Asthma BronchialePhase 3NCT00563056
An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
A Phase 3 study testing Flutiform and Flixotide plus Foradil in people with Asthma Bronchiale, run by Mundipharma Research Limited at 6 sites in 6 countries.
Trial summary
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- Flutiform and Flixotide plus Foradil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Sep 2007to Apr 2008
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects at least 12 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study if they are sexually active. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
- Known history of mild to moderate-severe persistent, reversible asthma for ≥ 6 months prior to the screening visit.
- Demonstrate a FEV1 of ≥40% to ≤85% for predicted normal values (Quanjer et al, 19931) during the screening phase following appropriate withholding of asthma medications (if applicable).
- No β2-agonist use on day of screening.
- No use of inhaled combination asthma therapy on day of screening.
- Inhaled corticosteroids are allowed on day of screening.
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- Documented reversibility of ≥15% in FEV1 in the screening phase.
- Demonstrate satisfactory technique in the use of the study medications.
- Willing and able to enter information in the diary and attend all study visits.
- Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
- Written informed consent obtained
Who cannot join
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Hospitalization or an emergency visit for asthma within the past year.
- History of systemic (oral or parenteral) corticosteroid medication within 1 month before the Screening Visit.
- History of omalizumab use within the past 6 months.
- History of leukotriene receptor antagonist use, e.g. montelukast, or theophylline within the past week.
- Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study.
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- In the investigators opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
- Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
- Known Human Immunodeficiency Virus (HIV)-positive status.
- A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
- Current smoking history within 12 months prior to the Screening Visit.
- Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
- Subjects who have taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
- Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
- Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
- Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
- Current participation in a clinical study
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
Read the detailed description
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
- Conditions
- Asthma Bronchiale
- Being tested
- Flutiform, Flixotide plus Foradil
- Keywords
- Formoterol, Fluticasone, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlutiformDrug
Flixotide plus ForadilDrug
| Study group | Role | What they receive |
|---|---|---|
| Flutiform | Experimental | 2 puffs 50/5 or 125/5 mcg Receives: Drug: Flutiform |
| Flixotide plus Foradil | Active comparator | Flixotide 2 puffs 50 or 125 mcg; Foradil 1 puff 12 mcg Receives: Drug: Flixotide plus Foradil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
Measured: 12 weeks
Secondary outcomes (1)
Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma BronchialeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563056
- Sponsor's protocol ID
- FLT3505
- Other IDs
- 2007-001634-13
- Status last verified
- Oct 2018
- First submitted
- 21 Nov 2007
- Last updated
- 24 Oct 2018
- Results posted
- No
Publications
Bodzenta-Lukaszyk A, van Noord J, Schroder-Babo W, McAulay K, McIver T. Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial. Curr Med Res Opin. 2013 May;29(5):579-88. doi: 10.1185/03007995.2013.772506. Epub 2013 Feb 20.
PubMed 23368897
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
- ClinicalTrials.gov ID
- NCT00563056
- Acronym / sponsor ID
- FLT3505
- Conditions
- Asthma Bronchiale
- Keywords
- Formoterol, Fluticasone, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Nov 2007 (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.
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
Detailed description
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flutiform | Experimental | Drug: Flutiform2 puffs 50/5 or 125/5 mcg |
| Flixotide plus Foradil | Active comparator | Drug: Flixotide plus ForadilFlixotide 2 puffs 50 or 125 mcg; Foradil 1 puff 12 mcg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects at least 12 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study if they are sexually active. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
- Known history of mild to moderate-severe persistent, reversible asthma for ≥ 6 months prior to the screening visit.
- Demonstrate a FEV1 of ≥40% to ≤85% for predicted normal values (Quanjer et al, 19931) during the screening phase following appropriate withholding of asthma medications (if applicable).
- Documented reversibility of ≥15% in FEV1 in the screening phase.
- Demonstrate satisfactory technique in the use of the study medications.
Key exclusion criteria (17 listed)
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Hospitalization or an emergency visit for asthma within the past year.
- History of systemic (oral or parenteral) corticosteroid medication within 1 month before the Screening Visit.
- History of omalizumab use within the past 6 months.
- History of leukotriene receptor antagonist use, e.g. montelukast, or theophylline within the past week.
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 |
|---|---|---|
| Flutiform | Drug | Flutiform |
| Flixotide plus Foradil | Drug | Flixotide plus Foradil |
Primary outcome
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
Time frame: 12 weeks
1 secondary outcome
Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance
Time frame: 12 weeks
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 24 Oct 2018.
- Derived from this study: PubMed 23368897Bodzenta-Lukaszyk A, van Noord J, Schroder-Babo W, McAulay K, McIver T. Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial. Curr Med Res Opin. 2013 May;29(5):579-88. doi: 10.1185/03007995.2013.772506. Epub 2013 Feb 20.
- Results available on registerLink 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutiform and Flixotide plus Foradil in people with Asthma Bronchiale, run by Mundipharma Research Limited at 6 sites in 6 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 11 inclusion and 17 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Hungary, Netherlands, Poland, Romania and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563056, which also lists 1 linked publication.
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 24 Oct 2018.