AsthmaPhase 3NCT03461627
Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma
A Phase 3 study testing Salmeterol Xinafoate and Fluticasone Propinate Powder and Seretide in people with Asthma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
assess the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) in combination with seretide to patients with Asthma. a randomized, double-blind, double-dummy, positive-controlled, parallel-group trail. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol Xinafoate and Fluticasone Propinate Powder and Seretide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 31 Oct 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with asthma diagnosed according to the Global INitiative for Asthma (GINA) criteria.
- Inadequate asthma control on an inhaled corticosteroids alone at a dose of ≤ 800 μg/day of budesonide, ≤ 1000μg/day of Beclomethasone; ≤ 500 μg/day of fluticasone
- Inadequate asthma control on bronchodilators
- Inadequate asthma control on an ICS (medium and low dose)-LABA combination
- primarily diagnosed with asthma
- Positive bronchodilation test [an increase in of FEV1﹥200 ml and the FEV1 change﹥12% from the baseline] or PEF variation﹥20%
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- Age between 18-70 years
- Patients should participate in the study voluntarily and sign informed consent;
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving study therapy; Male patients can participate if they are surgically sterile or males capable of having children and agree not to attempt pregnancy while receiving study therapy.
Who cannot join
- Allergic to salmeterol, fluticasone propionate or to ventolin.
- Have a current diagnosis of chronic obstructive pulmonary disease (COPD), pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis or other respiratory tract disorders (not including asthma).
- Any respiratory tract infection, sinus infection or eardrum infection within 4 weeks prior to the screening .visit
- History or severe cardiovascular disease or hematopoietic system disease (congestive heart failure, clinically relevant coronary heart disease, apoplexy, clinically relevant cardiac arrhythmias, aortic aneurysm, and uncontrolled hypertension (systolic blood pressure above 160mmHg or diastolic blood pressure above 100 mmHg continuously measured more than twice.))
- Patients treated with leukotriene antagonist, such as zafirlukast, pranlukast, and montelukast.
- Expected medication to improve asthma other than ventolin
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- Subjects who suffer from serious, uncontrolled diseases (including psychological disorders), in researcher's opinion, under great risks.
- Hepatic dysfunction: aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN; renal dysfunction: serum creatinine level of > ULN )
- A history of both HBV infection and HCV infection.
- In Human Immunodeficiency Virus (HIV)-positive status
- Subjects with uncontrolled diabetics or fasting glucose > 10mmol/L
- Use of any β-blocking agent, including eye-drops
- In oral glucocorticoid medication or a history of systemic corticosteroid medication within 30 days of the screening visit
- Subjects who participated in other clinical studies within 2 months
- Subjects who have previously enrolled into this study
- Pregnancy, breast-feeding or planned pregnancy during the study
- Researchers think that do not fit into the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Jinfeng Feng, doctor
About this study
Official title: Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail
assess the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) in combination with seretide to patients with Asthma.
a randomized, double-blind, double-dummy, positive-controlled, parallel-group trail.
- Conditions
- Asthma
- Being tested
- Salmeterol Xinafoate and Fluticasone Propinate Powder, Seretide
- Keywords
- randomized, double-blind, double-dummy, positive-controlled, parallel-group
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol Xinafoate and Fluticasone Propinate PowderDrug
50ug/250ug 1 puff twice a day for 4 weeks
SeretideDrug
50ug/250ug 1 puff twice a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol Xinafoate and Fluticasone Propinate Powder | Experimental | Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) 50ug/250ug 1 puff twice a day for 4 weeks Receives: Drug: Salmeterol Xinafoate and Fluticasone Propinate Powder |
| Seretide | Active comparator | 50ug/250ug 1 puff twice a day for 4 weeks Receives: Drug: Seretide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
Measured: 28 days
Secondary outcomes (9)
Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28
Measured: 28 days
FEV1~AUC0-12h
The Forced expiratory volume in 1 second of area under the curve from 0h to 12h on day 1
Measured: 12 hours
PEF
The mean of morning and night peak expiratory flow
Measured: 28 days
The mean of morning and night Asthma symptom scores
the outcomes are respectively: Day-1~day-7,Day1~day7,Day8~day14,Day15~day21,Day22~day28
Measured: up to 28 days
The mean of peak expiratory flow (PEF)variation of morning and night
Measured: up to 28 days
Use of ventolin during the treatment
Measured: 28 days
Number of asthma acute exacerbations with subjects
Measured: 28 days
Subject self- questionare at visit 4
questionare respectively have significant effectiveness , effectiveness ,Invalid , Deterioration
Measured: 28 days
Questionnaire of Asthma control test scores
25 score reprent Partially controlled；20-25 score represent fully controlled;<20 score represent not controlled
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Apr 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
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.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- Drug：Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) Drug：Seretide (50ug/250ug)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461627
- Sponsor's protocol ID
- SMTLTKS-CS-01
- Status last verified
- Mar 2018
- First submitted
- 28 Dec 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail
- ClinicalTrials.gov ID
- NCT03461627
- Acronym / sponsor ID
- SMTLTKS-CS-01
- Conditions
- Asthma
- Keywords
- randomized, double-blind, double-dummy, positive-controlled, parallel-group
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 12 Mar 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.
