AsthmaPhase 3NCT03387241
Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years
A Phase 3 study testing Fluticasone/ Formoterol and fluticasone/ salmeterol in people with Asthma, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FLUTIFORM® pMDI (2 puffs bid) vs Seretide® pMDI (2 puffs bid) in subjects aged ≥12 years with moderate to severe persistent, reversible asthma. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone/ Formoterol and fluticasone/ salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2017to 30 Mar 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects at least aged ≥12 years old.
- Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterized by inadequate asthma control on treatment with an ICS alone OR controlled asthma on treatment with an ICS-LABA combination.
- Demonstrated a pre-dose FEV1 of ≥ 40% to ≤ 80% for predicted normal values during the Screening Visit (Visit 1) following appropriate withholding of asthma medications (if applicable).
- No LABA use within 12 hours and/or no SABA use within 6 hours of the PFT.
- No SAMA (e.g., ipratropium) use within 8 hours and/or no LAMA (e.g., tiotropium) use within 72 hours of the PFT.
- No use of inhaled ICS-LABA combination asthma therapy within 12 hours of the PFT.
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- Inhaled corticosteroids are allowed on the day of screening.
- Oral Aminophylline should be withheld for at least 24 hours prior to the PFT.
- Documented FEV1 reversibility of ≥ 12% (plus ≥ 200ml if the subject is older than 18 years old) within last 12 months which could be accepted by the investigator, or during the screening phase or at Visit 2.
- Demonstrated satisfactory technique in the use of the study medication.
- Females of child bearing potential or less than one year post-menopausal must have a negative serum pregnancy test recorded at the screening visit and a negative urine pregnancy test result 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.
- 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, for <18 years old subjects, both parental consent and subjects assent are needed.
- Besides The Inclusion/Exclusion Criteria Checking, Additional Randomisation Criteria Required Following Run-In Period:
- Demonstrated a pre-dose FEV1 of ≥ 40% to ≤ 80% for predicted normal values at Randomisation Visit (Visit 3) following appropriate withholding of asthma medications (if applicable).
- ACQ score at Visit 3 ≥ 1.0.
- Subjects with a good compliance with treatment or patient dairy. The definition of good compliance is that the completeness of diary during the last 14 days of the run-in period is at least 80%. The compliance on diary completeness will be assessed from the aspects below and agreed by the investigator and study Medical Monitor:
- Diary info has been filled out on ≥80% of the days during the last 14 days before randomization (e.g., at least 11 days with diary filled completed out of the last 14 days prior to randomization).
- 80% main items including the study endpoints related ones have been filled out within the last 14 days prior to randomization.
- No other significant incompliance judged by the investigator that indicates the potential future incompliance for critical data collection during the study treatment period.
Who cannot join
- The adolescent subjects (age ≥ 12 years to <18 years) who are on ICS alone at a dose >250μg bid fluticasone or equivalent OR ICS-LABA combination at a dose of Seretide > 250/50 μg bid or equivalent.
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Chest X-ray at the Investigator's discretion from clinical perspective that reveals evidence of clinically significant abnormalities not believed to be due to asthma.
- Hospitalization or an emergency visit for asthma within the 4 weeks before the screening visit or during the screening visit.
- Use of systemic (injectable or oral) corticosteroid medication within 1 month of the Screening Visit.
- Omalizumab use within the past 6 months prior to the Screening Visit.
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- 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.
- Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
- 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.) or significant history of exposure to biomass fuel combustion which may be considered a plausible contributory cause to the subject's obstructive lung disease.
- 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 contraindications to the investigational products or components, including the history of paradoxical bronchospasm after inhalation therapy as immediate increase in wheezing and shortness of breath.
- Subject has received an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
- Subject is currently participating in another clinical study or has already been randomized in this study.
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding, cooperation or any factors might block patients from protocol defined visits and may impact the patient diary completion at the Investigator's discretion.
Trial locations and contacts
1 site in 1 country.
Dan Zhu contact
China1 site, 1 recruiting
- Recruiting
China-Japanese Friendship Hospital
Beijing, Beijing Municipality
Jiangtao Lin, Prof., jiangtao_l@263.net
About this study
Official title: A Double Blind, Double Dummy, Randomised, Multicentre, Two Arm Parallel Group Study to Assess the Efficacy and Safety of FLUTIFORM® pMDI (2 Puffs Bid) vs Seretide® pMDI (2 Puffs Bid) in Subjects Aged ≥12 Years With Moderate to Severe Persistent, Reversible Asthma
A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FLUTIFORM® pMDI (2 puffs bid) vs Seretide® pMDI (2 puffs bid) in subjects aged ≥12 years with moderate to severe persistent, reversible asthma.
