Asthma, BronchialPhase 3NCT00734318
Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma
A Phase 3 study testing Flutiform 250/10 micrograms, Flutiform 50/5 micrograms and Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms in people with Asthma, Bronchial, run by Mundipharma Research Limited at 1 site in Hungary.
Trial summary
The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Bronchial
- What is being tested?
- Flutiform 250/10 micrograms, Flutiform 50/5 micrograms and Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,667 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2008to Oct 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects at least 18 years old.
- Females less than one year post-menopausal must have a negative 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. 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 sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
- Known history of severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterised by treatment with ICS at a dose of ≥ 500µg fluticasone or equivalent.
- Demonstrated a FEV1 of ≥ 40% to ≤ 80% for predicted normal values (Quanjer et al., 1993) during the Screening Visit (Visit 1) and Randomisation Visit (Visit 3) 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.
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- Inhaled corticosteroids are allowed on day of screening.
- Documented reversibility of ≥ 15% in FEV1 in the screening phase.
- Demonstrated satisfactory technique in the use of the study medication.
- Willing and able to enter information in the electronic 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.
- Subject has used rescue medication for at least 3 days AND had at least one night with sleep disturbance (i.e., sleep disturbance score of ≥ 1) OR at least 3 days with asthma symptoms (i.e., a symptom score of ≥ 1) during the last 7 days of the run-in period.
Who cannot join
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Hospitalisation or an emergency visit for asthma within the 4 weeks before the screening visit.
- Known history of systemic (injectable or oral) corticosteroid medication within 1 month of the Screening Visit.
- Known history of omalizumab use within the past 6 months.
- Current evidence or known 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 subject at risk through study participation, or which would affect the outcome of the study.
- In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
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- Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
- Known Human Immunodeficiency Virus (HIV)-positive status.
- Subject has 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 known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
- Subject has 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 other than those allowed in the protocol that will have an effect on bronchospasm and/or pulmonary function.
- Current evidence or known history of hypersensitivity or idiosyncratic reaction to test medications or components.
- Subject has recieved an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
- Subject is currently participating in a clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.
The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.
Read the detailed description
This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the four treatment groups and will receive either high dose FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
- Conditions
- Asthma, Bronchial
- Being tested
- Flutiform 250/10 micrograms, Flutiform 50/5 micrograms, Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms, Flixotide pMDI 250 micrograms
- Keywords
- Severe asthma, Fluticasone, Formoterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutiform 250/10 microgramsDrug
Flutiform 50/5 microgramsDrug
Flixotide pMDI 250 mcg + foradil pMDI 24 microgramsDrug
Flixotide pMDI 250 microgramsDrug
| Study group | Role | What they receive |
|---|---|---|
| Flutiform 250/10 micrograms | Experimental | Flutiform 250/10 micrograms (2 puffs bd) Receives: Drug: Flutiform 250/10 micrograms |
| Flutiform 50/5 micrograms | Experimental | Flutiform 50/5 micrograms (2 puffs bd) Receives: Drug: Flutiform 50/5 micrograms |
| Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms | Active comparator | Flixotide pMDI 250 mcg (2 puffs bd) + foradil pMDI 24 50/5 mcg (bd) Receives: Drug: Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms |
| Flixotide pMDI 250 micrograms | Active comparator | Flixatide pMDI 250 micrograms (2 puffs bd) Receives: Drug: Flixotide pMDI 250 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of FEV1 (Forced expiratory volume in the first second) values.
8 weeks on treatment
Measured: 8 weeks
Secondary outcomes (1)
Other lung function parameters, asthma symptom scores, sleep disturbance due to asthma, rescue medication use, AQLQ, safety assessments.
8 week treatment period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma, BronchialStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,667 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
- NCT00734318
- Sponsor's protocol ID
- FLT3503
- Other IDs
- 2007-001633-34
- Status last verified
- Oct 2018
- First submitted
- 13 Aug 2008
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dissanayake S, Jain M, Grothe B, McIver T, Papi A. An evaluation of comparative treatment effects with high and low dose fluticasone propionate/formoterol combination in asthma. Pulm Pharmacol Ther. 2015 Dec;35:19-27. doi: 10.1016/j.pupt.2015.10.001. Epub 2015 Nov 10.
