Peripheral targeting of inhaled rhDNase in stable CF patients.

Peripheral targeting of inhaled rhDNase in stable CF patients. - PIPES-study (Pulmozyme Inhalation to the PEripheral airways in Stable CF.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33580

Enrollment

Registered

2007-03-26

Start date

2007-09-21

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis (CF)

Interventions

Nebulization of rhDNase targeted to the peripheral airways, using the Akita nebulizer.

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: The criteria of inclusion will be the following: - Age between 6 and 18 years old; - Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement); - Routine treatment with rhDNase once daily, started at least one month before enrolment in the study; - Stable condition, in this study defined as: condition of patient judged to be stable by the treating physician AND no i.v antibiotics (hospital or at home) in the previous month and constant medication regime during the previous 2 weeks (for example: no additional antibiotics course, no newly started inhaled or systemic corticosteroids etc). - Ability to perform lung function tests (assessed by trained lung function technician); - Lung function: FVC > 40% predicted; - Signed written informed consent.

Exclusion criteria

Exclusion criteria: The following exclusion criteria will be used: - Inability to follow instructions of the investigator; - Inability to inhale rhDNase; - Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe malacia); - Current respiratory tract infection; - Pulmonary complications that might put the patient at risk to participate in the study; - Neuromuscular disease; - Poor compliance with treatment as assessed by the patient*s paediatrician; - Active ABPA (allergic bronchopulmonary aspergillosis) defined as an oral course of prednisone for ABPA within the last three months.

Design outcomes

Primary

Measure	Time frame
Primary endpoint will be the change in FEF75 compared to baseline after one month of treatment. FEF75 is the most suitable endpoint since it is sensitive to peripheral airways obstruction.	—

Secondary

Measure	Time frame
Secondary endpoints will include: Lung clearance index (LCI) measurements as assessed by multiple breath washout; Other values obtained in the flow volume curve: MMEF25-75, FEV1, FVC. Other study parameters, such as use of antibiotics and number of exacerbations (if applicable)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)