A Novel Assay to Quantify Treatment Response in Cystic Fibrosis (CF)

Plain-language summary

This study evaluates a new laboratory test to measure how patients with cystic fibrosis (CF) respond to treatment. It enrolled CF patients aged 18 and older who were starting treatment for a lung flare-up (pulmonary exacerbation). It was carried out as a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Milene Saavedra

Start date

5/1/2011

Estimated completion

1/1/2018

Countries

United States

Related genes

Locations

• Denver, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Documented diagnosis of CF.
2. Age 18 years old or greater.
3. Presentation at the start of treatment for a pulmonary exacerbation of CF.
4. Ability to perform reproducible Pulmonary Function Tests and produce sputum.
5. Willingness to comply with study procedure and willingness to provide written consent.

Exclusion Criteria:

1. Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
2. Use of systemic steroids