N/A
Completed N=267
Early Intervention in Cystic Fibrosis Exacerbation
Source: ClinicalTrials.gov NCT01104402 ↗Enrolled (actual)
267
Serious AEs
2.6%
Results posted
Oct 2017
Primary outcomePrimary: Change in FEV1 — -0.07; -0.08 Liters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in FEV1 |
-0.07; -0.08 | — |
| SECONDARY Cystic Fibrosis Respiratory Symptom Diary (CFRSD) |
4.56; 0.45 | — |
| SECONDARY Pulmonary Exacerbations |
70; 75 | — |
| SECONDARY Change in Health Related Quality of Life Scores as Assessed by the Cystic Fibrosis Questionnaire Revised (CFQ-R) (Respiratory Subscale Only( |
-3.07; -.44 | — |
| SECONDARY Treatment Burden |
0.6; 2.9 | — |
| SECONDARY Change in Prevalence of Resistant Species of Bacteria |
3; 8 | — |
| SECONDARY Serious Adverse Events (SAE) |
0.023; 0.030 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01104402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.