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

February 2, 2012 updated by: Orion Corporation, Orion Pharma

Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia, 13619
        • Lasnamäe Medicum
      • Tartu, Estonia, 51014
        • Children's Clinic of Tartu, Allergy Centre
      • Tartu, Estonia, 51014
        • Tartu University Hospital, Lung Clinic
  • Finland
      • Espoo, Finland, 02740
        • Jorvi Hospital HUS
      • Turku, Finland, 20520
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Easyhaler type A
Device: Easyhaler type A
Easyhaler type A inhaler, 3 consecutive inhalations
Other Names:
  • SF EH (D94-2SF)
Other: Easyhaler type B
Device: Easyhaler type B
Easyhaler type B inhaler, 3 consecutive inhalations
Other Names:
  • SF EH (D94-2SF-B)
Other: Diskus inhaler
Device: Diskus inhaler
Diskus inhaler, 3 consecutive inhalations
Other Names:
  • Inhaler for Seretide Diskus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Kati Kaijasilta, Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3106002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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