Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation
NCT ID: NCT03513471
Last Updated: 2021-05-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE1/PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2019-08-09
Study Completion Date
2021-12-31
Brief Summary
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Purpose: The primary objective of this study is to examine the effectiveness of anakinra as a rescue treatment for allergic airway inflammation. Utilizing an inhaled allergen challenge model, the investigators will determine the effectiveness of a single 1 mg/kg dose of anakinra administered after inhaled allergen challenge for mitigating features of airway inflammation.
Participants: 12 mild allergic asthmatics sensitized to Dermatophagoides farinae (D. farinae)
Procedures (methods): Eligible subjects will participate in a double blind cross-over study. Following randomization to the placebo or anakinra treatment group, subjects will undergo inhalation of D. farinae, and their early and late phase asthmatic responses will be measured. Subjects will undergo induced sputum sampling, methacholine challenge, and mucociliary clearance measures. After completion of period 1, subjects will cross over to the alternate study arm.
Participants: 12 mild allergic asthmatics sensitized to Dermatophagoides farinae (D. farinae)
Procedures (methods): Eligible subjects will participate in a double blind cross-over study. Following randomization to the placebo or anakinra treatment group, subjects will undergo inhalation of D. farinae, and their early and late phase asthmatic responses will be measured. Subjects will undergo induced sputum sampling, methacholine challenge, and mucociliary clearance measures. After completion of period 1, subjects will cross over to the alternate study arm.
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Detailed Description
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Asthma is an increasingly common chronic illness with higher rates of hospitalization for exacerbation than many other chronic conditions. In 2009, total asthma costs in the U.S. were estimated at $56 billion per year, and over half the overall asthma-related costs were attributed to inpatient hospitalization. Allergen exposure and viral infection are among the most common triggers for asthma exacerbations. Exacerbations of allergic asthma are characterized by an early phase response (EPR), mediated by release of preformed mediators like histamine from mast cells, and a late phase response (LPR) 3-7 hours later mediated by chemokines and cytokines, including IL-1β, that attract leukocytes such as neutrophils and eosinophils to the airways, increase mucus production, trigger airway smooth muscle contraction, and result in airway constriction and airway hyper-reactivity (AHR). The LPR is thought to be predominantly responsible for the symptoms associated with acute exacerbations of allergic asthma.
While corticosteroids are considered a mainstay of treatment for asthma exacerbation regardless of the trigger, there are limitations to their effectiveness in the acute setting including the initial lag period of 4-6 hours or more before therapeutic effect and the concern for broad immune suppression. Corticosteroids are often ineffective in treating the neutrophilic component of airway inflammation seen with viral infection and allergen-induced airway inflammation. Finally, mucus plugging is a known hallmark of severe and fatal asthma, yet there is a notable lack of effective mucolytic treatments for asthma. Time to therapeutic benefit is key in preventing patient morbidity and mortality. Currently there is an urgent need for anti-inflammatory treatments that work quickly and effectively in acute asthma exacerbations.
The investigators propose that IL-1 blockade can achieve these ends and perhaps complement corticosteroid actions. Anakinra is an FDA-approved recombinant form of human IL-1 receptor antagonist (IL-1RA), a natural anti-inflammatory cytokine that competes with agonist binding to the IL-1 receptor, suppressing IL-1β and IL-1a signaling. IL-1 signaling mediates key features of viral- and allergen-induced airway inflammation. Previous studies in animal and in vitro models demonstrate that IL-1 signaling can directly impact three aspects of an airway inflammatory response: granulocyte (neutrophil/eosinophil) recruitment; non-specific and allergen-specific airway reactivity; and mucin production. Numerous IL-1 blocking agents are FDA-approved for conditions where the IL-1β pathway predominates disease pathophysiology, such as in systemic juvenile idiopathic arthritis and the cryopyrin-associated periodic syndromes.
