Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: Salmeterol Xinafoate and Fluticasone Propinate Powder; Drug: Seretide

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: jinping zheng, doctor; Phone Number: 020-83062869; Email: 18928868238@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Jinfeng Feng, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salmeterol Xinafoate and Fluticasone Propinate Powder; Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) 50ug/250ug 1 puff twice a day for 4 weeks	Drug: Salmeterol Xinafoate and Fluticasone Propinate Powder; 50ug/250ug 1 puff twice a day for 4 weeks
Active Comparator: Seretide; 50ug/250ug 1 puff twice a day for 4 weeks	Drug: Seretide; 50ug/250ug 1 puff twice a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): October 31, 2018

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: randomized; double-blind; double-dummy; positive-controlled; parallel-group
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: SMTLTKS-CS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No