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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00984906
Other study ID # 3103003
Secondary ID
Status Completed
Phase N/A
First received September 23, 2009
Last updated June 7, 2010
Start date September 2009
Est. completion date March 2010

Study information

Verified date June 2010
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Empty inhalers
Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler

Locations

Country Name City State
Finland Jorvi hospital Helsinki
Finland Skin and Allergy hospital Helsinki
United Kingdom Northern General Hospital Sheffield
United Kingdom Sheffield Children's Hospital Sheffield

Sponsors (1)

Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Finland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers 1 Day No
Secondary Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate. 1 Day No
Secondary Handling of the devices in the subpopulation of asthmatic children 1 Day No
Secondary Acceptability of the inhalers in the subpopulation of asthmatic children 1 Day No
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