Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedMarch 12, 2018
March 1, 2018
1.6 years
December 28, 2017
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
28 days
Secondary Outcomes (9)
Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28
28 days
FEV1~AUC0-12h
12 hours
PEF
28 days
The mean of morning and night Asthma symptom scores
up to 28 days
The mean of peak expiratory flow (PEF)variation of morning and night
up to 28 days
- +4 more secondary outcomes
Study Arms (2)
Salmeterol Xinafoate and Fluticasone Propinate Powder
EXPERIMENTALSalmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) 50ug/250ug 1 puff twice a day for 4 weeks
Seretide
ACTIVE COMPARATOR50ug/250ug 1 puff twice a day for 4 weeks
Interventions
50ug/250ug 1 puff twice a day for 4 weeks
Eligibility Criteria
You may qualify if:
- 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%
- 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.
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2017
First Posted
March 12, 2018
Study Start
April 1, 2017
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
March 12, 2018
Record last verified: 2018-03