AsthmaANASANCT01475045
ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.
Trial summary
The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- How many people
- 1,160 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2011to Sep 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three subgroups of patients who are already in their inhalation treatment (devices: Discus, Elpenhaler, Turbuhaler) are asked to complete the FSI-10 questionnaire valid in Greek language. The questionnaire responses indicate their satisfaction by their treatment devices.
Who may be able to join
- Patients > 18 years old, both genders who are on their inhalation treatment at least two months before study enrollment,
- Who are able to be compliant to study procedures
Who cannot join
- Patients < 18 years old,
- Patients who are on their inhalation treatment less than two months before study enrollment
- Patients who are not able to be compliant to study procedures
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
7th Pulmonary Clinic, Sotiria Hospital
Athens
Sotiria Hospital
Athens
About this study
Official title: Multicenter, Prospective, Non Interventional Observational Study in Treatments of Asthma and Chronic Obstructive Pulmonary Disease (COPD)
The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire
Read the detailed description
Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler)
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Turbuhaler inhaler use | Not described | |
| Discus inhaler use | Not described | |
| Elpenhaler inhaler use | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' satisfaction
Patients' replies to FSI-10 questionnaire valid in Greek language
Measured: all study period (5 months)
Secondary outcomes (1)
Patients devices' use
Measured: all study period (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionSep 2011
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asimina Gaga, Principal investigator, 7th Pulmonary Clinic, Sotiria Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475045
- Sponsor's protocol ID
- 20109-HAL-EL-02
- Other IDs
- Sponsor ID
- Acronym
- ANASA
- Status last verified
- Nov 2011
- First submitted
- 12 Oct 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Non Interventional Observational Study in Treatments of Asthma and Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01475045
- Acronym / sponsor ID
- ANASA / 20109-HAL-EL-02
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Nov 2011 (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 compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire
Detailed description
Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler)
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Turbuhaler inhaler use | – | – |
| Discus inhaler use | – | – |
| Elpenhaler inhaler use | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three subgroups of patients who are already in their inhalation treatment (devices: Discus, Elpenhaler, Turbuhaler) are asked to complete the FSI-10 questionnaire valid in Greek language. The questionnaire responses indicate their satisfaction by their treatment devices.
Key inclusion criteria (2 listed)
- Patients > 18 years old, both genders who are on their inhalation treatment at least two months before study enrollment,
- Who are able to be compliant to study procedures
Key exclusion criteria (3 listed)
- Patients < 18 years old,
- Patients who are on their inhalation treatment less than two months before study enrollment
- Patients who are not able to be compliant to study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients' satisfaction
Time frame: all study period (5 months)
Patients' replies to FSI-10 questionnaire valid in Greek language
1 secondary outcome
Patients devices' use
Time frame: all study period (5 months)
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 21 Nov 2011.
- study design presented in European Respiratory Congress (2 thematric posters)Link provided by the sponsor.
- FSI-10 questionnaire has been translated and is valid in Greek language (full article)Link provided by the sponsor.
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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.
Asimina Gaga principal investigator
7th Pulmonary Clinic, Sotiria Hospital of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.
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 2 inclusion and 3 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 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Patients' satisfaction (time frame: all study period (5 months)). 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 21 Nov 2011.