Anakinra is an ideal candidate to test as a rescue treatment for acute asthma exacerbation due to its fast onset of action (reaching peak concentrations in 3-7 hours), and a short 4-6 hour half-life. A single 1mg/kg dose (up to 100mg) of anakinra or placebo will be administered at the onset of the EPR to model anakinra use in an emergency care setting. This dose was chosen because it is the current FDA-approved dose for rheumatoid arthritis (RA). Notably, the investigators have previously demonstrated that a 1 mg/kg dose resulted in significant reduction in airway granulocyte recruitment following lipopolysaccharide (LPS) challenge in a study of healthy volunteers. The investigators' objective is to determine if a single 1 mg/kg dose of Anakinra can mitigate key features of asthma exacerbations, namely AHR, airway constriction, airway inflammation, and mucous secretion/clearance.
While corticosteroids are considered a mainstay of treatment for asthma exacerbation regardless of the trigger, there are limitations to their effectiveness in the acute setting including the initial lag period of 4-6 hours or more before therapeutic effect and the concern for broad immune suppression. Corticosteroids are often ineffective in treating the neutrophilic component of airway inflammation seen with viral infection and allergen-induced airway inflammation. Finally, mucus plugging is a known hallmark of severe and fatal asthma, yet there is a notable lack of effective mucolytic treatments for asthma. Time to therapeutic benefit is key in preventing patient morbidity and mortality. Currently there is an urgent need for anti-inflammatory treatments that work quickly and effectively in acute asthma exacerbations.
The investigators propose that IL-1 blockade can achieve these ends and perhaps complement corticosteroid actions. Anakinra is an FDA-approved recombinant form of human IL-1 receptor antagonist (IL-1RA), a natural anti-inflammatory cytokine that competes with agonist binding to the IL-1 receptor, suppressing IL-1β and IL-1a signaling. IL-1 signaling mediates key features of viral- and allergen-induced airway inflammation. Previous studies in animal and in vitro models demonstrate that IL-1 signaling can directly impact three aspects of an airway inflammatory response: granulocyte (neutrophil/eosinophil) recruitment; non-specific and allergen-specific airway reactivity; and mucin production. Numerous IL-1 blocking agents are FDA-approved for conditions where the IL-1β pathway predominates disease pathophysiology, such as in systemic juvenile idiopathic arthritis and the cryopyrin-associated periodic syndromes.
Anakinra is an ideal candidate to test as a rescue treatment for acute asthma exacerbation due to its fast onset of action (reaching peak concentrations in 3-7 hours), and a short 4-6 hour half-life. A single 1mg/kg dose (up to 100mg) of anakinra or placebo will be administered at the onset of the EPR to model anakinra use in an emergency care setting. This dose was chosen because it is the current FDA-approved dose for rheumatoid arthritis (RA). Notably, the investigators have previously demonstrated that a 1 mg/kg dose resulted in significant reduction in airway granulocyte recruitment following lipopolysaccharide (LPS) challenge in a study of healthy volunteers. The investigators' objective is to determine if a single 1 mg/kg dose of Anakinra can mitigate key features of asthma exacerbations, namely AHR, airway constriction, airway inflammation, and mucous secretion/clearance.
Conditions
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Asthma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Study subjects will be randomized to one of two arms, either receiving Anakinra or placebo, then having a washout period and receiving the opposite treatment.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
The randomization will be done by the department biostatistician and communicated with Investigational Drug Services so the experiment will remain blinded.
Study Groups
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Anakinra then Placebo Treatment
Subjects randomized to this arm will receive the experimental treatment of Anakinra on their first exposure to the Dermatophagoides Farinae (dust mite) allergen challenge, followed by the Anakinra matching placebo on their second exposure.
Group Type
EXPERIMENTAL
Anakinra
Intervention Type
BIOLOGICAL
A single 1mg/kg subcutaneous injection (up to 100mg) of anakinra will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
Anakinra Matching Placebo
Intervention Type
OTHER
A single dose of matching placebo will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
Dermatophagoides Farinae
Intervention Type
DRUG
Standardized house dust mite Dermatophagoides farinae (D. farinae) allergen extract at 30,000 allergen units (AU)/mL for inhalation (provided by Greer Laboratories, Lenoir, NC).
Placebo then Anakinra Treatment
Subjects randomized to this arm will receive the inactive placebo on their first exposure to the Dust Mite Allergen challenge, followed by the experimental treatment of Anakinra on their second exposure.
