Biologic Specimen and Data Repository Information Coordinating Center

The Karma trial investigated the efficacy and safety of Ketoconazole and Respiratory Management in the treatment of ALI and ARDS. The ARMA component compared two ventilator strategies: a tidal volume of 6 mL/kg versus 12 mL/kg. The LARMA phase of the study investigated the efficacy of Lisofylline and Respiratory Management.

ARDSNet-ALTA tested the hypothesis that an aerosolized beta-2-agonist, albuterol, would improve clinical outcomes in patients with ALI and ARDS.

ARDSNet-Omega investigated if dietary supplementation of omega-3 (n-3) fatty acids, ?-linolenic acid and antioxidants to patients with ALI would increase ventilator-free days to study day 28.

ARDSNet-EDEN tested if initial lower-volume trophic enteral feeding would increase ventilator-free days and decrease gastrointestinal intolerances compared with initial full enteral feeding in ALI patients.

ARDSNet-SAILS assessed the efficacy and safety of oral rosuvastatin in patients with sepsis-induced ALI and test the hypothesis that rosuvastatin therapy would improve the clinical outcomes of critically ill patients with sepsis-associated ARDS.

ARDSNet-LASRS tested the effects of methylprednisolone, a corticosteroid, compared to placebo, on mortality at 60 days in patients with persistent ARDS.

ARDSNet-ALVEOLI compared clinical outcomes of patients with ALI and ARDS treated with a higher end-expiratory lung volume/lower FiO2 versus a lower end-expiratory lung volume/higher FiO2 ventilation strategy.

ARDSNet-FACTT evaluated the benefits and risks of Pulmonary Artery Catheters (PACs) in patients with established ALI by comparing hemodynamic management guided by a PAC with hemodynamic management guided by a central venous catheter.

ACRN-BARGE examined the use of regularly scheduled albuterol treatment in asthma, in a genotype-stratified, randomized, placebo-controlled cross-over trial in patients with mild asthma.

ACRN-BAGS tested the hypothesis that in patients with mild asthma, whose only asthma treatment is inhaled Beta-agonists, addition of regular inhaled Beta-agonist treatment to treatment on an "as needed only" basis will result in no effect on asthma control.

ACRN-CIMA tested the therapeutic benefit of colchicine as measured by maintenance of control when inhaled steroids are discontinued in patients with moderate asthma.

ACRN-DICE aimed to establish a reliable method to evaluate systemic bioavailability and to determine equisystemic effects in inhaled corticosteroids.

ACRN-IMPACT evaluated the efficacy of intermittent short-course corticosteroid treatment guided by a symptom-based action plan alone or in addition to daily treatment with either inhaled budesonide or oral zafirlukast over a one-year period.

ACRN-MICE compared the relative beneficial and systemic effects in a dose-response relationship for two inhaled corticosteroids: beclomethasone dipropionate and fluticasone propiante.

ACRN-PRICE evaluated potential biomarkers of predicting short-term response to inhaled corticosteroid with subsequent evaluation of responders and non-responders to asthma control over a longer interval.

ACRN-SOCS and ACRN-SLIC were concurrently managed clinical trials that investigated whether inhaled corticosteroid therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting beta 2-agonist to their treatment regimen.

ACRN-SLiMSIT evaluated the clinical efficacy of regular asthma treatment with the combination of a leukotriene receptor antagonist (montelukast) and a long-acting beta-agonist (salmeterol).

ACRN-SMOG evaluated if the response to an inhaled corticosteroid or a leukotriene receptor antagonist is attenuated in individuals with asthma who smoke.

ACRN-BASALT investigated if adjustment of inhaled corticosteroid therapy based on exhaled nitric oxide or day-to-day symptoms is superior to guideline-informed, physician assessment-based adjustment in preventing treatment failure in adults with mild to moderate asthma. ACRN-TALC examined the effectiveness of the medication tiotropium bromide combined with a low dose of inhaled corticosteroid at maintaining asthma control in people with moderately severe asthma.

ACRN-LARGE evaluated whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids would have a detrimental effect on asthma control in people who bear the B16 Arg/Arg genotype of the beta-2 adrenergic receptor gene.

ACRN-MIA tested the hypothesis that clarithromycin would improve asthma control in individuals with mild-to-moderate persistent asthma that was not well-controlled despite treatment with low-dose inhaled corticosteroids.

The MICROBIOME study aimed to compare the bronchial bacterial microbiota in adults with steroid-naive atopic asthma, with atopy but no asthma, and non-atopic healthy subjects; and to determine whether inhaled corticosteroid treatment alters bronchial microbial community composition in adults with asthma.

The APRIL study evaluated the early administration of azithromycin in preschool children with recurrent severe lower respiratory tract illnesses and found that it reduced the likelihood of severe illness. The OCELOT study assessed the efficacy of oral corticosteroids in decreasing the severity of symptoms of children whose episode progressed to recurrent severe wheezing, but the trial was prematurely terminated due to a lack of feasibility.

