AsthmaNCT02811315
Flutiform in Treatment of Patients With Asthma in Daily Clinical Practice.
An observational study of Asthma, run by Mundipharma Pharmaceuticals B.V..
Trial summary
The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Observational. Non interventional study
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 15 Dec 2016
- 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: Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows: Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist. The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study.
Who may be able to join
- Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows:
- Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist.
- The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study
Who cannot join
- There are no specific exclusion criteria as this is an observational study
About this study
Official title: Flutiform Treatment in Patients With Asthma in Daily Clinical Practice; a Prospective Observational Non-interventional Study Assessing the Effect of Space Use and Adherence on Fluticasone/Formoterol FDC Efficacy Measured With the Asthma Control Questionnaire (ACQ-6).
The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.
- Conditions
- Asthma
- Being tested
- Observational. Non interventional study
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational. Non interventional studyOther
Observational. Non interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice
the Asthma Control Questionnaire will be completed by subjects at study baseline and then after 12 weeks of treatment. Difference between the 2 will be the primary endpoint.
Measured: This measurement will be taken after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016 (estimated)
- Primary completion15 Dec 2016 (estimated)
- Study completion15 Dec 2016 (estimated)
Why it stopped: Lack of interest
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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Pharmaceuticals B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811315
- Sponsor's protocol ID
- FLT9509
- Status last verified
- Nov 2018
- First submitted
- 21 Jun 2016
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flutiform Treatment in Patients With Asthma in Daily Clinical Practice; a Prospective Observational Non-interventional Study Assessing the Effect of Space Use and Adherence on Fluticasone/Formoterol FDC Efficacy Measured With the Asthma Control Questionnaire (ACQ-6).
- ClinicalTrials.gov ID
- NCT02811315
- Acronym / sponsor ID
- FLT9509
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mundipharma Pharmaceuticals B.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (estimated)
- Primary completion
- 15 Dec 2016 (estimated)
- Study completion
- 15 Dec 2016 (estimated)
- First posted
- 23 Jun 2016 (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 objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows: Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist. The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study.
Key inclusion criteria (3 listed)
- Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows:
- Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist.
- The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria as this is an observational study
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 |
|---|---|---|
| Observational. Non interventional studyObservational. Non interventional study | Other | – |
Primary outcome
Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice
Time frame: This measurement will be taken after 12 weeks of treatment
the Asthma Control Questionnaire will be completed by subjects at study baseline and then after 12 weeks of treatment. Difference between the 2 will be the primary endpoint.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Mundipharma Pharmaceuticals B.V..
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 1 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: withdrawn, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the effect of frequency of spacer use on asthma control in patients in normal clinical practice (time frame: This measurement will be taken after 12 weeks of treatment). 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 16 Nov 2018.