Group Type
EXPERIMENTAL
Anakinra
Intervention Type
BIOLOGICAL
A single 1mg/kg subcutaneous injection (up to 100mg) of anakinra will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
Anakinra Matching Placebo
Intervention Type
OTHER
A single dose of matching placebo will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
Dermatophagoides Farinae
Intervention Type
DRUG
Standardized house dust mite Dermatophagoides farinae (D. farinae) allergen extract at 30,000 allergen units (AU)/mL for inhalation (provided by Greer Laboratories, Lenoir, NC).
Interventions
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Anakinra
A single 1mg/kg subcutaneous injection (up to 100mg) of anakinra will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
Intervention Type
BIOLOGICAL
Anakinra Matching Placebo
A single dose of matching placebo will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
Intervention Type
OTHER
Dermatophagoides Farinae
Standardized house dust mite Dermatophagoides farinae (D. farinae) allergen extract at 30,000 allergen units (AU)/mL for inhalation (provided by Greer Laboratories, Lenoir, NC).
Intervention Type
DRUG
Other Intervention Names
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Kinaret
dummy
Allergen extract
Eligibility Criteria
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Inclusion Criteria
* Age range 18-45 years, inclusive
* FEV1 of at least 80% of predicted and FEV1/FVC (Forced expiratory volume in one second/forced vital capacity) ratio of at least 0.7 (without use of bronchodilator medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.
* Physician diagnosis of asthma
* Positive methacholine inhalation challenge as performed in the separate screening protocol within the prior 12 months (defined as provocative concentration of methacholine of 10 mg/mL or less producing a 20% fall in FEV1 (PC20 methacholine)
* Allergic sensitization to house dust mite (D. farinae) as confirmed by positive immediate skin prick test response
* Clinical reactivity to D. farinae assessed through inhaled allergen challenge with a decline in FEV1 of ≥20% from baseline in the early asthmatic response and ≥15% in the late asthmatic response.
* Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more.
* Oxygen saturation of \>94% and blood pressure within the following limits: (Systolic between 150-90 mmHg, Diastolic between 90-60 mmHg).
* Ability to provide an induced sputum sample.
* Negative intracutaneous tuberculin skin test (PPD) defined as less than 5mm induration for the purpose of this protocol (positive PPD contraindication to anakinra injection). A negative tuberculosis (TB) test within the past year (either PPD or quantiferon TB Gold) is also acceptable
* FEV1 of at least 80% of predicted and FEV1/FVC (Forced expiratory volume in one second/forced vital capacity) ratio of at least 0.7 (without use of bronchodilator medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.
* Physician diagnosis of asthma
* Positive methacholine inhalation challenge as performed in the separate screening protocol within the prior 12 months (defined as provocative concentration of methacholine of 10 mg/mL or less producing a 20% fall in FEV1 (PC20 methacholine)
* Allergic sensitization to house dust mite (D. farinae) as confirmed by positive immediate skin prick test response
* Clinical reactivity to D. farinae assessed through inhaled allergen challenge with a decline in FEV1 of ≥20% from baseline in the early asthmatic response and ≥15% in the late asthmatic response.
* Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more.
* Oxygen saturation of \>94% and blood pressure within the following limits: (Systolic between 150-90 mmHg, Diastolic between 90-60 mmHg).
* Ability to provide an induced sputum sample.
* Negative intracutaneous tuberculin skin test (PPD) defined as less than 5mm induration for the purpose of this protocol (positive PPD contraindication to anakinra injection). A negative tuberculosis (TB) test within the past year (either PPD or quantiferon TB Gold) is also acceptable
Exclusion Criteria
Clinical contraindications:
* Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections or immunodeficiency.
* Pregnancy or nursing a baby
* History of latex allergy/sensitivity
* Allergy/sensitivity to anakinra or its formulation
* Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
* Exacerbation of asthma more than 2x/week which could be characteristics of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
* Daily requirements for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma (not to include prophylactic use of albuterol prior to exercise).
* Viral upper respiratory tract infection within 4 weeks of challenge.
* Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
* Severe asthma
* Mental illness of history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
* Cigarette smoking \>1 pack per month
* Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
* Allergy/sensitivity to study drugs or their formulations
* Known hypersensitivity to methacholine or to other parasympathomimetic agents
* History of intubation for asthma
* Unwillingness to limit coffee, tea, cola drinks, chocolate, or other foods containing caffeine after midnight on the days that methacholine challenge testing and inhaled allergen challenge is to be performed
* Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
* Radiation history will be collected. Any subject whose exposure history within the past twelve months would cause them to exceed their annual limits will be excluded
Usage of the following medications:
* Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
* Subjects who are prescribed daily inhaled corticosteroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirlukast) will be required to discontinue these medications at least 4 weeks prior to their screening visit.
