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OpenTrials
Completed

NCT Number: NCT00984906

Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers

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.

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Key information

Conditions

Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jorvi hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Empty inhalers

Other

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

Primary outcomes

  1. Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers

    Time frame: 1 Day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study 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

Acronym: PIFECO

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 25, 2009
Registry last updated
Jun 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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