Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

NCT ID: NCT01424137

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Asthma Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Easyhaler type A

Group Type OTHER

Easyhaler type A

Intervention Type DEVICE

Easyhaler type A inhaler, 3 consecutive inhalations

Easyhaler type B

Group Type OTHER

Easyhaler type B

Intervention Type DEVICE

Easyhaler type B inhaler, 3 consecutive inhalations

Diskus inhaler

Group Type OTHER

Diskus inhaler

Intervention Type DEVICE

Diskus inhaler, 3 consecutive inhalations

Interventions

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Easyhaler type A

Easyhaler type A inhaler, 3 consecutive inhalations

Intervention Type DEVICE

Easyhaler type B

Easyhaler type B inhaler, 3 consecutive inhalations

Intervention Type DEVICE

Diskus inhaler

Diskus inhaler, 3 consecutive inhalations

Intervention Type DEVICE

Other Intervention Names

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SF EH (D94-2SF) SF EH (D94-2SF-B) Inhaler for Seretide Diskus

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kati Kaijasilta

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

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Lasnamäe Medicum

Tallinn, , Estonia

Site Status

Children's Clinic of Tartu, Allergy Centre

Tartu, , Estonia

Site Status

Tartu University Hospital, Lung Clinic

Tartu, , Estonia

Site Status

Jorvi Hospital HUS

Espoo, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Countries

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Estonia Finland

References

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Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3.

Reference Type DERIVED
PMID: 38170393 (View on PubMed)

Other Identifiers

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3106002

Identifier Type: -

Identifier Source: org_study_id

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