* Use of daily theophylline within the past month.
* Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
* Use of any immunosuppressant therapy within the preceding 12 months will be reviewed by the study physician.
* Use of any immunomodulatory therapy within the preceding 12 months.
* Use of beta blocking medications
* Antihistamines in the 5 days prior to allergen challenge
* Routine use of NSAIDs, including aspirin.
Physical/laboratory indications:
* Abnormalities on lung auscultation
* Temperature \>37.8 C
* Oxygen saturation of \<94%
* Systolic BP\>150 mmHg or \<90 mmHg or diastolic BP\>90 mmHg or \<60 mmHg
* Absolute neutrophil count \<1.4 x 109/L
Inability or unwillingness of a participant to give written informed consent
* Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections or immunodeficiency.
* Pregnancy or nursing a baby
* History of latex allergy/sensitivity
* Allergy/sensitivity to anakinra or its formulation
* Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
* Exacerbation of asthma more than 2x/week which could be characteristics of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
* Daily requirements for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma (not to include prophylactic use of albuterol prior to exercise).
* Viral upper respiratory tract infection within 4 weeks of challenge.
* Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
* Severe asthma
* Mental illness of history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
* Cigarette smoking \>1 pack per month
* Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
* Allergy/sensitivity to study drugs or their formulations
* Known hypersensitivity to methacholine or to other parasympathomimetic agents
* History of intubation for asthma
* Unwillingness to limit coffee, tea, cola drinks, chocolate, or other foods containing caffeine after midnight on the days that methacholine challenge testing and inhaled allergen challenge is to be performed
* Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
* Radiation history will be collected. Any subject whose exposure history within the past twelve months would cause them to exceed their annual limits will be excluded
Usage of the following medications:
* Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
* Subjects who are prescribed daily inhaled corticosteroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirlukast) will be required to discontinue these medications at least 4 weeks prior to their screening visit.
* Use of daily theophylline within the past month.
* Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
* Use of any immunosuppressant therapy within the preceding 12 months will be reviewed by the study physician.
* Use of any immunomodulatory therapy within the preceding 12 months.
* Use of beta blocking medications
* Antihistamines in the 5 days prior to allergen challenge
* Routine use of NSAIDs, including aspirin.
Physical/laboratory indications:
* Abnormalities on lung auscultation
* Temperature \>37.8 C
* Oxygen saturation of \<94%
* Systolic BP\>150 mmHg or \<90 mmHg or diastolic BP\>90 mmHg or \<60 mmHg
* Absolute neutrophil count \<1.4 x 109/L
Inability or unwillingness of a participant to give written informed consent
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michelle Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
References
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Moorman JE, Akinbami LJ, Bailey CM, Zahran HS, King ME, Johnson CA, Liu X. National surveillance of asthma: United States, 2001-2010. Vital Health Stat 3. 2012 Nov;(35):1-58.
Reference Type
BACKGROUND
Kaur BP, Lahewala S, Arora S, Agnihotri K, Panaich SS, Secord E, Levine D. Asthma: Hospitalization Trends and Predictors of In-Hospital Mortality and Hospitalization Costs in the USA (2001-2010). Int Arch Allergy Immunol. 2015;168(2):71-8. doi: 10.1159/000441687. Epub 2015 Nov 24.
Reference Type
BACKGROUND
Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, FitzGerald JM. Economic burden of asthma: a systematic review. BMC Pulm Med. 2009 May 19;9:24. doi: 10.1186/1471-2466-9-24.
Reference Type
BACKGROUND
Hasegawa K, Tsugawa Y, Brown DF, Camargo CA Jr. Childhood asthma hospitalizations in the United States, 2000-2009. J Pediatr. 2013 Oct;163(4):1127-33.e3. doi: 10.1016/j.jpeds.2013.05.002. Epub 2013 Jun 12.