assess the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) in combination with seretide to patients with Asthma.
a randomized, double-blind, double-dummy, positive-controlled, parallel-group trail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug：Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) Drug：Seretide (50ug/250ug)
| Arm | Type | Receives |
|---|---|---|
| Salmeterol Xinafoate and Fluticasone Propinate Powder | Experimental | Drug: Salmeterol Xinafoate and Fluticasone Propinate PowderSalmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) 50ug/250ug 1 puff twice a day for 4 weeks |
| Seretide | Active comparator | Drug: Seretide50ug/250ug 1 puff twice a day for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with asthma diagnosed according to the Global INitiative for Asthma (GINA) criteria.
- Positive bronchodilation test [an increase in of FEV1﹥200 ml and the FEV1 change﹥12% from the baseline] or PEF variation﹥20%
- Age between 18-70 years
- Patients should participate in the study voluntarily and sign informed consent;
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving study therapy; Male patients can participate if they are surgically sterile or males capable of having children and agree not to attempt pregnancy while receiving study therapy.
Key exclusion criteria (17 listed)
- Allergic to salmeterol, fluticasone propionate or to ventolin.
- Have a current diagnosis of chronic obstructive pulmonary disease (COPD), pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis or other respiratory tract disorders (not including asthma).
- Any respiratory tract infection, sinus infection or eardrum infection within 4 weeks prior to the screening .visit
- History or severe cardiovascular disease or hematopoietic system disease (congestive heart failure, clinically relevant coronary heart disease, apoplexy, clinically relevant cardiac arrhythmias, aortic aneurysm, and uncontrolled hypertension (systolic blood pressure above 160mmHg or diastolic blood pressure above 100 mmHg continuously measured more than twice.))
- Patients treated with leukotriene antagonist, such as zafirlukast, pranlukast, and montelukast.
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 |
|---|---|---|
| Salmeterol Xinafoate and Fluticasone Propinate Powder50ug/250ug 1 puff twice a day for 4 weeks | Drug | Salmeterol Xinafoate and Fluticasone Propinate Powder |
| Seretide50ug/250ug 1 puff twice a day for 4 weeks | Drug | Seretide |
Primary outcome
Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
Time frame: 28 days
9 secondary outcomes
Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28
Time frame: 28 days
FEV1~AUC0-12h
Time frame: 12 hours
PEF
Time frame: 28 days
The mean of morning and night Asthma symptom scores
Time frame: up to 28 days
The mean of peak expiratory flow (PEF)variation of morning and night
Time frame: up to 28 days
Use of ventolin during the treatment
Time frame: 28 days
Number of asthma acute exacerbations with subjects
Time frame: 28 days
Subject self- questionare at visit 4
Time frame: 28 days
Questionnaire of Asthma control test scores
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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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.
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 Salmeterol Xinafoate and Fluticasone Propinate Powder and Seretide in people with Asthma, run by Chia Tai Tianqing Pharmaceutical Group 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 9 inclusion and 17 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 12 Mar 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 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 jinping zheng, doctor (020-83062869, 18928868238@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28 (time frame: 28 days). 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 12 Mar 2018.