AsthmaPhase 2FLT2503NCT00995800
Study to Assess Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adults With Mild to Moderate Asthma
A Phase 2 study testing Fluticasone propionate / Formoterol fumarate in people with Asthma, run by Mundipharma Research Limited at 1 site in Germany.
Trial summary
This is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate / Formoterol fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects aged between 18 and 55 years inclusive.
- 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 in each treatment period, be non-lactating, and be 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 mild to moderate asthma for ≥ 6 months prior to the screening visit.
- Subject has not received systemic (injectable or oral) corticosteroid medication in the 12 weeks prior to the study screening visit.
- Demonstrate a FEV1 of ≥ 60% predicted FEV1 (Quanjer et al, 1993) at the screening visit, following appropriate withholding of asthma medications (no long-acting β2-agonist or short-acting β2-agonist/anticholinergic use 12 hours and 6 hours prior to screening, respectively).
- Demonstrate AMP challenge PC20FEV1 < 60 mg/mL, following appropriate withholding of asthma medication (no short-acting bronchodilator use 6 hours prior to the AMP challenge test at Visit 2).
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- Non-smoker for at least 12 months prior to study screening. Ex-smokers must have a smoking history equivalent to less than "10 pack years" (i.e. at least 1 pack of 20 cigarettes per day for 10 years or 10 packs per day for 1 year, etc.).
- Demonstrate satisfactory technique in the use of the pMDI.
- 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.
- Hospitalisation or an emergency visit for asthma within 4 weeks prior to the screening visit.
- History of omalizumab use within the past 6 months.
- 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 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.
- 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 evidence or history of alcohol and/or substance abuse within 12 months prior to the screening visit.
- Subjects 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 one week prior to the screening visit.
- History of leukotriene receptor antagonist use, e.g. montelukast, within one week prior to the screening visit.
- Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm and/or pulmonary function.
- Anti-histamines within 2 weeks prior to the screening visit; non-steroidal anti-inflammatory drugs, oral decongestants, inhaled cromolyn sodium, nedocromil sodium within one week prior to the screening visit.
- Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications, rescue medication, or components.
- Use of an investigational drug within 30 days prior to 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
Official title: A Double-blind, Randomised, Incomplete Block, Crossover, Placebo-controlled, Dose-response Study to Assess Bronchial Hyperresponsiveness and Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adult Subjects With Mild to Moderate Asthma
This is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo.
Read the detailed description
The study consists of two 4-week treatment periods, each preceded by a 14-21 wash-out period. Subjects will be randomised to receive two of the three study treatments - FlutiForm® pMDI 50/5 µg, FlutiForm® pMDI 250/10 µg, or placebo (dummy inhaler). During the wash-out periods, subjects will take only salbutamol, if required, as rescue medication.
Subjects will record a daily diary for PEFR, study medication use, rescue medication use, asthma symptom scores, and sleep disturbance due to asthma. Assessments performed at study clinic visits include inhaled adenosine 5'-monophosphate (AMP) challenge test, induced sputum test, exhaled nitric oxide (eNO) test, and spirometry tests. Safety will be assessed by lab tests, vital signs, ECG and adverse events.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate / Formoterol fumarate
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate / Formoterol fumarateDrug
2 dose strength vs. placebo
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate / Formoterol fumarate | Active comparator | Not described Receives: Drug: Fluticasone propionate / Formoterol fumarate |
| Fluticasone propionate / Formoterol fumarate placebo | Placebo comparator | Not described Receives: Drug: Fluticasone propionate / Formoterol fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of each dose strength on bronchial hyperresponsiveness to inhaled adenosine 5'-monophosphate (AMP) challenge.
Secondary outcomes (1)
eNO, % of eosinophils in induced sputum, comp each dose placebo of bronchial hyperresponsive to AMP challenge. Lung func, rescue med use, asthma symps,& exacerbations sleep disturbance, discon due to lack of efficacy & spontaneously reported AEs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 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
- NCT00995800
- Sponsor's protocol ID
- FLT2503
- Other IDs
- 2009-009873-87, 2009
- Acronym
- FLT2503
- Status last verified
- Oct 2018
- First submitted
- 14 Oct 2009
- Last updated
- 24 Oct 2018
- Results posted
- 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
- A Double-blind, Randomised, Incomplete Block, Crossover, Placebo-controlled, Dose-response Study to Assess Bronchial Hyperresponsiveness and Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adult Subjects With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT00995800
- Acronym / sponsor ID
- FLT2503 / FLT2503
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Oct 2009 (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.
This is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo.
Detailed description
The study consists of two 4-week treatment periods, each preceded by a 14-21 wash-out period. Subjects will be randomised to receive two of the three study treatments - FlutiForm® pMDI 50/5 µg, FlutiForm® pMDI 250/10 µg, or placebo (dummy inhaler). During the wash-out periods, subjects will take only salbutamol, if required, as rescue medication.
Subjects will record a daily diary for PEFR, study medication use, rescue medication use, asthma symptom scores, and sleep disturbance due to asthma. Assessments performed at study clinic visits include inhaled adenosine 5'-monophosphate (AMP) challenge test, induced sputum test, exhaled nitric oxide (eNO) test, and spirometry tests. Safety will be assessed by lab tests, vital signs, ECG and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone propionate / Formoterol fumarate | Active comparator | Drug: Fluticasone propionate / Formoterol fumarate |
| Fluticasone propionate / Formoterol fumarate placebo | Placebo comparator | Drug: Fluticasone propionate / Formoterol fumarate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female subjects aged between 18 and 55 years inclusive.
- 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 in each treatment period, be non-lactating, and be 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 mild to moderate asthma for ≥ 6 months prior to the screening visit.
- Subject has not received systemic (injectable or oral) corticosteroid medication in the 12 weeks prior to the study screening visit.
- Demonstrate a FEV1 of ≥ 60% predicted FEV1 (Quanjer et al, 1993) at the screening visit, following appropriate withholding of asthma medications (no long-acting β2-agonist or short-acting β2-agonist/anticholinergic use 12 hours and 6 hours prior to screening, respectively).
Key exclusion criteria (15 listed)
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Hospitalisation or an emergency visit for asthma within 4 weeks prior to the screening visit.
- History of omalizumab use within the past 6 months.
- 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 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.
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 |
|---|---|---|
| Fluticasone propionate / Formoterol fumarate2 dose strength vs. placebo | Drug | Fluticasone propionate / Formoterol fumarate, Fluticasone propionate / Formoterol fumarate placebo |
Primary outcome
Effects of each dose strength on bronchial hyperresponsiveness to inhaled adenosine 5'-monophosphate (AMP) challenge.
1 secondary outcome
eNO, % of eosinophils in induced sputum, comp each dose placebo of bronchial hyperresponsive to AMP challenge. Lung func, rescue med use, asthma symps,& exacerbations sleep disturbance, discon due to lack of efficacy & spontaneously reported AEs.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone propionate / Formoterol fumarate in people with Asthma, run by Mundipharma Research Limited at 1 site in Germany.
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 15 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 Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effects of each dose strength on bronchial hyperresponsiveness to inhaled adenosine 5'-monophosphate (AMP) challenge.. 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.