AsthmaNCT00660569
Utilization Patterns of Pulmicort in Real Life Practice
An observational study of Asthma, run by AstraZeneca at 10 sites in Spain.
Trial summary
The purpose of this study is to identify the potential issues during short and mid term utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and describe associated factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 260 participants
- Where
- 10 sitesSpain
- Study dates
- Jan 2008to Feb 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population treated by General Practitioner, Pneumologists or Paediatricians
Who may be able to join
- Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion
- Patients previously treated with Pulmicort CFC who have changed their treatment to Pulmicort HFA
Who cannot join
- Disability that, from investigator point of view, prevent from complying the follow up schedule
- To have participated in any clinical study in the past 6 months
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Research Site
Alcorcón, Madrid
Research Site
Barcelona, Barcelona
Research Site
Fuentes de Ebro, Zaragoza
Research Site
Leganés, Madrid
Research Site
Madrid, Madrid
Research Site
Murcia, Murcia
Research Site
Olivares, Sevilla
Research Site
Sabadell, Barcelona
Research Site
San Sebastián de los Reyes, Madrid
Research Site
Toledo, Toledo
About this study
Official title: Utilization Patterns of Pulmicort HFA in Real Life Practice
The purpose of this study is to identify the potential issues during short and mid term utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and describe associated factors.
- Conditions
- Asthma
- Keywords
- asthma treatment, utilization, real life practice
- Medical subject headings
- Asthma, Patient Acceptance of Health Care
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 |
|---|---|---|
| 1 | Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion, previously treated with Pulmicort chlorofluorocarbons (CFC) who have changed their treatment to Pulmicort HFA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJan 2008
- Study completionFeb 2009
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javier Nuevo Rivero, Study director, AstraZeneca MC SpainEpidemiologyValue Demonstration Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660569
- Sponsor's protocol ID
- NIS-RES-PUL-2007/1
- Status last verified
- Nov 2010
- First submitted
- 15 Apr 2008
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization Patterns of Pulmicort HFA in Real Life Practice
- ClinicalTrials.gov ID
- NCT00660569
- Acronym / sponsor ID
- NIS-RES-PUL-2007/1
- Conditions
- Asthma
- Keywords
- asthma treatment, utilization, real life practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Apr 2008 (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 purpose of this study is to identify the potential issues during short and mid term utilization of Pulmicort hydro fluoroaklane (HFA) pressurized metered-dose inhaler (pMDI)and describe associated factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion, previously treated with Pulmicort chlorofluorocarbons (CFC) who have changed their treatment to Pulmicort HFA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population treated by General Practitioner, Pneumologists or Paediatricians
Key inclusion criteria (2 listed)
- Asthmatic patients with a diagnose of at least 12 months of duration before study inclusion
- Patients previously treated with Pulmicort CFC who have changed their treatment to Pulmicort HFA
Key exclusion criteria (2 listed)
- Disability that, from investigator point of view, prevent from complying the follow up schedule
- To have participated in any clinical study in the past 6 months
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
Not reported in the source record.
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 1 Dec 2010.
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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.
Javier Nuevo Rivero study director
AstraZeneca MC SpainEpidemiologyValue Demonstration Unit
10 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, run by AstraZeneca at 10 sites in Spain.
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 2 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 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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.
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 1 Dec 2010.