Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers (PIFECO)

Orion Pharma

Status: Completed

Conditions: Asthma; Pulmonary Disease, Chronic Obstructive

Treatments: Other: Empty inhalers

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984906

3103003

Details and patient eligibility

About

The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.

Enrollment: 200 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained.
• Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
• Age: 6 years or above.

Exclusion criteria

• Any severe chronic respiratory disease other than asthma or COPD.
• Acute respiratory infection.
• Concurrent participation in a clinical drug study.
• Inability to perform repeatable spirometric measurements.
• Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).

Trial design

200 participants in 3 patient groups

Empty Easyhaler type A

Other group

Treatment:

Other: Empty inhalers

Empty Easyhaler type B

Other group

Treatment:

Other: Empty inhalers

Empty Turbohaler

Other group

Treatment:

Other: Empty inhalers