Reference Type
BACKGROUND
Jackson DJ, Sykes A, Mallia P, Johnston SL. Asthma exacerbations: origin, effect, and prevention. J Allergy Clin Immunol. 2011 Dec;128(6):1165-74. doi: 10.1016/j.jaci.2011.10.024.
Reference Type
BACKGROUND
Stoppelenburg AJ, Salimi V, Hennus M, Plantinga M, Huis in 't Veld R, Walk J, Meerding J, Coenjaerts F, Bont L, Boes M. Local IL-17A potentiates early neutrophil recruitment to the respiratory tract during severe RSV infection. PLoS One. 2013 Oct 23;8(10):e78461. doi: 10.1371/journal.pone.0078461. eCollection 2013.
Reference Type
BACKGROUND
Zhu J, Message SD, Qiu Y, Mallia P, Kebadze T, Contoli M, Ward CK, Barnathan ES, Mascelli MA, Kon OM, Papi A, Stanciu LA, Jeffery PK, Johnston SL. Airway inflammation and illness severity in response to experimental rhinovirus infection in asthma. Chest. 2014 Jun;145(6):1219-1229. doi: 10.1378/chest.13-1567.
Reference Type
BACKGROUND
Grunberg K, Smits HH, Timmers MC, de Klerk EP, Dolhain RJ, Dick EC, Hiemstra PS, Sterk PJ. Experimental rhinovirus 16 infection. Effects on cell differentials and soluble markers in sputum in asthmatic subjects. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):609-16. doi: 10.1164/ajrccm.156.2.9610079.
Reference Type
BACKGROUND
Nagarkar DR, Bowman ER, Schneider D, Wang Q, Shim J, Zhao Y, Linn MJ, McHenry CL, Gosangi B, Bentley JK, Tsai WC, Sajjan US, Lukacs NW, Hershenson MB. Rhinovirus infection of allergen-sensitized and -challenged mice induces eotaxin release from functionally polarized macrophages. J Immunol. 2010 Aug 15;185(4):2525-35. doi: 10.4049/jimmunol.1000286. Epub 2010 Jul 19.
Reference Type
BACKGROUND
Fanta CH, Rossing TH, McFadden ER Jr. Glucocorticoids in acute asthma. A critical controlled trial. Am J Med. 1983 May;74(5):845-51. doi: 10.1016/0002-9343(83)91076-8.
Reference Type
BACKGROUND
Ellul-Micallef R. The acute effects of corticosteroids in bronchial asthma. Eur J Respir Dis Suppl. 1982;122:118-25.
Reference Type
BACKGROUND
Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8.
Reference Type
BACKGROUND
Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticosteroids. Rev Infect Dis. 1989 Nov-Dec;11(6):954-63. doi: 10.1093/clinids/11.6.954.
Reference Type
BACKGROUND
Ulich TR, Yin SM, Guo KZ, del Castillo J, Eisenberg SP, Thompson RC. The intratracheal administration of endotoxin and cytokines. III. The interleukin-1 (IL-1) receptor antagonist inhibits endotoxin- and IL-1-induced acute inflammation. Am J Pathol. 1991 Mar;138(3):521-4.
Reference Type
BACKGROUND
Hudock KM, Liu Y, Mei J, Marino RC, Hale JE, Dai N, Worthen GS. Delayed resolution of lung inflammation in Il-1rn-/- mice reflects elevated IL-17A/granulocyte colony-stimulating factor expression. Am J Respir Cell Mol Biol. 2012 Oct;47(4):436-44. doi: 10.1165/rcmb.2012-0104OC. Epub 2012 May 16.
Reference Type
BACKGROUND
Tsukagoshi H, Sakamoto T, Xu W, Barnes PJ, Chung KF. Effect of interleukin-1 beta on airway hyperresponsiveness and inflammation in sensitized and nonsensitized Brown-Norway rats. J Allergy Clin Immunol. 1994 Feb;93(2):464-9. doi: 10.1016/0091-6749(94)90355-7.
Reference Type
BACKGROUND
Barchasz E, Naline E, Molimard M, Moreau J, Georges O, Emonds-Alt X, Advenier C. Interleukin-1beta-induced hyperresponsiveness to [Sar9,Met(O2)11]substance P in isolated human bronchi. Eur J Pharmacol. 1999 Aug 20;379(1):87-95. doi: 10.1016/s0014-2999(99)00484-7.
