Clinical trial NCT03461627: Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma
Official title: Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Keywords: randomized
double-blind
double-dummy
positive-controlled
parallel-group
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug：Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) Drug：Seretide (50ug/250ug)
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Pregnancy, breast-feeding or planned pregnancy during the study
* Researchers think that do not fit into the group.

Primary outcomes:
measure: Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
timeFrame: 28 days
Secondary outcomes:
measure: Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28
timeFrame: 28 days
measure: FEV1~AUC0-12h
timeFrame: 12 hours
measure: PEF
timeFrame: 28 days
measure: The mean of morning and night Asthma symptom scores
timeFrame: up to 28 days
measure: The mean of peak expiratory flow (PEF)variation of morning and night
timeFrame: up to 28 days
measure: Use of ventolin during the treatment
timeFrame: 28 days
measure: Number of asthma acute exacerbations with subjects
timeFrame: 28 days
measure: Subject self- questionare at visit 4
timeFrame: 28 days
measure: Questionnaire of Asthma control test scores
timeFrame: 28 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
Study officials:
References: