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Trial record 27 of 318 for:    FLUTICASONE AND SALMETEROL

Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma

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ClinicalTrials.gov Identifier: NCT03461627
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Salmeterol Xinafoate and Fluticasone Propinate Powder Drug: Seretide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Drug:Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) Drug:Seretide (50ug/250ug)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28 [ Time Frame: 28 days ]
  2. FEV1~AUC0-12h [ Time Frame: 12 hours ]
    The Forced expiratory volume in 1 second of area under the curve from 0h to 12h on day 1

  3. PEF [ Time Frame: 28 days ]
    The mean of morning and night peak expiratory flow

  4. The mean of morning and night Asthma symptom scores [ Time Frame: up to 28 days ]
    the outcomes are respectively: Day-1~day-7,Day1~day7,Day8~day14,Day15~day21,Day22~day28

  5. The mean of peak expiratory flow (PEF)variation of morning and night [ Time Frame: up to 28 days ]
  6. Use of ventolin during the treatment [ Time Frame: 28 days ]
  7. Number of asthma acute exacerbations with subjects [ Time Frame: 28 days ]
  8. Subject self- questionare at visit 4 [ Time Frame: 28 days ]
    questionare respectively have significant effectiveness , effectiveness ,Invalid , Deterioration

  9. Questionnaire of Asthma control test scores [ Time Frame: 28 days ]
    25 score reprent Partially controlled;20-25 score represent fully controlled;<20 score represent not controlled



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461627


Contacts
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Contact: jinping zheng, doctor 020-83062869 18928868238@163.com

Locations
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China, Guangdong
The First Affiliated Hospital Of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jinfeng Feng, doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03461627     History of Changes
Other Study ID Numbers: SMTLTKS-CS-01
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.:
randomized
double-blind
double-dummy
positive-controlled
parallel-group
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists