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Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF) (SALIF)

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ClinicalTrials.gov Identifier: NCT01424137
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler® (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children, adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Device: Easyhaler type A Device: Easyhaler type B Device: Diskus inhaler Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD
Study Start Date : September 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Easyhaler type A Device: Easyhaler type A
Easyhaler type A inhaler, 3 consecutive inhalations
Other Name: SF EH (D94-2SF)
Easyhaler type B Device: Easyhaler type B
Easyhaler type B inhaler, 3 consecutive inhalations
Other Name: SF EH (D94-2SF-B)
Diskus inhaler Device: Diskus inhaler
Diskus inhaler, 3 consecutive inhalations
Other Name: Inhaler for Seretide Diskus



Primary Outcome Measures :
  1. Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate [ Time Frame: 1 day ]


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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent (IC) obtained
  • Documented diagnosis of asthma and/or COPD
  • Age: 4 years and above

Exclusion Criteria:

  • Any severe chronic respiratory disease other than asthma or COPD
  • Acute respiratory infection
  • Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study

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): NCT01424137


Locations
Estonia
Lasnamäe Medicum
Tallinn, Estonia, 13619
Children's Clinic of Tartu, Allergy Centre
Tartu, Estonia, 51014
Tartu University Hospital, Lung Clinic
Tartu, Estonia, 51014
Finland
Jorvi Hospital HUS
Espoo, Finland, 02740
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Kati Kaijasilta Orion Corporation, Orion Pharma

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01424137     History of Changes
Other Study ID Numbers: 3106002
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases