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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00984906
First received: September 23, 2009
Last updated: June 7, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Asthma
Pulmonary Disease, Chronic Obstructive
 Other: Empty inhalers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Handling of the devices in the subpopulation of asthmatic children [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Acceptability of the inhalers in the subpopulation of asthmatic children [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984906

Locations
Finland
Skin and Allergy hospital
Helsinki, Finland
Jorvi hospital
Helsinki, Finland
United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Satu Lähelmä, M.Sc.(Pharm) Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: Satu Lähelmä/Clinical Study Director, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00984906     History of Changes
Other Study ID Numbers: 3103003
Study First Received: September 23, 2009
Last Updated: June 7, 2010
Health Authority: Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Respiratory Aspiration
Asthma
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013