Read the detailed description
The primary objective is to show non-inferiority in the efficacy of FLUTIFORM ® pMDI (2 puffs bid) versus Seretide® pMDI (2 puffs bid) based on the change from the pre-dose forced expiratory volume in the first second (FEV1) at baseline to 2 hours post-dose FEV1 at Week 12.
- Conditions
- Asthma
- Being tested
- Fluticasone/ Formoterol, fluticasone/ salmeterol
- Keywords
- moderate, severe, persistent, reversible, Seretide, Flutiform
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone/ FormoterolDrug
Also called FLUTIFORM® pMDI (2 puffs bid)
See above
fluticasone/ salmeterolDrug
Also called Seretide® pMDI (2 puffs bid)
See above
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone/ Formoterol (Flutiform) | Experimental | Dosage Form:2 puffs
Unit Strength:
Low dose: 50/5 µg Mid dose: 125/5 µg High dose 250/10 µg Dosing Frequency:BID Mode of Administration:Inhaled Receives: Drug: Fluticasone/ Formoterol |
| Fluticasone/ salmeterol (Seretide) | Active comparator | Dosage Form:2 puffs
Unit Strength:
Low dose: 50/25 µg Mid dose: 125/25 µg High dose 250/25 µg Dosing Frequency:BID Mode of Administration:Inhaled Receives: Drug: fluticasone/ salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12.
The change in pre-dose FEV1 from baseline to the 2-hours post dose FEV1 values at Week 12 will be analysed using a repeated measures ANCOVA model with fixed terms for treatment, baseline pre-dose FEV1, asthma severity, dose group, week and treatment by week interaction, and centre as a random effect. The statistical model will be used to calculate the treatment difference for the change in pre-dose FEV1 to 2 hours post-dose FEV1 at Week 12 (FLUTIFORM® - Seretide), corresponding 95% CI and p-value from the one-sided test for non-inferiority.
Measured: 12 weeks
Secondary outcomes (16)
The key secondary efficacy endpoint is the change in pre dose FEV1 from baseline to pre dose FEV1 at Week 12.
The change in pre dose FEV1 from baseline to the pre dose FEV1 values at Week 12 will be analysed using a repeated measures ANCOVA model with fixed terms for treatment, baseline pre dose FEV1, asthma severity, dose group, week and treatment by week interaction, and centre as a random effect. The statistical model will be used to calculate the treatment difference for the change in pre-dose FEV1 from baseline at Week 12 (FLUTIFORM® - Seretide), corresponding 95% CI and p-value from the test for non-inferiority. Non-inferiority will be concluded if the lower limit of the 95% CI is greater than or equal to -200ml.
Measured: 12 weeks
The change in pre dose FEV1 from baseline to 2-hours post dose FEV1 at Week 2 and Week 6
The change in pre-dose FEV1 from baseline to the 2-hours post dose FEV1 values at baseline (post-IMP), Week 2 and Week 6 will be analysed using a repeated measures ANCOVA model with fixed terms for treatment, baseline pre-dose FEV1, asthma severity, dose group, week and treatment by week interaction, and centre as a random effect. The statistical model will be used to calculate the treatment difference for the change in pre-dose FEV1 to 2 hours post-dose FEV1 at Week 2 and Week 6 (FLUTIFORM® - Seretide), corresponding 95% CI and p-value from the one-sided test for non-inferiority.
Measured: 2 weeks,6 weeks
The change in pre dose FEV1 from baseline to pre dose FEV1 at Week 2 and Week 6
The change in pre dose FEV1 from baseline to the pre dose FEV1 values at Week 2 and Week 6 will be analysed using a repeated measures ANCOVA model with fixed terms for treatment, baseline pre dose FEV1, asthma severity, dose group, week and treatment by week interaction, and centre as a random effect. The statistical model will be used to calculate the treatment difference for the change in pre-dose FEV1 from baseline at Week 2 and Week 6 (FLUTIFORM® - Seretide), corresponding 95% CI and p-value from the test for non-inferiority. Non-inferiority will be concluded if the lower limit of the 95% CI is greater than or equal to -200ml.
