Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant...
Constrictive BronchiolitisBronchiolitis Obliterans5 moreBackground: - Bronchiolitis obliterans or bronchiolitis obliterans syndrome is a lung disorder that occurs as a complication of either lung transplantation or bone marrow/blood stem cell transplantation. One of the complications of transplant is the occurrence of graft versus host disease (in hematopoietic stem cell transplants) and host versus graft disease (in lung transplantation). In these diseases, the cells attack the lungs and cause irreversible small airway fibrosis referred to as bronchiolitis obliterans syndrome. When a patient develops fibrosis of the lungs or bronchioles, the lungs no longer work properly, which causes difficulties with breathing that lead to a diminished quality of life and an increased risk of death. Treatment typically involves immunosuppressive therapy such as oral cyclosporine or steroid therapy, but these treatments are only marginally effective and can cause significant toxicities and increase the risk of infections. Inhaled cyclosporine (CIS) achieves higher concentrations of cyclosporine in the lungs and lower concentrations of cyclosporine in the blood than oral cyclosporine. Therefore, it could have advantages over conventional oral immunosuppressive therapies used to treat this disorder. Researchers are interested in testing whether inhaled cyclosporine therapy could be used as a safe and effective treatment for bronchiolitis obliterans or bronchiolitis obliterans syndrome occurring after bone marrow/blood stem cell or lung transplants. Objectives: - To evaluate whether inhaled cyclosporine (CIS) can improve or stabilize lung function and quality of life in individuals with bronchiolitis obliterans. Eligibility: - Individuals between 10 and 80 years of age who have been diagnosed with bronchiolitis obliterans or bronchiolitis obliterans syndrome after blood or lung transplants. Design: Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, lung function tests, imaging studies, bronchoalveolar lavage samples, and quality of life questionnaires. Participants will take cyclosporine inhalation solution through a nebulizer. The nebulizer generates a mist of cyclosporine inhalation solution (CIS), which is then breathed in through a mouthpiece. The process takes approximately 20 minutes. The solution will be provided in single-use vials. Participants will continue to take all medications for post-transplant care as required by their doctor and the study researchers. Attempts will be made to reduce the doses and types of immunosuppressants given to participants on the study, as long as the treatment continues to produce improved or stable lung function. Participants will have study visits every 3 weeks with blood and urine tests, lung function tests, and imaging studies. Participants will undergo repeat bronchoalveolar sample at week 9 and 18. Participants will also complete quality of life questionnaires as directed. Treatment will continue for a minimum of 18 weeks, followed by a final follow-up visit 2 weeks after the end of the study. Participants who benefit from the inhaled cyclosporine (CIS) may continue to receive further therapy with inhaled cyclosporine at the end of the study by participation in a separate study extension.
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis...
RSV BronchiolitisThis trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis. HYPOTHESES In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in: Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.
Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
Bronchiolitis ObliteransThe purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
Intravenous Magnesium in Wheezy Bronchitis
Wheezy BronchitisIn infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory. The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children. The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay. The sample size is 64 children at the age of 6 months to 4 years. If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.
Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation
Bronchiolitis ObliteransAllogeneic Stem Cell TransplantationThe purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.
A Trial of Point of Care Information in Ambulatory Pediatrics
Acute Otitis MediaAllergic Rhinitis6 moreDoes presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?
Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children
BronchiolitisViralThe purpose of this study was to determine whether a single intramuscular injection of dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
Respiratory Distress SyndromeAdult2 moreThe purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.
Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis
BronchiolitisThe primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy. This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required. Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary. All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization. Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours.
Using HFNC in Bronchiolitis
Respiratory FailureBronchiolitisThe investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).