AsthmaPhase 3NCT00475813
Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma
A Phase 3 study testing FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) in people with Asthma, run by Mundipharma Research Limited at 6 sites in 6 countries.
Trial summary
Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)
- How many people
- 211 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Mar 2007to Feb 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients between 4-12 years of age. Female patients must be pre-menarche to be eligible.
- Known history of mild to moderate reversible asthma for ≥ 6 months prior to the screening visit.
- Demonstrate a FEV1 of ≥60% to ≤80% of predicted normal values (Zapletal, 1977) 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 during the screening phase.
- Demonstrate satisfactory technique in the use of the pressurized MDI and spacer device.
- Willing and able to enter information in the electronic diary (parental help is acceptable for young children) 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 parental consent obtained, and where possible informed assent from the patient.
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 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, 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.
- Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
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- Known Human Immunodeficiency Virus (HIV)-positive status.
- 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 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
Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.
Read the detailed description
This is a study involving a 12 week treatment phase followed by a 6 month extension phase. During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase all subjects receive FLUTIFORM®. 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
- Being tested
- FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)
- Keywords
- Paediatric subjects with asthma
- Medical subject headings
- Asthma
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, recorded at visits to investigator at 2 wks, 6wks & 12 wks.
Secondary outcomes (1)
Lung function tests, peak expiratory flow rate, asthma symptoms & exacerbations, adverse events, sleep disturbance, rescue medication use, plasma cortisol (extension only).
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 startMar 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 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
- NCT00475813
- Sponsor's protocol ID
- FLT3502
- Other IDs
- 2006-005928-16
- Status last verified
- Oct 2018
- First submitted
- 18 May 2007
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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
- Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00475813
- Acronym / sponsor ID
- FLT3502
- Conditions
- Asthma
- Keywords
- Paediatric subjects with asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 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.
Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.
Detailed description
This is a study involving a 12 week treatment phase followed by a 6 month extension phase. During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase all subjects receive FLUTIFORM®. 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
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Male or female patients between 4-12 years of age. Female patients must be pre-menarche to be eligible.
- Known history of mild to moderate reversible asthma for ≥ 6 months prior to the screening visit.
- Demonstrate a FEV1 of ≥60% to ≤80% of predicted normal values (Zapletal, 1977) during the screening phase following appropriate withholding of asthma medications (if applicable).
- Documented reversibility of ≥ 15% in FEV1 during the screening phase.
- Demonstrate satisfactory technique in the use of the pressurized MDI and spacer device.
Key exclusion criteria (14 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 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, 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.
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, recorded at visits to investigator at 2 wks, 6wks & 12 wks.
1 secondary outcome
Lung function tests, peak expiratory flow rate, asthma symptoms & exacerbations, adverse events, sleep disturbance, rescue medication use, plasma cortisol (extension only).
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.
- 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.
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® (Formoterol fumarate / Fluticasone propionate) in people with Asthma, 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 14 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 Czechia, France, Germany, Hungary, Poland 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?
FEV1, recorded at visits to investigator at 2 wks, 6wks & 12 wks.. 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 24 Oct 2018.