10):985-93. doi: 10.1056/NEJMoa0805435. |
| 16483568 | Background | Reber L, Da Silva CA, Frossard N. Stem cell factor and its receptor c-Kit as targets for inflammatory diseases. Eur J Pharmacol. 2006 Mar 8;533(1-3):327-40. doi: 10.1016/j.ejphar.2005.12.067. Epub 2006 Feb 17. |
| 9221761 | Background | Yuan Q, Austen KF, Friend DS, Heidtman M, Boyce JA. Human peripheral blood eosinophils express a functional c-kit receptor for stem cell factor that stimulates very late antigen 4 (VLA-4)-mediated cell adhesion to fibronectin and vascular cell adhesion molecule 1 (VCAM-1). J Exp Med. 1997 Jul 21;186(2):313-23. doi: 10.1084/jem.186.2.313. |
| 28514613 | Derived | Cahill KN, Katz HR, Cui J, Lai J, Kazani S, Crosby-Thompson A, Garofalo D, Castro M, Jarjour N, DiMango E, Erzurum S, Trevor JL, Shenoy K, Chinchilli VM, Wechsler ME, Laidlaw TM, Boyce JA, Israel E. KIT Inhibition by Imatinib in Patients with Severe Refractory Asthma. N Engl J Med. 2017 May 18;376(20):1911-1920. doi: 10.1056/NEJMoa1613125. |
| Withdrawal by Subject |
|
| Placebo |
Group on Placebo treatment Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group on active imatinib treatment
Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.
| OG001 | Placebo | Group on Placebo treatment Placebo: Placebo |
|
|
|
| Secondary | Serum Total Tryptase | Change in serum total tryptase after 24 weeks of imatinib vs placebo treatment | Posted | Mean | Standard Deviation | ng/ml | 6 months after start of treatment |
|
|
|
|
| Secondary | Bronchoalveolar Lavage (BAL) Fluid Tryptase Level | Change in BAL fluid tryptase levels after 24 weeks of imatinib vs. placebo | Posted | Mean | Standard Deviation | ng/mL | 6 months after start of treatment |
|
|
|
|
| Secondary | Change in Maximum Post-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) % | Posted | Mean | Standard Deviation | % of predicted | 6 months after start of treatment |
|
|
|
|
| Secondary | Number of Asthma Exacerbations | Number of asthma exacerbations experienced from randomization to study completion. | Posted | Number | events | Up to 24 weeks |
|
|
|
|
| Secondary | FEV1 in Liters | Change in FEV1 in treatment group compared to placebo group | Posted | Mean | 95% Confidence Interval | L | 6 months after start of treatment |
|
|
|
|
| Secondary | FEV1% | Change in FEV1% of predicted | Posted | Mean | Standard Deviation | % of predicted | 6 months after start of treatment |
|
|
|
|
| Secondary | Morning Peak Flow Measurement | Change in patient-reported morning peak flow measurement (L/s) | Posted | Mean | Standard Deviation | L/second | 6 months after start of treatment |
|
|
|
|
| Secondary | Evening Peak Flow | Change in patient-reported evening peak flow measurement (L/s) | Posted | Mean | Standard Deviation | L/second | 6 months after start of treatment |
|
|
|
|
| Secondary | Fractional Exhaled Nitric Oxide (FeNO) | Change in Fractional Exhaled Nitric Oxide Measurement (ppb) | Posted | Mean | Standard Deviation | parts per billion | 6 months after start of treatment |
|
|
|
|
| Secondary | Asthma Control Questionnaire (ACQ) | Change in patient-reported ACQ score The six-item Asthma Control Questionnaire (ACQ-6) is a scale from 0 to 6 with a lower value denoting an improvement in asthma control. The minimal important difference is 0.5. | Posted | Mean | Standard Deviation | units on a scale | 6 months after start of treatment |
|
|
|
|
| Secondary | Asthma Quality of Life Questionnaire (AQLQ) | Change in patient-reported Asthma Quality of Life Questionnaire (AQLQ) score The asthma quality of life questionnaire (AQLQ) is a 32-item scale with a range from 1-7 with a higher value denoting improvement. The minimal important difference is 0.5. | Posted | Mean | Standard Deviation | units on a scale | 6 months after start of treatment |
|
|
|
|
| Secondary | Asthma Symptom Utility Index (ASUI) | Change in patient reported ASUI score The asthma symptom utility index (ASUI) is a 10-item weighted scale with a range from 0.2 to 1 with a higher value indicating improvement. The minimal important difference is 0.09. | Posted | Mean | Standard Deviation | units on a scale | 6 months after start of treatment |
