Please select the eligibility criteria that correspond to the clinical trial below.
Title: Early Intervention in Cystic Fibrosis Exacerbation
Brief Summary: Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.


Options:
A: Key Inclusion Criteria:

* Heterozygous for the F508del mutation (F/MF)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
B: Inclusion Criteria:

* CF diagnosis confirmed with sweat test, abnormal nasal potential difference and/or genetic testing
* Age 14 and older
* Able to perform spirometry
* Clinically stable without antibiotic treatment for a pulmonary exacerbation in the two weeks prior to the screening visit
* Forced expiratory volume in the first second (FEV1) greater than 25% of predicted at screening

Exclusion Criteria:

* History of solid organ transplant
* Participation in any interventional trial within the last 30 days
* Inability to speak and read the English language well enough to complete questionnaires
* Colonization with Burkholderia cepacia genomovar III within the last 24 months
* Currently receiving antimicrobial treatment specifically used to treat active non-tuberculosis mycobacterium
* Confirmed diagnosis of allergic bronchopulmonary aspergillosis (ABPA) as defined by the Cystic Fibrosis Foundation (CFF) guidance document that is being actively treated
C: Inclusion Criteria:

* Confirmed diagnosis of Cystic Fibrosis
* Age ≥12 years
* Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
* Access to the internet

Exclusion Criteria:

* Participation in another clinical trial up to 4 weeks prior to the first baseline visit
* Pregnancy/Breastfeeding
* Inability to exercise
* More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months.
* Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
* Cardiac arrhythmias with exercise
* Requiring additional oxygen with exercise
* Recent diagnosis of diabetes 3 months prior to screening or at screening
* Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline)
* At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial
* Colonization with Burkholderia cenocepacia
D: Inclusion Criteria:

* Clinically stable CF patients
* Age \> 18 years
* Confirmed diagnosis of CF
* Access to a smartphone/tablet to access and upload to Fitbit Application.
* Capacity and willingness to give explicit informed consent

Exclusion Criteria:

* FEV1 \< 25%.
* Patients on the waiting list for lung transplantation and those who have undergone lung transplantation.
* Patients with an exacerbation in the four weeks prior to the study. For the purpose of this study pulmonary exacerbation will be defined as acute or subacute worsening of respiratory symptoms which warrant change in treatment (i.e., new oral or intravenous antibiotics). Patients can undergo testing once they are finished their antibiotics and deemed clinically stable.
* Patients dependent on supplemental oxygen for exercise.
* Pregnancy
* Participation in another clinical trial up to 4 weeks prior to the first baseline visit

Answer: B