AsthmaPhase 4NCT01449123
Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations
A Phase 4 study testing Mannitol challenge test & reversibility test in people with Asthma, run by Mundipharma AB at 1 site in Sweden.
Trial summary
The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Mannitol challenge test & reversibility test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Apr 2012
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age 18-65 years.
- Subjects diagnosed with asthma.
- Subjects with a baseline FEV1 of ≥70% of the predicted value.
- Outpatients at primary clinic.
- Subjects treated with a fixed dose combination for at least the last three months.
- Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
- Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.
Who cannot join
- Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
- Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
- Any history of hypersensitivity to mannitol challenge test.
- Any contraindications to use of the diagnostic study medication.
- Subjects who are unsuitable for other reason(s) in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Single Site Single Dose Pilot Study Using Mannitol Challenge Test With the Purpose to Explore Treatment With Fixed Dose Combinations in Adult Subjects With Asthma in Primary Care in Sweden
The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test.
The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test.
The hypothesis is that not all patients are well treated.
- Conditions
- Asthma
- Being tested
- Mannitol challenge test & reversibility test
- Keywords
- Asthma, mannitol challenge test, Sweden, primary care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol challenge test & reversibility testDrug
Patients perform an asthma control test (ACT) to establish if they are "well controlled" or "symptomatic". All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness
| Study group | Role | What they receive |
|---|---|---|
| Inhaler | Experimental | Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once Receives: Drug: Mannitol challenge test & reversibility test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response.
For the Primary efficacy variable, positive response Mannitol challenge test (Aridol™) followed by short-acting β2-agonist will be given as number and percentage for the ITT-population, as defined by the following: ≥15% fall in FEV1 from baseline; 10% incremental fall in FEV1 between two consecutive doses in the test; Reversibility test with a short-acting β2-agonist - increase in FEV1 of ≥15% from the last dose of mannitol in the challenge test.
Measured: One day only (Day 1). Subjects complete an ACT, the mannitol challenge test and the reversibility test. This is the end of the study, there is no follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionApr 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449123
- Sponsor's protocol ID
- FLT4501
- Other IDs
- 2011-000939-86
- Status last verified
- Aug 2012
- First submitted
- 8 Sep 2011
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single Site Single Dose Pilot Study Using Mannitol Challenge Test With the Purpose to Explore Treatment With Fixed Dose Combinations in Adult Subjects With Asthma in Primary Care in Sweden
- ClinicalTrials.gov ID
- NCT01449123
- Acronym / sponsor ID
- FLT4501
- Conditions
- Asthma
- Keywords
- Asthma, mannitol challenge test, Sweden, primary care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Mundipharma ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Oct 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 primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test.
The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test.
The hypothesis is that not all patients are well treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaler | Experimental | Drug: Mannitol challenge test & reversibility testSubjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females, age 18-65 years.
- Subjects diagnosed with asthma.
- Subjects with a baseline FEV1 of ≥70% of the predicted value.
- Outpatients at primary clinic.
- Subjects treated with a fixed dose combination for at least the last three months.
Key exclusion criteria (5 listed)
- Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
- Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
- Any history of hypersensitivity to mannitol challenge test.
- Any contraindications to use of the diagnostic study medication.
- Subjects who are unsuitable for other reason(s) in the opinion of the investigator.
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 |
|---|---|---|
| Mannitol challenge test & reversibility testPatients perform an asthma control test (ACT) to establish if they are "well controlled" or "symptomatic". All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness | Drug | Inhaler |
Primary outcome
Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response.
Time frame: One day only (Day 1). Subjects complete an ACT, the mannitol challenge test and the reversibility test. This is the end of the study, there is no follow up.
For the Primary efficacy variable, positive response Mannitol challenge test (Aridol™) followed by short-acting β2-agonist will be given as number and percentage for the ITT-population, as defined by the following: ≥15% fall in FEV1 from baseline; 10% incremental fall in FEV1 between two consecutive doses in the test; Reversibility test with a short-acting β2-agonist - increase in FEV1 of ≥15% from the last dose of mannitol in the challenge test.
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 9 Aug 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mannitol challenge test & reversibility test in people with Asthma, run by Mundipharma AB at 1 site in Sweden.
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 7 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response. (time frame: One day only (Day 1). Subjects complete an ACT, the mannitol challenge test and the reversibility test. This is the end of the study, there is no follow up.). 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 9 Aug 2012.