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Observational Completed with Results
STOP: Standardized Treatment of Pulmonary Exacerbations Pilot Study (FLUME13A1)
This study evaluated current physician treatment practices and patient outcomes for the management of pulmonary exacerbations (PEx). The goal was to collect this information so that it could later inform a future study of treatments of PEx, called the STOP 2 study. Researchers followed individuals with CF who were initially admitted to the hospital for treatment of a pulmonary exacerbation with intravenous (IV) antibiotics and then researchers evaluated them at 28 days after the start of treatment. Antibiotic selection, dose, and treatment duration were determined by the treating physician and were not dictated by the study. On the first day of the study, physicians were asked to capture whether their goal was to recover the participant’s lung function or to improve symptoms. The physician also recorded a target lung function number (measured by FEV1) so that at the end of treatment they could determine if the treatment was a ‘success’ or a ‘non-success’. At the end of the study, physicians reported whether or not they considered the treatment a success. Spirometry, patient and clinician reported outcomes, treatments, and duration of hospitalization were collected and entered into the CFF National Patient Registry (CFFNPR) during hospitalization and after discharge.
Eligibility
See other primary eligibility criteria for more information.
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Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
1. Previous enrollment in this study 2. Treatment with IV antibiotics in the previous 6 weeks 3. Admission to the intensive care unit for current pulmonary exacerbation 4. Pneumothorax on admission 5. Hospitalization for scheduled pulmonary clean out 6. Hospitalization for sinusitis 7. Massive hemoptysis defined as > 250 cc in a 24 hour period, or 100 cc/day over 4 consecutive days 8. Pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA) 9. Ongoing treatment with prednisone equivalent >10 mg/day for greater than 2 weeks initiated prior to Visit 1 10. History of solid organ transplantation 11. Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g. M. abscessus, M. avium complex)
Study Results
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What We Learned:
This study evaluated physician treatment practices and patient outcomes for the management of pulmonary exacerbations (PEx). The study showed that there is a wide variety of treatment practices for PEx. The outcomes of this study were used to design the STOP 2 interventional study.
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Primary Findings:
Effectiveness:
This study was conducted between January 2014 and January 2015. The study enrolled 220 participants. All participants were treated with IV antibiotics. Researchers separated their observations into three categories: 1) treatment practices, 2) treatment outcomes, and 3) end of treatment assessment. Treatment Practices: Key observations about IV antibiotic treatment practices included: the average amount of time of antibiotic treatment was 15.9 days, individuals with more severe lung disease (<50% FEV1) were treated nearly two days longer than individuals with higher lung function (>50% FEV1), and there was no difference in duration of IV antibiotics in individuals with Pseudomonas aeruginosa (PA) or methicillin-resistant Staphylococcus aureus (MRSA). Additionally, the type of antibiotic given varied: 10% of participants were also prescribed inhaled antibiotics and 32% were prescribed one or more oral antibiotics in addition to their IV antibiotic treatment (more common in the pediatric population at 45% than in adults at 29% s, p=0.065).
Treatment Outcomes: Response to treatment was also evaluated. The average increase in lung function from initial hospitalization to the end of IV antibiotic treatment was 9% (measured by absolute FEV1). Also, there was greater lung function improvement in those participants for whom the physician treatment goal was to recover lung function than for those whose goal was symptom relief (FEV1 increase of 10% for lung function recovery versus 4% for symptom relief, p<0.001). However, the participants whose treatment goal was to recover lung function also had a greater drop in lung function at the time of hospitalization than those who had symptom relief as their treatment goal (12% vs. 7%, p=0.004). Those participants whose best lung function in the 6 months prior was >50% FEV1 had a greater recovery of lung function at day 28 than those whose best lung function in the 6 months prior was <50%.Patient reported symptoms improved from the start of IV antibiotic treatment to the end of treatment as measured by the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic Respiratory Infection Symptom Score (CRISS) (47.5 to 21.5, p<.001), with 88% of participants achieving the clinically significant 11-point CRISS improvement. End of Treatment Assessments: Physicians had different primary reasons for stopping IV therapy, with end of planned treatment duration being the most common reason (31%). The participants whose treatment was considered a ‘success’ by their physician had a greater improvement in day 28 lung function than those whose treatment was considered a ‘non-success’ (p=0.002).
Safety:
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Citation:
J Cyst Fibros 2017;DOI 10.1016/j.jcf.2017.04.003;16(5):600-606
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Observational -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
28 days -
Number of Study Visits:
4
Additional Information
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Flume, Patrick -
Study Drugs:
N/A
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
Other Primary Eligibility Criteria
1. Previous enrollment in this study 2. Treatment with IV antibiotics in the previous 6 weeks 3. Admission to the intensive care unit for current pulmonary exacerbation 4. Pneumothorax on admission 5. Hospitalization for scheduled pulmonary clean out 6. Hospitalization for sinusitis 7. Massive hemoptysis defined as > 250 cc in a 24 hour period, or 100 cc/day over 4 consecutive days 8. Pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA) 9. Ongoing treatment with prednisone equivalent >10 mg/day for greater than 2 weeks initiated prior to Visit 1 10. History of solid organ transplantation 11. Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g. M. abscessus, M. avium complex)
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