Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler Clinical Trial
Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | January 2015 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years and older |
| Eligibility |
Inclusion Criteria: - Age 6 years and above, Chronic Pseudomonas infection Exclusion Criteria: - Younger than 6 years; No chronic PSeudomonas infection |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Safra Children's Hospital, Sheba Medical Center | Ramat Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in quality of life | 1 year | No | |
| Secondary | Difference in exacerbation events | To be measured by: Worsening of CF symptoms such as coughing, sputum, deterioration in FEV1, all of which require hospitalization |
1 year | No |