The BARD trials evaluated whether patients of African American heritage with inadequately controlled asthma benefit from the addition of a long-acting beta-agonist and/or increased glucocorticoids dosage in order to determine a preferred pharmacotherapy strategy in African American children, adolescents, and adults.

INFANT was designed to determine whether individual young children with mild persistent asthma responded better to one treatment than another and, if so, whether those children can be identified by phenotypic characteristics. AVICA compared the use of acetaminophen to the use of ibuprofen on asthma exacerbations among young children with mild persistent asthma.

ALFA aimed to determine whether alendronate can reduce long-acting beta-2-adrenergic receptor agonist-associated loss of bronchoprotection in inhaled corticosteroid-treated patients.

AsthmaNet-STICS was a double-blind, parallel-group trial that assessed the efficacy and safety of increasing the dose of inhaled glucocorticoids by a factor of 5 for 7 days in school-age children with mild-to-moderate persistent asthma at the early signs of loss of asthma control.

SIENA was designed to compare an inhaled glucocorticoid with placebo and a long-acting muscarinic antagonist with placebo in patients with mild, persistent asthma, according to the patient's sputum eosinophil level at baseline.

VIDA was designed to evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.

CARE-CLIC evaluated if response to inhaled corticosteroids and leukotriene receptor antagonists is similar in children with mild-to-moderate persistent asthma, or if children who do not respond to one medication respond to the other.

The CARE-AIMS study compared the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist on reduction of morbidity in preschoolers with moderate-to-severe intermittent wheezing.

The CARE-BADGER study compared the effectiveness of a higher dose of inhaled corticosteroids (ICS), ICS combined with a long-acting beta-agonist medication, and ICS combined with a leukotriene receptor antagonist medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.

The CARE-MARS study aimed to determine if azithromycin or montelukast use would allow reduction of inhaled corticosteroids in children with moderate to severe persistent asthma.

The CARE-PACT study was designed to determine whether, in children with mild to moderate persistent asthma, similar or greater asthma control could be obtained with a regimen of a LABA and half the dose of an ICS known to be effective compared to an ICS alone or a LTRA.

The CARE-PEAK study investigated whether inhaled corticosteroids modified the subsequent development of asthma in preschool children at high risk for asthma.

CARE TREXA assessed the effectiveness of inhaled corticosteroid (ICS) combinations for long term asthma control and exacerbations in pediatric patients.

The CARE-MIST study aimed to determine whether a daily low-dose regimen of budesonide would be superior to an intermittent high-dose regimen in preschool aged children who had positive values on the modified asthma predictive index along with recurrent wheezing.

IPFNet-ACE IPF hypothesized that treatment with warfarin at recognized therapeutic doses would reduce rates of mortality, hospitalization, and declines in Forced Vital Capacity in subjects with IPF.

IPFNet-PANTHER IPF evaluated the effectiveness of a drug combination of prednisone, azathioprine, and N-acetylcysteine in the treatment of mild-to-moderate IPF compared to N-acetylcysteine alone or placebo.

IPFNet-STEP IPF evaluated if treatment with sildenafil would improve walk distance, dyspnea, and quality of life in patients with advanced IPF.

The PETAL-ASTER study assessed the utility of plasma cell-free hemoglobin level as a biomarker for future sepsis trials and whether acetaminophen would increase the number of days alive and free of organ support for patients with sepsis and respiratory or circulatory organ dysfunction.

The PETAL-CLOVERS study compared the effects of a restrictive fluid strategy (with early use of vasopressors) to a liberal fluid strategy in patients with sepsis-induced hypotension.

PETAL-LOTUS FRUIT conducted a prospective, observational study of patients with acute respiratory failure to assess the feasibility for a cluster-randomized trial of low-tidal volume ventilation versus usual care in patients with acute respiratory failure.

The PETAL-ORCHID trial evaluated whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19, with findings that did not support the use of this treatment.

The objective of PETAL-RED CORAL was to collect data for investigation of demographics, clinical characteristics, risk factors, care practices, outcomes and resource utilization of adult patients hospitalized with severe acute COVID-19.

The BLUE CORAL study measured the incidence and changes over time in symptoms, disability, and financial status after COVID-19–related hospitalization to address the knowledge gaps and provide critical data to help guide clinical care, public health, and scientific efforts.

The FIRE CORAL study examined the recovery from COVID-19 disease following acute hospitalization with an emphasis on functional, imaging, and respiratory evaluation, and assessed the feasibility of conducting a larger study to evaluate variables associated with differential recovery.

The goal of PETAL-ROSE was to determine the efficacy and safety of early neuromuscular blockade with concomitant heavy sedation as compared with a strategy of usual care with lighter sedation targets in patients with moderate-to-severe ARDS.

The PETAL-VIOLET study was initiated to evaluate the effect of short-term vitamin D supplementation on mortality among critically ill patients with a vitamin D deficiency.