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Completed

NCT Number: NCT01424137

Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

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).

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Key information

Conditions

Asthma Bronchial Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lasnamäe Medicum, Tallinn, Estonia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Easyhaler type A

Device

Easyhaler type A inhaler, 3 consecutive inhalations

Other names: SF EH (D94-2SF)

Easyhaler type B

Device

Easyhaler type B inhaler, 3 consecutive inhalations

Other names: SF EH (D94-2SF-B)

Diskus inhaler

Device

Diskus inhaler, 3 consecutive inhalations

Other names: Inhaler for Seretide Diskus

Primary outcomes

  1. Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers

    Time frame: 1 day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Acronym: SALIF

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2011
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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