Reference no: EM131670603 , Length: 15
You need to prepare 20 listing from 20 different SAS data set.
Provide Statistical analysis plan (mock listing) and Protocol and eCRL. Only 5- patient in the study.
Only listing is required, No analysis is required.
Diagnosis and main criteria for inclusion:
Inclusion Criteria:
1. Provided written informed consent to participate
2. Male and non-pregnant, non-lactating female subjects aged 18-50 years, inclusive
3. Confirmed diagnosis of cystic fibrosis, defined as clinical features/symptoms consistent with CF and at least 1 of the following:
a. Documented sweat chloride test? 60 mEq/L by quantitative pilocarpine iontophoresis, or;
b. Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene. The original documentation of genetic testing is not required if the specific genetic mutations are documented in the subjects' medical records.
Note: Individuals with clinical features/symptoms of CF, but with no or only 1 CF-causing mutation may not be enrolled
4. Screening Forced Expiratory Volume at I second (FEV1) > 40% of predicted normal.
5. Stable CF lung disease defined as no pulmonary exacerbation or acute upper or lower respiratory illness (exception of allergic or nonallergic rhinitis) other than CF within the past 28 days and none of the following:
a. Hemoptysis within 28 days of screening
b. Pneumothorax within 28 days of screening
c. History of positive culture for Burkholderia species or Mycobacterium abscessus within the past 2 years
6. No recent significant changes (removal or addition) to inhaled or oral CF medication within the past I month and no anticipation of need to change these medications during study participation.
7. Ongoing concomitant medications may be taken during the study provided the dose and regimen has been stable for 28 days before screening and is anticipated to remain stable throughout the study. Specific requirements for allowed ongoing concomitant medications/treatments are below. There is no requirement that subjects be on these therapies:
a. Inhaled antibiotic use: Stable antibiotic medication defined as at least two complete 28-day courses of therapy (continuous therapy with single medication or alternating medication with multiple medications)
b. Hypertonic saline: Stable use of daily hypertonic saline (>0.9% to 7%)
c. Dornase alfa: Stable use of daily or intermittent dornase al&
d. Oral CFTR correctors/modifiers: Stable dose/regimen for at least 60 days
e. Bronchodilators (oral, inhaled): SABAs and long acting J32-agonists (LABAs) are allowed. On all clinic days, SABA therapy should be completed at least 2 hours before the anticipated time of pre-dose spirometry in the clinic. LABA therapy, if required, should be taken the evening before each clinic visit (instead of the morning). LABA administration on non-clinic visit days should be per the subjects' usual regimen.
f. Inhaled corticosteroids, any dose
8. Stable chest physiotherapy routine for at least 28 days
9. All females of child-bearing potential who are sexually active must understand that pregnancy is to be avoided during their participation in the study. Sexually active females should use effective contraceptive measures, defined as oral or implantable contraceptives, intrauterine device, or double barrier method. Females who are in same sex relationships may participate without contraceptive use at the discretion of the Investigator
10. Able and willing in the judgement of the PI to attend study visits and comply with study procedures.
Exclusion Criteria:
1 . Significant unstable co-morbidities within 28 days of screening as judged by the PI, including significant renal or hepatic disease or any significant respiratory disease other than CF.
Subjects with co-morbidities associated with CF including diabetes and liver disease are permitted per the judgment of the PI. NOTE: Liver disease defined as a biliary cirrhosis with bilirubin >2 times upper limit normal (ULN) and/ or hepatic transaminases >5 times ULN and/or portal hypertension are exclusionary.
2. Has received an investigational drug within the past 30 days
3. Has received an immunization within the past 7 days, including influenza
4. Requirement for supplemental oxygen of more than 2 L/min, unless being used for comfort only; subjects must have been on a stable regimen for at least 60 days before screening
5. History of diagnosis with allergic bronchopulmonary aspergillosis (ABPA)
6. Requirement for >10 mg prednisone or equivalent during the 28 days prior to screening. Subjects taking < I0 mg prednisone or equivalent may participate provided they have been on this medication for at least 28 days prior to screening
7. Current use of tobacco or tetrahydrocannabinol (THC)-containing products, delivered orally, by vaporizing, or by smoking. Subjects with a >10 pack-year history of tobacco use are excluded.
8. Has received any organ transplant or who have undergone major surgery within the previous 6 months (requiring general anesthesia)
9. Subjects with a hypersensitivity to study drug or any excipients.
10. Subjects with history of drug and/or alcohol abuse per the judgement of the P1
11. Subjects taking antihypertensive medications or combinations containing these medications:
thiazide diuretics, spironolactone, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, spironolactone, or loop diuretics. If these medications have been used previously, they must have been discontinued at least 30 days prior to screening
12. Subjects with significant electrocardiogram (ECG) abnormalities at screening or before the first dose on Day I, including a prolonged QTcF interval (>440 msec in males and >460 msec in females)
Attachment:- Datasets.zip