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: Inclusion Criteria:

* ages 14 - 22 years
* have cystic fibrosis, type 1 diabetes, or inflammatory bowel disease for at least 6 months
* have access to the internet
* speak English
* has a parent that speaks English or Spanish (if primary participant is under 18)
* willingness to attend assessment visits

Exclusion Criteria:

* pregnant or have children
* have a history of substance abuse or other psychiatric disorder that would impair compliance with study protocol
B: Inclusion Criteria:

* confirmed diagnosis of CF
* age over 18 years
* the requirement for 1 or more admission to hospital to receive intravenous antibiotics over the preceding 24 months
* clinically stable at the time of recruitment
* Patients who give informed consent.

Exclusion Criteria:

* patients who are currently participating in another clinical trial (excluding observational studies)
* pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks (since these factors prevent measurement of spirometry)
* Sputum infection with Burkholderia cenocepacia or Mycobacterium abscessus
* Current diagnosis of active allergic bronchopulmonary aspergillosis (ABPA)
* Previous lung transplantation procedure.
C: 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
D: Inclusion Criteria:

* CF as diagnosed by:

  1. Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or
  2. Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
  3. Abnormal nasal potential difference with accompanying symptoms characteristic of CF.
* PA present in expectorated sputum or throat swab culture at Screening.
* Participants must have received three or more courses of TIS within the previous 12 months.
* Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.
* Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening.
* Ability to perform reproducible pulmonary function tests.
* Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.

Exclusion Criteria:

* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day.
* History of sputum or throat culture swab yielding Burkholderia cepacia in the past 2 years.
* History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
* Administration of any investigational drug or device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer).
* Known local or systemic hypersensitivity to monobactam antibiotics.
* Inability to tolerate inhalation of a short acting Beta-2 agonist.
* Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit.
* Changes in physiotherapy technique or schedule within 7 days before Screening or between Screening and the next visit.
* History of lung transplantation.
* A chest X-ray indicating abnormal findings at Screening or within the previous 90 days.
* Abnormal renal or hepatic function or serum chemistry at Screening (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] greater than 5 times the upper limit of normal range; Creatinine greater than 2 times the upper limit of normal range).
* Positive pregnancy test at Screening.
* Female of childbearing potential who was lactating or in the opinion of the investigator was not practicing acceptable birth control.
* Any serious or active medical or psychiatric illness, which in the opinion of the investigator would have interfered with participant treatment, assessment, or compliance with the protocol.

Answer: C