Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01424137
First received: August 24, 2011
Last updated: February 2, 2012
Last verified: February 2012
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424137

Locations
Estonia
Lasnamäe Medicum
Tallinn, Estonia, 13619
Tartu University Hospital, Lung Clinic
Tartu, Estonia, 51014
Children's Clinic of Tartu, Allergy Centre
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

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01424137     History of Changes
Other Study ID Numbers: 3106002
Study First Received: August 24, 2011
Last Updated: February 2, 2012
Health Authority: Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on April 16, 2014