Asthma BronchialePhase 3NCT00476073
Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
A Phase 3 study testing FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) in people with Asthma Bronchiale, run by Mundipharma Research Limited at 1 site in United Kingdom.
Trial summary
Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)
- How many people
- 228 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2007to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients at least 18 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours 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 sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
- Known history of mild to moderate-severe reversible asthma for > 6 months prior to the screening visit.
- Demonstrate a FEV1 of >40% to <80% for predicted normal values (EGKS normal values, 1983) during the screening phase following appropriate withholding of asthma medications (if applicable).
- No beta agonist use on day of screening.
- No use of 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 pressurized MDI.
- 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.
Who cannot join
- Life-threatening asthma within the past year. This category includes those patients with a history of near-fatal asthma, a hospitalization or an emergency visit for asthma or prior intubation for asthma.
- History of systemic (injectable) 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, 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.
- An 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.
- 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.
- Patients who have taken beta-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
1 site in 1 country.
About this study
Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.
Read the detailed description
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive FLUTIFORM® or Sertetide®. 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® (Formoterol fumarate / Fluticasone propionate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1, (Forced expiratory volume in the 1st second).
Secondary outcomes (1)
Other lung function tests, AQLQ, Safety Assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
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 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Blagden, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476073
- Sponsor's protocol ID
- FLT3501
- Status last verified
- Oct 2018
- First submitted
- 17 May 2007
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Aalbers R, Brusselle G, McIver T, Grothe B, Bodzenta-Lukaszyk A. Onset of bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomized study. Adv Ther. 2012 Nov;29(11):958-69. doi: 10.1007/s12325-012-0058-0. Epub 2012 Oct 17.
PubMed 23081745Bodzenta-Lukaszyk A, Dymek A, McAulay K, Mansikka H. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med. 2011 May 23;11:28. doi: 10.1186/1471-2466-11-28.
PubMed 21605396
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
- Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
- ClinicalTrials.gov ID
- NCT00476073
- Acronym / sponsor ID
- FLT3501
- Conditions
- Asthma Bronchiale
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 May 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.
Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.
Detailed description
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive FLUTIFORM® or Sertetide®. 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients at least 18 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours 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 sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
- Known history of mild to moderate-severe reversible asthma for > 6 months prior to the screening visit.
- Demonstrate a FEV1 of >40% to <80% for predicted normal values (EGKS normal values, 1983) 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 pressurized MDI.
Key exclusion criteria (16 listed)
- Life-threatening asthma within the past year. This category includes those patients with a history of near-fatal asthma, a hospitalization or an emergency visit for asthma or prior intubation for asthma.
- History of systemic (injectable) 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, 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.
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® (Formoterol fumarate / Fluticasone propionate) | Drug | – |
Primary outcome
FEV1, (Forced expiratory volume in the 1st second).
1 secondary outcome
Other lung function tests, AQLQ, Safety Assessments.
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 23081745Aalbers R, Brusselle G, McIver T, Grothe B, Bodzenta-Lukaszyk A. Onset of bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomized study. Adv Ther. 2012 Nov;29(11):958-69. doi: 10.1007/s12325-012-0058-0. Epub 2012 Oct 17.
- Derived from this study: PubMed 21605396Bodzenta-Lukaszyk A, Dymek A, McAulay K, Mansikka H. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med. 2011 May 23;11:28. doi: 10.1186/1471-2466-11-28.
- Related InfoLink provided by the sponsor.
- Results posted on Eu Clinical Trials 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.
Dr Blagden, MD principal investigator
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® (Formoterol fumarate / Fluticasone propionate) in people with Asthma Bronchiale, run by Mundipharma Research Limited at 1 site in United Kingdom.
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 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 United Kingdom. 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?
FEV1, (Forced expiratory volume in the 1st second).. 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 NCT00476073, 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.