Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. intensive care patients 2. inability to use a nebulizer with a mouthpiece. 3. history of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. 4. untreated oral candidiasis. 5. evidence of symptomatic chronic or acute respiratory infection other than covid-19 in the previous 8 weeks. 6. proven diagnosis of chronic obstructive pulmonary disease, asthma or bronchiectasis. 7. pulmonary malformations, tuberculosis, cystic fibrosis. 8. history or presence of severe renal (stage 4 (gfr = 15-29 ml/min)) and/or severe hepatic impairment(s) (grade 4 or above) 9. anticipated transfer to another hospital within 72 hours. 10. use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before screening visit. 11. systemic corticosteroids (e.g., dexamethasone) within 28 days before screening visit. 12. female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. 13. any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. 14. current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

1. intensive care patients 2. inability to use a nebulizer with a mouthpiece. 3. history of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. 4. untreated oral candidiasis. 5. evidence of symptomatic chronic or acute respiratory infection other than covid-19 in the previous 8 weeks. 6. proven diagnosis of chronic obstructive pulmonary disease, asthma or bronchiectasis. 7. pulmonary malformations, tuberculosis, cystic fibrosis. 8. history or presence of severe renal (stage 4 (gfr = 15-29 ml/min)) and/or severe hepatic impairment(s) (grade 4 or above) 9. anticipated transfer to another hospital within 72 hours. 10. use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before screening visit. 11. systemic corticosteroids (e.g., dexamethasone) within 28 days before screening visit. 12. female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. 13. any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. 14. current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

Nov. 16, 2021, 6:30 p.m. usa

intensive care patients inability to use a nebulizer with a mouthpiece. history of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. untreated oral candidiasis. evidence of symptomatic chronic or acute respiratory infection other than covid-19 in the previous 8 weeks. proven diagnosis of chronic obstructive pulmonary disease, asthma or bronchiectasis. pulmonary malformations, tuberculosis, cystic fibrosis. history or presence of severe renal (stage 4 (gfr = 15-29 ml/min)) and/or severe hepatic impairment(s) (grade 4 or above) anticipated transfer to another hospital within 72 hours. use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before screening visit. systemic corticosteroids (e.g., dexamethasone) within 28 days before screening visit. female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

intensive care patients inability to use a nebulizer with a mouthpiece. history of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. untreated oral candidiasis. evidence of symptomatic chronic or acute respiratory infection other than covid-19 in the previous 8 weeks. proven diagnosis of chronic obstructive pulmonary disease, asthma or bronchiectasis. pulmonary malformations, tuberculosis, cystic fibrosis. history or presence of severe renal (stage 4 (gfr = 15-29 ml/min)) and/or severe hepatic impairment(s) (grade 4 or above) anticipated transfer to another hospital within 72 hours. use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before screening visit. systemic corticosteroids (e.g., dexamethasone) within 28 days before screening visit. female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

Aug. 12, 2021, 4 p.m. usa

1. intensive care patients 2. inability to use a nebulizer with a mouthpiece. 3. history of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. 4. untreated oral candidiasis. 5. evidence of symptomatic chronic or acute respiratory infection other than covid-19 in the previous 8 weeks. 6. proven diagnosis of chronic obstructive pulmonary disease, asthma or bronchiectasis. 7. pulmonary malformations, tuberculosis, cystic fibrosis. 8. history or presence of severe renal (stage 4 (gfr = 15-29 ml/min)) and/or severe hepatic impairment(s) (grade 4 or above) 9. anticipated transfer to another hospital within 72 hours. 10. use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before screening visit. 11. systemic corticosteroids (e.g., dexamethasone) within 28 days before screening visit. 12. female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. 13. any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. 14. current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study

1. intensive care patients 2. inability to use a nebulizer with a mouthpiece. 3. history of hypersensitivity to corticosteroid or to any of the excipients in the drug preparation. 4. untreated oral candidiasis. 5. evidence of symptomatic chronic or acute respiratory infection other than covid-19 in the previous 8 weeks. 6. proven diagnosis of chronic obstructive pulmonary disease, asthma or bronchiectasis. 7. pulmonary malformations, tuberculosis, cystic fibrosis. 8. history or presence of severe renal (stage 4 (gfr = 15-29 ml/min)) and/or severe hepatic impairment(s) (grade 4 or above) 9. anticipated transfer to another hospital within 72 hours. 10. use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of beclomethasone per day, within 7 days before screening visit. 11. systemic corticosteroids (e.g., dexamethasone) within 28 days before screening visit. 12. female patients who are breast-feeding, lactating, pregnant or intending to become pregnant. 13. any condition, including findings in the patients' medical history or in the pre-randomization study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. 14. current or previous participation in another clinical trial where the patient has received a dose of an study drug containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study