Measured: 2 weeks,6 weeks
The number and percentage of subjects who discontinue due to lack of efficacy will be summarised for each treatment group
The Odds Ratio for Seretide versus Flutiform, corresponding 95% CI and p-value will be presented
Measured: up to 12 weeks
Change from baseline in daily morning and evening peak expiratory flow rate (PEFR) at Week 2, 6 and 12 and on average during the 12 week treatment period.
Morning and evening PEFR data obtained from the last 7 days prior to each visit will further be averaged for each subject to get a mean value which corresponds to the respective scheduled visit. The calculated morning and evening PEFR values at baseline, Week 2, Week 6 and Week 12 and change from baseline at each time point will be summarized by treatment group as continuous data.
Measured: 2 weeks, 6 weeks, 12 weeks
Change from baseline in other lung function parameters (PEFR) at Week 2, Week 6 and Week 12.
The other in-clinic lung function (PEFR) values assessed at each time-point (baseline, Week 2, Week 6, Week 12 and end of study), and the change from baseline to each post-baseline time-point will be summarised by treatment group as continuous data.
These lung function values will be analysed using the same methodology applied to the primary and key secondary endpoint, for change in pre- and 2 hour post-dose lung function, respectively.
Measured: 2 weeks, 6 weeks, 12 weeks
Change from baseline in other lung function parameters (FVC) at Week 2, Week 6 and Week 12.
The other in-clinic lung function (FVC) values assessed at each time-point (baseline, Week 2, Week 6, Week 12 and end of study), and the change from baseline to each post-baseline time-point will be summarised by treatment group as continuous data.
These lung function values will be analysed using the same methodology applied to the primary and key secondary endpoint, for change in pre- and 2 hour post-dose lung function, respectively.
Measured: 2 weeks, 6 weeks, 12 weeks
Change from baseline in other lung function parameters (FEF25-75) at Week 2, Week 6 and Week 12.
The other in-clinic lung function (FEF25-75) values assessed at each time-point (baseline, Week 2, Week 6, Week 12 and end of study), and the change from baseline to each post-baseline time-point will be summarised by treatment group as continuous data.
These lung function values will be analysed using the same methodology applied to the primary and key secondary endpoint, for change in pre- and 2 hour post-dose lung function, respectively.
Measured: 2 weeks, 6 weeks, 12 weeks
Change in asthma symptom scores from baseline at Week 2, 6, and 12 and on average during the 12 week treatment period.
Asthma symptom scores obtained from the last 7 days prior to each visit will further be averaged for each subject to get a mean value which corresponds to the respective scheduled visit. The calculated asthma symptom score values at baseline, Week 2, Week 6 and Week 12 and change from baseline at each time point will be summarized by treatment group as continuous data.
Measured: 2 weeks, 6 weeks, 12 weeks
Change in sleep disturbance scores from baseline at Week 2, 6, and 12 and on average during the 12 week treatment period
Sleep disturbance scores obtained from the last 7 days prior to each visit will further be averaged for each subject to get a mean value which corresponds to the respective scheduled visit. The calculated sleep disturbance score values at baseline, Week 2, Week 6 and Week 12 and change from baseline at each time point will be summarized by treatment group as continuous data.
Measured: 2 weeks, 6 weeks, 12 weeks
Change in percentage of asthma control days from baseline at Week 2, 6, and 12 and on average during the 12 week treatment period.
Asthma control days will be defined as an asthma symptom score of 0 (no symptoms), a sleep disturbance score of 0 (slept through the night) and no inhalations of rescue medication. Asthma control scores obtained from the last 7 days prior to each visit will further be averaged for each subject to get a mean value which corresponds to the respective scheduled visit. The calculated percentage of asthma control days at baseline, Week 2, Week 6 and Week 12 and change from baseline at each time point will be summarized by treatment group as continuous data.
Measured: 2 weeks, 6 weeks, 12 weeks
Proportion of patients achieving well controlled asthma [ ACQ(Asthma Control Questionnaire) score ≤ 0.75 units] at Week 12.
The number and percentage of subjects achieving well controlled asthma (ACQ score ≤ 0.75 units) at Week 12 will be summarised by treatment group. The data will be analysed using logistic regression with fixed terms for treatment, baseline ACQ score, asthma severity, dose group and centre as a random effect. The Odds Ratio for Seretide versus Flutiform, corresponding 95% CI and p-value will be presented. Subjects with missing data at Week 12 will be considered as subjects not achieving well controlled asthma for the purpose of analysis.
Measured: 12 weeks
Change in asthma control questionnaire (ACQ) score from baseline to Week 2 and Week 12.
