Evaluation of CF Patient Perception of Symptom Improvement Following Inhaled Antibiotic Treatment
- Conditions
- Cystic Fibrosis (CF)Human Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12605000602628
- Lead Sponsor
- Corus Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Diagnosis of CF and chronic PA infection (defined as cultures positive for PA for > 6 months, including most recent culture). Have adequate understanding of English to give informed consent and follow study procedures. Patient must have completed their most recent course of TOBI or aerosolized tobramycin solution or any other aerosolized antibiotic at least 28 days prior to study entry. Parent/guardian of children 6 to 13 years old must agree to complete the CFQ-R and Global Rating of Change Questionnaires. Patient's physician must have decided to prescribe a 28 day course of TOBI for treatment of clinical symptoms (increased cough, increased sputum production/chest congestion, decreased exercise tolerance, or decreased appetite).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the responsiveness of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) by determination of the minimal clinically important difference score (MCID) in children/parents and adolescents/adults with CF receiving Tobramycin solution for inhalation (TOBI).[Measured upon completion of a 28 day course of Tobramycin, and again 14 days post completion.]
- Secondary Outcome Measures
Name Time Method To correlate change in clinical symptoms as measured by the CFQ-R with change in pulmonary function and the Global Rating of Change Questionnaire.[This will be measured upon completion of a 28 day course of Tobramycin, and again 14 days post completion.]