|
|
|
|
| Secondary | BAL Neutrophil % | Change in BAL neutrophil percentage from baseline | Posted | Mean | Standard Deviation | % neutrophils | 6 months after start of treatment |
|
|
|
|
| Secondary | BAL Eosinophil % | Change in BAL eosinophil percentage | Posted | Mean | Standard Deviation | % eosinophils | 6 months after start of treatment |
|
|
|
|
| Secondary | Bronchoalveolar Lavage (BAL) PGD2 | Change in bronchoalveolar lavage (BAL) PGD2 levels from baseline at 6 months | Posted | Mean | Standard Deviation | pg/mL | 6 months after start of treatment |
|
|
|
|
| Secondary | Endobronchial Biopsy Total Tryptase-positive Mast Cells | Change in endobronchial biopsy total tryptase-positive mast cells from baseline at 6 months | Posted | Mean | Standard Deviation | mast cells per mm2 | 6 months after start of treatment |
|
|
|
|
| Secondary | Endobronchial Biopsy Smooth Muscle Tryptase-positive Mast Cells | Change in the biopsy smooth muscle tryptase-positive mast cells from baseline at 6 months | Posted | Mean | Standard Deviation | mast cells per mm2 | 6 months after start of treatment |
|
|
|
|
| Secondary | Blood Eosinophils | Change in blood eosinophil count | Posted | Mean | Standard Deviation | eosinophils per microliter | 6 months after start of treatment |
|
|
|
|
| Secondary | Airway Wall Thickness | Change in airway wall thickness as assessed by computerized tomography (CT) | Posted | Mean | Standard Deviation | % of airway | 6 months after start of treatment |
|
|
|
|
| Secondary | Airway Wall Area | Change in airway wall area as assessed by computerized tomography (CT) | Posted | Mean | Standard Deviation | % of area | 6 months after start of treatment |
|
|
|
|
| Secondary | Bronchoalveolar Lavage Histamine | Change in bronchoalveolar lavage histamine levels from baseline | Posted | Mean | Standard Deviation | nM | 6 months after start of treatment |
|
|
|
|
| Secondary | Urinary Prostaglandin D2 | Change in urinary Prostaglandin D2 levels from baseline | Posted | Mean | Standard Deviation | ng/mg Creatinine | 6 months after start of treatment |
|
|
|
|
| Secondary | Bronchoalveolar Lavage Cysteinyl Leukotrienes | Change in bronchoalveolar lavage cysteinyl leukotrienes levels from baseline | Posted | Mean | Standard Deviation | pg/mL | 6 months after start of treatment |
|
|
|
|
| Secondary | Urinary Leukotriene E4 | Change in urinary leukotriene E4 levels from baseline | Posted | Mean | Standard Deviation | ng/mg Creatinine | 6 months after start of treatment |
|
|
|
|
| Secondary | Change in Sputum Supernatant Differential, Supernatant Tryptase and IL-13 | Change in sputum eosinophil and neutrophil percentage. Change in sputum supernatant tryptase as measured by ELISA. Change in sputum IL-13 level as measured by ELISA. | Sputum sample slide preparation quality was poor and samples meeting quality control were insufficient for analysis of sputum differential. Insufficient study funds prevented assessment of sputum tryptase. IL-13 was below the detection limit of assay in sputum supernatant. | Posted | baseline to 24 weeks |
|
|
| Secondary | Change in Inflammatory Mediators in Exhaled Breath Condensate | Assessment of change in eicosanoids in the exhaled breath condensate | The exhaled breath condensate was not processed for inflammatory mediators. | Posted | baseline to week 24 |
|
|
| Secondary | Change in Number of Self-Reported Asthma Symptom Free Days | Self-reported asthma symptom free days were not entered into the study database. | Posted | baseline to week 24 |
|
|
| 3 |
| 32 |
| 29 |
| 32 |
| EG001 | Placebo | Group on Placebo treatment Placebo: Placebo | 5 | 30 | 23 | 30 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leg Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Acute URI | Infections and infestations | Systematic Assessment |
|
| Ankle Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Angioedemia | Immune system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Abnormal LFTs | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
|
| Back/Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |