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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01424137
First Posted: August 26, 2011
Last Update Posted: February 3, 2012
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.
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
  Purpose
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 Intervention
Asthma Chronic Obstructive Pulmonary Disease Device: Easyhaler type A Device: Easyhaler type B Device: Diskus inhaler

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 227
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01424137     History of Changes
Other Study ID Numbers: 3106002
First Submitted: August 24, 2011
First Posted: August 26, 2011
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