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

June 7, 2010 updated by: Orion Corporation, Orion Pharma

Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre Study in Patients With Asthma or COPD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Jorvi Hospital
      • Helsinki, Finland
        • Skin and Allergy hospital
  • United Kingdom
      • Sheffield, United Kingdom
        • Northern General Hospital
      • Sheffield, United Kingdom
        • Sheffield Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Empty Easyhaler type A
Other: Empty inhalers
Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler
Other Names:
  • Empty device-metered dry powder inhaler Easyhaler (type A)
  • Empty device-metered dry powder inhaler Easyhaler (type B)
  • Empty device-metered dry powder inhaler Turbohaler
Other: Empty Easyhaler type B
Other: Empty inhalers
Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler
Other Names:
  • Empty device-metered dry powder inhaler Easyhaler (type A)
  • Empty device-metered dry powder inhaler Easyhaler (type B)
  • Empty device-metered dry powder inhaler Turbohaler
Other: Empty Turbohaler
Other: Empty inhalers
Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler
Other Names:
  • Empty device-metered dry powder inhaler Easyhaler (type A)
  • Empty device-metered dry powder inhaler Easyhaler (type B)
  • Empty device-metered dry powder inhaler Turbohaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

Outcome Measure
Time Frame
Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.
Time Frame: 1 Day
1 Day
Handling of the devices in the subpopulation of asthmatic children
Time Frame: 1 Day
1 Day
Acceptability of the inhalers in the subpopulation of asthmatic children
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Satu Lähelmä, M.Sc.(Pharm), Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 7, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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