Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhaled in Patients With Cystic fibrosis dating Fibrosis. To evaluate the change in forced expiratory volume FEV1 from baseline to Day between Cipro Inhale-treated and placebo-treated subjects cystic fibrosis dating a 4-week treatment period. E-mail: [email protected]. Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis. Freigeben Facebook Twitter LinkedIn. Zurück zu den Suchergebnissen Trial Condition s : Zystische Fibrose Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhaled in Patients With Cystic Fibrosis. Bayer Identifier: EudraCT Number: View results Ask a Question. Wichtige Teilnahmebedingungen Geschlecht. Alter 12 Jahre Keine Begrenzung. Einschlusskriterien - Subjects, or their. Zusammenfassung der Studie Enrollment Goal Trial Dates May January Phase 2. Könnte ich ein Scheinmedikament erhalten? Products Ciprofloxacin DPI BAYQ Accepts Healthy Volunteers Nein. Wo Sie teilnehmen können Ladevorgang Ask a Question. Studienstandorte Studienstandorte. Studiendesign Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Trial Type : Interventional. Intervention Type : Drug. Trial Purpose : Treatment. Allocation : Randomized. Blinding : Double Blind. Assignment : Parallel Assignment. Trial Arms : 4. Secondary Outcome Change from baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9. Timeframe : Baseline and Visit 4 DayVisit 5 DayVisit 8 Dayand Visit 9 Day 56 Change from baseline in P. Timeframe : Baseline and Visit 4 DayVisit 5 DayVisit 7 DayVisit 8 Dayand Visit 9 Day 56 Change from baseline in forced vital capacity FVC at visits 4, 5, 7, 8 and 9. Number of participants developing ciprofloxacin-resistant mucoid P. Number of participants developing ciprofloxacin-resistant non-mucoid P. Effect of ciprofloxacin DPI treatment on quality of life measured by Cystic Fibrosis Quality of Life Questionnaire Revised CFQ-RRespiratory scale. Timeframe : Baseline and Visit 7 Day and Visit 9 Day 56 Plasma concentrations of ciprofloxacin from selected participants during treatment. Sputum concentrations of ciprofloxacin from selected participants during treatment. Number of participants with occurrence of drug induced Bronchospasms. Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. Click here to find results for studies related to Bayer Healthcare products. Folgen Sie uns.
Zystische Fibrose
Drug therapies for reducing gastric acidity in people with cystic fibrosis - PMC Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis date) - Ability to perform reproducible pulmonary. Unlocking the Secrets of Cystic Fibrosis: A Genetic Study of people with CF in Germany Date. Friday, October 20, Featured resource article. Thieme E-Journals - Seminars in Respiratory and Critical Care Medicine / AbstractStudienstandorte Nemour's Children's Clinic - Orlando Orlando, United States, Studienstandorte Monmouth Medical Center Long Branch, United States, Smith Phase 2. There were no withdrawals.
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Added value of this study. Up to 24 weeks of treatment with elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was efficacious and safe in patients with cystic fibrosis ≥12 years of age who. Current CFTR modulator therapies, such as elexacaftor–tezacaftor–ivacaftor, have transformed cystic fibrosis care. Friday, October 20, Featured resource article. Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis date) - Ability to perform reproducible pulmonary. Unlocking the Secrets of Cystic Fibrosis: A Genetic Study of people with CF in Germany Date.For future updates of the review we will test for heterogeneity using the Chi 2 test and I 2 statistic. We have invited international experts to write these up-to-date reviews based on their research or clinical expertise and extensive experience within this field. We would urge trialists to recognise that the results of individual randomised controlled trials are likely to be included in systematic reviews such as this. A search of the Group's Cystic Fibrosis Trials Register did not identify any references potentially eligible for inclusion in this review. Dezember online. Interventions 2 groups: 1. A search of the Cystic Fibrosis and Genetic Disorders Group's Trials Register identified a single new reference which has been included in the review DiMango Dudley Santamaria Outcomes Faecal fat, weight, nitrogen, bile acids, anthropometric measurements, bone age, peak flow, Crispin Norman score, Shwachman score, haemoglobin, albumin, calcium, creatinine and plasma vitamin A levels. No new references have been added to the review at this update. Maish We considered the risk of bias from blinding to decrease if more people were blinded to the intervention and the risk of bias to be unclear if this aspect of trial quality was not discussed. The included trial reported diarrhoea and abdominal discomfort as adverse effects in participants on the prostaglandin E2 analogue, enprostil treatment Heijerman No new data were added at this update, so our conclusions remain the same. This trial measures gastric inhibitory polypeptide and insulin response in CF. For 12 of the 96 admissions Pathophysiology: The cystic fibrosis transmembrane conductance regulator CFTR gene defect leads to increased viscosity of sinonasal secretions and reduced mucociliary clearance, causing chronic infection and inflammation in the upper airway segment and, consequently, to CF-CRS. DiMango reported that participants receiving esomeprazole experienced a shorter time to first exacerbation compared with placebo, but the difference was not statistically significant. Studienstandorte Akademiska barnsjukhuset Uppsala, Sweden, The different drugs studied caused some adverse events; mainly diarrhoea two people withdrew from one trial because of this and bloating due to wind. Gow This trial contained 4 treatment periods, 3 of which used interventions that were not relevant to the review, therefore no comparisons could be made. Outcomes Clinical state, weight, height, skinfold thickness, lung function tests, PABA peptide test, plasma lipid and lipoprotein. Durie reported that two participants complained of gaseous abdominal distension while taking sodium bicarbonate and one participant was forced to withdraw from the trial because of possible neurological complications due to cimetidine Durie Sputum concentrations of ciprofloxacin from selected participants during treatment. When trials did not report data in such a way that a correct analysis could be performed, the results were described narratively within the text rather than combine the results using inappropriate techniques. Clinical state, weight, height, skinfold thickness, lung function tests, PABA peptide test, plasma lipid and lipoprotein. Risk of bias Bias Authors' judgement Support for judgement Random sequence generation selection bias Unclear risk States participants randomly allocated, but no details given. Studies have suggested that drug therapy which reduces gastric acid may improve the effectiveness of pancreatic replacement therapy DiMagno In 10 trials there were a low number of participant withdrawals and these were described, but in the remaining trial there was a discrepancy between the number of participants entering and completing the trial which was not addressed Bowler We will consider the ranges of I 2 to relate to the degree of heterogeneity as follows:.
