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Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life

NCT ID: NCT01749644

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler

Keywords

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Cystic Fibrosis, Chronic Pseudomonas Infection, Inhaled Tobramycin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CF patients with chronic pseudomonas infection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 6 years and above, Chronic Pseudomonas infection

Exclusion Criteria

* Younger than 6 years; No chronic PSeudomonas infection
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ori Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Safra Children's hospital, National CF Center

Ifat Sarouk, MD

Role: PRINCIPAL_INVESTIGATOR

Safra Children's Hospital, National CF center

Locations

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Safra Children's Hospital, Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ori Sarouk, MD

Role: CONTACT

Phone: 97235302884

Email: [email protected]

Facility Contacts

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Ifat Sarouk, MD

Role: primary

Other Identifiers

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SHEBA-12-9640-OE-CTIL

Identifier Type: -

Identifier Source: org_study_id