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<h1>Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations</h1>

Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations

Original Article from The New England Journal of Medicine — Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations

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Karmok, Hauke, Roy and Tamkosch Wallis and futuna

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Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

<h1>Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC</h1>

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

Criteria Main Inclusion Criteria: Part A (1st line, PD-X naïve NSCLC): histologically- or cytologically-confirmed diagnosis of non-small cell lung carcinoma stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable) Part B (2nd line, PD-X refractory NSCLC): histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with at least 2 cycles of any PD-1/PD-L1 containing based therapy (i.e. nivolumab, pembrolizumab, avelumab, durvulumab, etc) alone, or in combination with any other immunotherapeutic or chemotherapy. Note: failure = progress acc to RECIST 1.1: on therapy or within 12 weeks after end of PD 1/PD-L1 containing therapy Part C (2nd line PD-X naive HNSCC): Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies after failure of prior platinum-based therapy. Submission of formalin-fixed diagnostic tumor tissue ECOG performance status 0-1. Main Exclusion Criteria: For part A (1st line, PD-X naïve NSCLC): The NSCLC can be treated with curative intent with either surgical resection and/or chemoradiation and/or radiation. Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. EGFR-sensitizing mutation and/or is EML4 gene/ ALK gene fusion positive (ALK translocation). For Part B (2nd line, PD-X refractory NSCLC): Symptomatic ascites or pleural effusion. > 1 line of chemotherapy for metastatic disease. For Part C (2nd line PD-X naive HNSCC): Disease is suitable for local therapy administered with curative intent. Previously treated with > 1 systemic regimens for recurrent and/or metastatic disease. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) (Part A and C only) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE (Part B only) Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery, another systemic cancer therapy or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to cycle 1 day 1. Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia and elevated transaminases in case of liver metastases may be eligible. If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Known active central nervous system metastasis and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable: i.e. without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement for steroid treatment for at least 14 days prior to cycle 1 day 1. Receives continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease. Contacts and Locations Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625323 Contacts

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Relapsing Polychondritis

<h1>Relapsing Polychondritis</h1>

Relapsing Polychondritis

Relapsing polychondritis is an uncommon, chronic disorder of the cartilage. Relapsing polychondritis is characterized by recurrent episodes of painful inflammation. Relapsing polychondritis can involve all types of cartilage. Typical cartilage tissues affected include the ears, nose, and joints. There is no one specific test for diagnosing relapsing polychondritis. Treatment often involves cortisone-related medications. The course of symptoms for patients is often unpredictable. What is relapsing polychondritis?
Relapsing polychondritis is an uncommon, chronic disorder of the cartilage that is characterized by recurrent episodes of inflammation of the cartilage of various tissues of the body. Chondritis means inflammation of cartilage. Tissues containing cartilage that can become inflamed include the ears, nose, joints, spine, and windpipe (trachea). The eyes, heart, and blood vessels, which have a biochemical makeup similar to that of cartilage, can also be affected. Relapsing polychondritis is sometimes called the red ear syndrome. What causes relapsing polychondritis?
The cause of relapsing polychondritis is unknown. It is suspected that this condition is caused by “autoimmunity.” Autoimmunity is characterized by a misdirected immune system. This results in inflammation in various tissues of the body. What are signs and symptoms of relapsing polychondritis? Share Your Story
Typically, relapsing polychondritis causes sudden pain in the inflamed tissue at the onset of the disease. Common symptoms are pain , redness, swelling, and tenderness in one or both ears, the nose, throat, joints, and/or eyes. The lobe of the ear is not involved. Fever , fatigue , and weight loss often develop.
Inflammation of the ears and nose can cause deformity (saddle nose deformity and floppy ears) from weakened cartilage. Impaired hearing , balance, and nausea can be caused by inner ear inflammation .
Inflammation of the windpipe or trachea can lead to throat pain, hoarseness , and breathing difficulty. This is a potentially dangerous area of inflammation in patients with relapsing polychondritis and can require assisted breathing methods when severe.
Joint inflammation ( arthritis ) can cause pain, swelling, and stiffness of the joints, including of the hands, knees, ankles, wrists, and feet .
Eye inflammation can be mild or severe and can damage vision. Cataracts can be caused by the inflammation or from the cortisone used to treat relapsing polychondritis (see below).
Other tissues that can develop inflammation include the aorta (which can lead to aneurysm or aortic valve weakness ), tissues in or around the heart ( myocarditis and pericarditis ), the skin ( vasculitis ), and the nerves from the brain (cranial nerve palsies). Relapsing Polychondritis Symptom Arthritis
Arthritis is a joint disorder featuring inflammation. A joint is an area of the body where two different bones meet. A joint functions to move the body parts connected by its bones. Arthritis literally means inflammation of one or more joints. Learn more about arthritis » How do doctors diagnose relapsing polychondritis?
Relapsing polychondritis is diagnosed when the doctor recognizes the classic pattern of cartilage involvement during the history and physical examination. The symptoms described above can suggest the disease.
There is no one specific test for diagnosing relapsing polychondritis. Blood tests that indicate inflammation, such as an elevated erythrocyte sedimentation rate (ESR), C-reactive protein , and others, are often abnormal when the disease is active.
If tissue cartilage is biopsied, the involved cartilage will demonstrate nonspecific signs of inflammation. Can relapsing polychondritis be associated with other diseases?
Yes. The doctor will be interested in determining whether or not signs of the following diseases are present along with relapsing polychondritis: vasculitis, granulomatosis with polyangiitis , systemic lupus erythematosus , ankylosing spondylitis , Reiter’s disease, psoriatic arthritis , rheumatoid arthritis , Behcet’s disease , Churg-Strauss syndrome , polyarteritis nodosa , myelodysplasia, and others. What medications are used to treat relapsing polychondritis? Share Your Story
For patients with more mild disease, nonsteroidal anti-inflammatory drugs ( NSAIDs ), including ibuprofen ( Motrin ), naproxen ( Naprosyn ), and others, can be helpful to control the inflammation. Usually, however, cortisone-related medications (steroids such as prednisone and prednisolone ) are required. High-dose steroids are frequently necessary initially, especially when the eyes or breathing airways are involved. Moreover, most patients require steroids for long-term use.
Methotrexate ( Rheumatrex , Trexall ) has shown promise as a treatment for relapsing polychondritis in combination with steroids as well as a maintenance treatment. Studies have demonstrated that methotrexate can help reduce the steroid requirements.
Other medications that have been tried in small numbers of patients with some reports of success include cyclophosphamide ( Cytoxan ), dapsone , azathioprine (Imuran), penicillamine ( Depen , Cuprimine ), cyclosporine , anti- tumor necrosis factor (TNF) biologic medications ( adalimumab [ Humira ], infliximab [ Remicade ]), and combinations of these drugs with steroids.

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