The ACQ questionnaire at each time-point (baseline, Week 2, Week 12 and end of study) and the change from baseline to each post-baseline time-point will be summarised by treatment group as continuous data.
Measured: 2 weeks,12 weeks
Proportion of subjects achieving a decrease from baseline to Week 12 in ACQ(Asthma Control Questionnaire) score ≥ 0.5 units.
The number and percentage of subjects achieving a decrease from baseline to week 12 of ≥ 0.5 ACQ units will be summarised by treatment group. The data will be analysed using logistic regression with fixed terms for treatment, baseline ACQ score, asthma severity, dose group and centre as a random effect. The Odds Ratio for Seretide versus Flutiform, corresponding 95% CI and p-value will be presented. Subjects with missing data at Week 12 will be considered as subjects without a decrease of ≥ 0.5 ACQ units for the purpose of analysis.
Measured: 12 weeks
Change in average number of occasions of daily rescue medication (salbutamol) use from baseline during the 12 week treatment period.(salbutamol) will as assessed based on subject diaries records
The mean number of occasions per day will be calculated from the subject diaries for the 12 week treatment and baseline period. For the baseline value, data from the last 7 days prior to first IMP intake will be used.
The mean number of occasions per day during baseline and the 12 week treatment period and the change from baseline during the treatment period will be summarized treatment group as continuous data.
Measured: 12 weeks
Asthma exacerbations (incidence of subjects with at least one treatment emergent asthma exacerbation and time to first treatment emergent asthma exacerbation).
Asthma exacerbations will be analyzed using two different data sources:
- Based on exacerbations documented in the CRF by the investigator
- Programmatically derived from the diary data and relevant CRF pages Analyses on exacerbations documented by the investigator on the CRF will be considered the main analyses. Analyses on exacerbations obtained programmatically from the diary data will be considered as supportive analyses.
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 posted2 Jan 2018
- Study start2 Jun 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Yu, Study director, victoria.yu@mundipharma.com.cn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387241
- Sponsor's protocol ID
- FLT13-CN-301
- Status last verified
- Apr 2019
- First submitted
- 10 Nov 2017
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Double Dummy, Randomised, Multicentre, Two Arm Parallel Group Study to Assess the Efficacy and Safety of FLUTIFORM® pMDI (2 Puffs Bid) vs Seretide® pMDI (2 Puffs Bid) in Subjects Aged ≥12 Years With Moderate to Severe Persistent, Reversible Asthma
- ClinicalTrials.gov ID
- NCT03387241
- Acronym / sponsor ID
- FLT13-CN-301
- Conditions
- Asthma
- Keywords
- moderate, severe, persistent, reversible, Seretide, Flutiform
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 2 Jan 2018 (actual)
- 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.
A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FLUTIFORM® pMDI (2 puffs bid) vs Seretide® pMDI (2 puffs bid) in subjects aged ≥12 years with moderate to severe persistent, reversible asthma.
Detailed description
The primary objective is to show non-inferiority in the efficacy of FLUTIFORM ® pMDI (2 puffs bid) versus Seretide® pMDI (2 puffs bid) based on the change from the pre-dose forced expiratory volume in the first second (FEV1) at baseline to 2 hours post-dose FEV1 at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone/ Formoterol (Flutiform) | Experimental | Drug: Fluticasone/ FormoterolDosage Form:2 puffs Unit Strength: Low dose: 50/5 µg Mid dose: 125/5 µg High dose 250/10 µg Dosing Frequency:BID Mode of Administration:Inhaled |
| Fluticasone/ salmeterol (Seretide) | Active comparator | Drug: fluticasone/ salmeterolDosage Form:2 puffs Unit Strength: Low dose: 50/25 µg Mid dose: 125/25 µg High dose 250/25 µg Dosing Frequency:BID Mode of Administration:Inhaled |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female subjects at least aged ≥12 years old.
- Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterized by inadequate asthma control on treatment with an ICS alone OR controlled asthma on treatment with an ICS-LABA combination.
- Demonstrated a pre-dose FEV1 of ≥ 40% to ≤ 80% for predicted normal values during the Screening Visit (Visit 1) following appropriate withholding of asthma medications (if applicable).
- Documented FEV1 reversibility of ≥ 12% (plus ≥ 200ml if the subject is older than 18 years old) within last 12 months which could be accepted by the investigator, or during the screening phase or at Visit 2.
- Demonstrated satisfactory technique in the use of the study medication.