PubMed 26474679Bodzenta-Lukaszyk A, Pulka G, Dymek A, Bumbacea D, McIver T, Schwab B, Mansikka H. Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. Respir Med. 2011 May;105(5):674-82. doi: 10.1016/j.rmed.2010.11.011. Epub 2010 Dec 31.
PubMed 21196104
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
- A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.
- ClinicalTrials.gov ID
- NCT00734318
- Acronym / sponsor ID
- FLT3503
- Conditions
- Asthma, Bronchial
- Keywords
- Severe asthma, Fluticasone, Formoterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,667 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Aug 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 study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.
Detailed description
This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the four treatment groups and will receive either high dose FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flutiform 250/10 micrograms | Experimental | Drug: Flutiform 250/10 microgramsFlutiform 250/10 micrograms (2 puffs bd) |
| Flutiform 50/5 micrograms | Experimental | Drug: Flutiform 50/5 microgramsFlutiform 50/5 micrograms (2 puffs bd) |
| Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms | Active comparator | Drug: Flixotide pMDI 250 mcg + foradil pMDI 24 microgramsFlixotide pMDI 250 mcg (2 puffs bd) + foradil pMDI 24 50/5 mcg (bd) |
| Flixotide pMDI 250 micrograms | Active comparator | Drug: Flixotide pMDI 250 microgramsFlixatide pMDI 250 micrograms (2 puffs bd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects at least 18 years old.
- Females less than one year post-menopausal must have a negative 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. 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 sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
- Known history of severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterised by treatment with ICS at a dose of ≥ 500µg fluticasone or equivalent.
- Demonstrated a FEV1 of ≥ 40% to ≤ 80% for predicted normal values (Quanjer et al., 1993) during the Screening Visit (Visit 1) and Randomisation Visit (Visit 3) following appropriate withholding of asthma medications (if applicable).
- Documented reversibility of ≥ 15% in FEV1 in the screening phase.
Key exclusion criteria (16 listed)
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Hospitalisation or an emergency visit for asthma within the 4 weeks before the screening visit.
- Known history of systemic (injectable or oral) corticosteroid medication within 1 month of the Screening Visit.
- Known history of omalizumab use within the past 6 months.
- Current evidence or known 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 subject at risk through study participation, or which would affect the outcome of the 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 |
|---|---|---|
| Flutiform 250/10 micrograms | Drug | Flutiform 250/10 micrograms |
| Flutiform 50/5 micrograms | Drug | Flutiform 50/5 micrograms |
| Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms | Drug | Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms |
| Flixotide pMDI 250 micrograms | Drug | Flixotide pMDI 250 micrograms |
Primary outcome
Comparison of FEV1 (Forced expiratory volume in the first second) values.
Time frame: 8 weeks
8 weeks on treatment
1 secondary outcome
Other lung function parameters, asthma symptom scores, sleep disturbance due to asthma, rescue medication use, AQLQ, safety assessments.
Time frame: 8 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 26474679Dissanayake S, Jain M, Grothe B, McIver T, Papi A. An evaluation of comparative treatment effects with high and low dose fluticasone propionate/formoterol combination in asthma. Pulm Pharmacol Ther. 2015 Dec;35:19-27. doi: 10.1016/j.pupt.2015.10.001. Epub 2015 Nov 10.
- Derived from this study: PubMed 21196104Bodzenta-Lukaszyk A, Pulka G, Dymek A, Bumbacea D, McIver T, Schwab B, Mansikka H. Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. Respir Med. 2011 May;105(5):674-82. doi: 10.1016/j.rmed.2010.11.011. Epub 2010 Dec 31.
- Results available on websiteLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutiform 250/10 micrograms, Flutiform 50/5 micrograms and Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms in people with Asthma, Bronchial, run by Mundipharma Research Limited at 1 site in Hungary.
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 13 inclusion and 16 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 1 site in Hungary. 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 FEV1 (Forced expiratory volume in the first second) values. (time frame: 8 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 NCT00734318, which also lists 2 linked publications.
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.