NCT00984906

Brief Summary

The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable asthma

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

6 months

First QC Date

September 23, 2009

Last Update Submit

June 7, 2010

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers

    1 Day

Secondary Outcomes (3)

  • Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.

    1 Day

  • Handling of the devices in the subpopulation of asthmatic children

    1 Day

  • Acceptability of the inhalers in the subpopulation of asthmatic children

    1 Day

Study Arms (3)

Empty Easyhaler type A

OTHER
Other: Empty inhalers

Empty Easyhaler type B

OTHER
Other: Empty inhalers

Empty Turbohaler

OTHER
Other: Empty inhalers

Interventions

Empty inhalersOTHER

Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler

Also known as: Empty device-metered dry powder inhaler Easyhaler (type A), Empty device-metered dry powder inhaler Easyhaler (type B), Empty device-metered dry powder inhaler Turbohaler
Empty Easyhaler type AEmpty Easyhaler type BEmpty Turbohaler

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent obtained.
  • Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
  • Age: 6 years or above.

You may not qualify if:

  • Any severe chronic respiratory disease other than asthma or COPD.
  • Acute respiratory infection.
  • Concurrent participation in a clinical drug study.
  • Inability to perform repeatable spirometric measurements.
  • Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jorvi hospital

Helsinki, Finland

Location

Skin and Allergy hospital

Helsinki, Finland

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Satu Lähelmä, M.Sc.(Pharm)

    Orion Corporation, Orion Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 25, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations

FI(2)GB(2)