Key exclusion criteria (18 listed)
- The adolescent subjects (age ≥ 12 years to <18 years) who are on ICS alone at a dose >250μg bid fluticasone or equivalent OR ICS-LABA combination at a dose of Seretide > 250/50 μg bid or equivalent.
- Near fatal or life-threatening (including intubation) asthma within the past year.
- Chest X-ray at the Investigator's discretion from clinical perspective that reveals evidence of clinically significant abnormalities not believed to be due to asthma.
- Hospitalization or an emergency visit for asthma within the 4 weeks before the screening visit or during the screening visit.
- Use of systemic (injectable or oral) corticosteroid medication within 1 month of 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/ FormoterolAlso: FLUTIFORM® pMDI (2 puffs bid)See above | Drug | Fluticasone/ Formoterol (Flutiform) |
| fluticasone/ salmeterolAlso: Seretide® pMDI (2 puffs bid)See above | Drug | Fluticasone/ salmeterol (Seretide) |
Primary outcome
The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12.
Time frame: 12 weeks
The change in pre-dose FEV1 from baseline to the 2-hours post dose FEV1 values at Week 12 will be analysed using a repeated measures ANCOVA model with fixed terms for treatment, baseline pre-dose FEV1, asthma severity, dose group, week and treatment by week interaction, and centre as a random effect. The statistical model will be used to calculate the treatment difference for the change in pre-dose FEV1 to 2 hours post-dose FEV1 at Week 12 (FLUTIFORM® - Seretide), corresponding 95% CI and p-value from the one-sided test for non-inferiority.
16 secondary outcomes
The key secondary efficacy endpoint is the change in pre dose FEV1 from baseline to pre dose FEV1 at Week 12.
Time frame: 12 weeks
The change in pre dose FEV1 from baseline to 2-hours post dose FEV1 at Week 2 and Week 6
Time frame: 2 weeks,6 weeks
The change in pre dose FEV1 from baseline to pre dose FEV1 at Week 2 and Week 6
Time frame: 2 weeks,6 weeks
The number and percentage of subjects who discontinue due to lack of efficacy will be summarised for each treatment group
Time frame: up to 12 weeks
Change from baseline in daily morning and evening peak expiratory flow rate (PEFR) at Week 2, 6 and 12 and on average during the 12 week treatment period.
Time frame: 2 weeks, 6 weeks, 12 weeks
Change from baseline in other lung function parameters (PEFR) at Week 2, Week 6 and Week 12.
Time frame: 2 weeks, 6 weeks, 12 weeks
Change from baseline in other lung function parameters (FVC) at Week 2, Week 6 and Week 12.
Time frame: 2 weeks, 6 weeks, 12 weeks
Change from baseline in other lung function parameters (FEF25-75) at Week 2, Week 6 and Week 12.
Time frame: 2 weeks, 6 weeks, 12 weeks
Change in asthma symptom scores from baseline at Week 2, 6, and 12 and on average during the 12 week treatment period.
Time frame: 2 weeks, 6 weeks, 12 weeks
Change in sleep disturbance scores from baseline at Week 2, 6, and 12 and on average during the 12 week treatment period
Time frame: 2 weeks, 6 weeks, 12 weeks
Change in percentage of asthma control days from baseline at Week 2, 6, and 12 and on average during the 12 week treatment period.
Time frame: 2 weeks, 6 weeks, 12 weeks
Proportion of patients achieving well controlled asthma [ ACQ(Asthma Control Questionnaire) score ≤ 0.75 units] at Week 12.
Time frame: 12 weeks
Change in asthma control questionnaire (ACQ) score from baseline to Week 2 and Week 12.
Time frame: 2 weeks,12 weeks
Proportion of subjects achieving a decrease from baseline to Week 12 in ACQ(Asthma Control Questionnaire) score ≥ 0.5 units.
Time frame: 12 weeks
Change in average number of occasions of daily rescue medication (salbutamol) use from baseline during the 12 week treatment period.(salbutamol) will as assessed based on subject diaries records
Time frame: 12 weeks
Asthma exacerbations (incidence of subjects with at least one treatment emergent asthma exacerbation and time to first treatment emergent asthma exacerbation).
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Individual participant dataSharing planned: No
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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.
Dan Zhu contact
Victoria Yu study director
victoria.yu@mundipharma.com.cn
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 Fluticasone/ Formoterol and fluticasone/ salmeterol in people with Asthma, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.
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 21 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 29 Apr 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Li (8610 65636891, ling.li@mundipharma.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12. (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 NCT03387241, 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 29 Apr 2019.