Reference Type
BACKGROUND
Wang CC, Fu CL, Yang YH, Lo YC, Wang LC, Chuang YH, Chang DM, Chiang BL. Adenovirus expressing interleukin-1 receptor antagonist alleviates allergic airway inflammation in a murine model of asthma. Gene Ther. 2006 Oct;13(19):1414-21. doi: 10.1038/sj.gt.3302798. Epub 2006 May 25.
Reference Type
BACKGROUND
Okada S, Inoue H, Yamauchi K, Iijima H, Ohkawara Y, Takishima T, Shirato K. Potential role of interleukin-1 in allergen-induced late asthmatic reactions in guinea pigs: suppressive effect of interleukin-1 receptor antagonist on late asthmatic reaction. J Allergy Clin Immunol. 1995 Jun;95(6):1236-45. doi: 10.1016/s0091-6749(95)70081-1.
Reference Type
BACKGROUND
Chen Y, Garvin LM, Nickola TJ, Watson AM, Colberg-Poley AM, Rose MC. IL-1beta induction of MUC5AC gene expression is mediated by CREB and NF-kappaB and repressed by dexamethasone. Am J Physiol Lung Cell Mol Physiol. 2014 Apr 15;306(8):L797-807. doi: 10.1152/ajplung.00347.2013. Epub 2014 Jan 31.
Reference Type
BACKGROUND
Evans CM, Raclawska DS, Ttofali F, Liptzin DR, Fletcher AA, Harper DN, McGing MA, McElwee MM, Williams OW, Sanchez E, Roy MG, Kindrachuk KN, Wynn TA, Eltzschig HK, Blackburn MR, Tuvim MJ, Janssen WJ, Schwartz DA, Dickey BF. The polymeric mucin Muc5ac is required for allergic airway hyperreactivity. Nat Commun. 2015 Feb 17;6:6281. doi: 10.1038/ncomms7281.
Reference Type
BACKGROUND
Garlanda C, Dinarello CA, Mantovani A. The interleukin-1 family: back to the future. Immunity. 2013 Dec 12;39(6):1003-18. doi: 10.1016/j.immuni.2013.11.010.
Reference Type
BACKGROUND
Hernandez ML, Mills K, Almond M, Todoric K, Aleman MM, Zhang H, Zhou H, Peden DB. IL-1 receptor antagonist reduces endotoxin-induced airway inflammation in healthy volunteers. J Allergy Clin Immunol. 2015 Feb;135(2):379-85. doi: 10.1016/j.jaci.2014.07.039. Epub 2014 Sep 5.
Reference Type
BACKGROUND
Other Identifiers
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17-1395
Identifier Type: -
Identifier Source: org_study_id
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Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
NCT04046939
COMPLETED
PHASE2
DNA Vaccine for Ragweed Allergic Adults
NCT00346086
COMPLETED
PHASE2
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
NCT00813748
COMPLETED
Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
NCT07038746
RECRUITING
PHASE1
Study Of Patients With Allergic Rhinitis And Asthma
NCT00296530
COMPLETED
PHASE4
Phase 2 Study in Adults Sensitized to Short Ragweed
NCT00670384
WITHDRAWN
PHASE2
A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
NCT00609674
COMPLETED
PHASE4
Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
NCT04673591
COMPLETED
PHASE2
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
NCT00127647
COMPLETED
PHASE3
Bioavailability of Nasal Epinephrine
NCT04696822
COMPLETED
PHASE1
Evaluation of a Nasal Allergen Challenge Procedure Using Dust Mite Extract
NCT00927329
WITHDRAWN
PHASE1
Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers.
NCT03023397
TERMINATED
PHASE1
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
NCT00396409
COMPLETED
PHASE3
3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
NCT01794741
COMPLETED
PHASE3
Screening Inhaled Allergen Challenge for Dermatophagoides Farinae
NCT03049111
TERMINATED
EARLY_PHASE1
Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity
NCT00513487
COMPLETED
NA
Identification of Allergic Asthmatics Reactive to Felis Catus (Cat Hair) Allergen Inhalation
NCT03780387
TERMINATED
EARLY_PHASE1
Study Of Allergic Rhinitis In Patients Who Also Have Asthma
NCT00296491
COMPLETED
PHASE4