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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00984906
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Pulmonary Disease, Chronic Obstructive Other: Empty inhalers Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers [ Time Frame: 1 Day ]

Secondary Outcome Measures :
  1. 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 ]
  2. Handling of the devices in the subpopulation of asthmatic children [ Time Frame: 1 Day ]
  3. Acceptability of the inhalers in the subpopulation of asthmatic children [ Time Frame: 1 Day ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984906


Locations
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Finland
Jorvi hospital
Helsinki, Finland
Skin and Allergy hospital
Helsinki, Finland
United Kingdom
Northern General Hospital
Sheffield, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Satu Lähelmä, M.Sc.(Pharm) Orion Corporation, Orion Pharma
More Information
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Responsible Party: Satu Lähelmä/Clinical Study Director, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00984906    
Other Study ID Numbers: 3103003
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: June 2010
Additional relevant MeSH terms:
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Asthma
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases