Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma

Asthma Clinical Trial

Official title:

Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03461627
• Other study ID #: SMTLTKS-CS-01
• Status: Recruiting
• Phase: Phase 3
• First received: December 28, 2017
• Last updated: March 5, 2018
• Start date: April 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2018
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: jinping zheng, doctor
• Phone: 020-83062869
• Email: 18928868238[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol Xinafoate and Fluticasone Propinate Powder
50ug/250ug 1 puff twice a day for 4 weeks
• Seretide
50ug/250ug 1 puff twice a day for 4 weeks

Locations

Country	Name	City	State
China	The First Affiliated Hospital Of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28		28 days
Secondary	Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28		28 days
Secondary	FEV1~AUC0-12h	The Forced expiratory volume in 1 second of area under the curve from 0h to 12h on day 1	12 hours
Secondary	PEF	The mean of morning and night peak expiratory flow	28 days
Secondary	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	up to 28 days
Secondary	The mean of peak expiratory flow (PEF)variation of morning and night		up to 28 days
Secondary	Use of ventolin during the treatment		28 days
Secondary	Number of asthma acute exacerbations with subjects		28 days
Secondary	Subject self- questionare at visit 4	questionare respectively have significant effectiveness , effectiveness ,Invalid , Deterioration	28 days
Secondary	Questionnaire of Asthma control test scores	25 score reprent Partially controlled;20-25 score represent fully controlled;<20 score represent not controlled	28 days