AsthmaPIFECONCT00984906
Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers
A study testing Empty inhalers in people with Asthma and Pulmonary Disease, Chronic Obstructive, run by Orion Corporation, Orion Pharma at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Empty inhalers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
- Age: 6 years or above.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom2 sites
Northern General Hospital
Sheffield
Sheffield Children's Hospital
Sheffield
About this study
Official title: Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre Study in Patients With Asthma or COPD
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.
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Being tested
- Empty inhalers
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empty inhalersOther
Also called 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 inhalers (type A and type B) and empty Turbohaler inhaler
| Study group | Role | What they receive |
|---|---|---|
| Empty Easyhaler type A | Other | Not described Receives: Other: Empty inhalers |
| Empty Easyhaler type B | Other | Not described Receives: Other: Empty inhalers |
| Empty Turbohaler | Other | Not described Receives: Other: Empty inhalers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
Measured: 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.
Measured: 1 Day
Handling of the devices in the subpopulation of asthmatic children
Measured: 1 Day
Acceptability of the inhalers in the subpopulation of asthmatic children
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Satu Lähelmä, M.Sc.(Pharm), Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984906
- Sponsor's protocol ID
- 3103003
- Acronym
- PIFECO
- Status last verified
- Jun 2010
- First submitted
- 23 Sep 2009
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre Study in Patients With Asthma or COPD
- ClinicalTrials.gov ID
- NCT00984906
- Acronym / sponsor ID
- PIFECO / 3103003
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empty Easyhaler type A | Other | Other: Empty inhalers |
| Empty Easyhaler type B | Other | Other: Empty inhalers |
| Empty Turbohaler | Other | Other: Empty inhalers |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent obtained.
- Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
- Age: 6 years or above.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empty inhalersAlso: Empty device-metered dry powder inhaler Easyhaler (type A), Empty device-metered dry powder inhaler Easyhaler (type B), Empty device-metered dry powder inhaler TurbohalerEmpty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler | Other | Empty Easyhaler type A, Empty Easyhaler type B, Empty Turbohaler |
Primary outcome
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
Time frame: 1 Day
3 secondary outcomes
Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.
Time frame: 1 Day
Handling of the devices in the subpopulation of asthmatic children
Time frame: 1 Day
Acceptability of the inhalers in the subpopulation of asthmatic children
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satu Lähelmä, M.Sc.(Pharm) study director
Orion Corporation, Orion Pharma
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empty inhalers in people with Asthma and Pulmonary Disease, Chronic Obstructive, run by Orion Corporation, Orion Pharma at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.