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Trial record 45 of 318 for:    FLUTICASONE AND SALMETEROL

A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma

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ClinicalTrials.gov Identifier: NCT03676413
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Respirent Pharmaceuticals Co Ltd.

Brief Summary:
Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals (Test) or ADVAIR DISKUS® 100/50 mcg (Reference) or placebo.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals Drug: ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase III, Randomized, Multicenter, Parallel-group Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Test (T)
Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals
Drug: Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals
new generic product of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder twice daily inhalation throughout the study

Active Comparator: Reference (R)
ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Drug: ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
twice daily inhalation throughout the study
Other Name: ADVAIR DISKUS

Placebo Comparator: Placebo Drug: Placebo
twice daily inhalation throughout the study




Primary Outcome Measures :
  1. Area under the serial FEV1(L)-time curve calculated from time zero to 12 hours (AUC0-12h) on the first day of the treatment after adjustment for baseline (change from baseline) [ Time Frame: 12 hours ]
  2. FEV1(L) measured in the morning prior to the dosing of inhaled medications on the last day of a 4-week treatment (trough FEV1) after adjustment for baseline (change from baseline) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Frequency of rescue medication used during the study period [ Time Frame: 7 weeks ]
  2. Adverse events during the study period [ Time Frame: 7 weeks ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects (≥12 years of age) of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control.
  2. Patients diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP), at least 12 weeks prior to screening.
  3. Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value (for age ≥18 years), or ≥65% and ≤90% predicted normal value (for ages 12 to 17 years) during the screening visit and on the first day of treatment.
  4. Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
  5. ≥12% and 200 mL reversibility of FEV1 within 30 minutes following 400 mcg salbutamol (4 puffs) inhalation (pMDI). This may be demonstrated at the Screening Visit or this test may be repeated on a different day if the patient fails the first attempt anytime in the period leading up to Visit 2 (randomization); If reversibility is not demonstrated up to Visit 2 then patients may be permitted to enter the study with historical evidence of reversibility that was performed within 2 years prior to Visit 1 and patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrolment.
  6. Patients who are able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study, according to investigator's judgement.
  7. Patients who are able to replace current short-acting β agonists (SABAs) with salbutamol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits).
  8. Patients who are able to continue treatment with theophylline or montelukast without a significant adjustment of dosage, formulation, dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each patient visit: 1) montelukast 36 hours 2) short-acting forms of theophylline 12 hours, 3) twice-a-day controlled-release forms of theophylline 24 hours, 4) once-a-day controlled-release forms of theophylline 36 hours.
  9. Patients who are able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits.
  10. Willing to provide voluntary written informed consent and data protection declaration (and in the case of a minor their parent/guardian was able to give) before any clinical trial related procedure is performed.

Exclusion Criteria:

  1. Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year or during the run-in period.
  2. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
  3. Historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
  4. Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
  5. History of hypersensitivity to lactose
  6. Medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines, e.g.: β-blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors.
  7. Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period.
  8. Asthma exacerbations within 6 weeks prior to the screening visit or during the run-in period.
  9. Use of oral or parenteral corticosteroids within 4 weeks prior to Screening visit (Visit 1)
  10. Factors (e.g., infirmity, disability or geographic location) that the investigator felt would likely limit the patient's compliance with the study protocol or scheduled clinic visits.
  11. Female Subjects who are pregnant or breastfeeding.
  12. Women of child-bearing age that are not surgically incapable of pregnancy and are not willing to use an acceptable method of birth control.
  13. Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s).
  14. Unwillingness or inability to comply with the clinical trial procedures;
  15. Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
  16. Who are legally incapacitated
  17. Who are legally detained in an official institute.

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): NCT03676413


Contacts
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Contact: Alexandra Koutarelou, MSc +30-210-6729037 koutarelou@becro.gr
Contact: Chrysoula Doxani, MD, MSc, PhD +30-210-6729037 doxani@becro.gr

Locations
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Greece
BECRO Ltd. Recruiting
Athens, Greece
Contact: Alexandra Koutarelou    6980595837    koutarelou@becro.gr   
Sponsors and Collaborators
Respirent Pharmaceuticals Co Ltd.
Investigators
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Principal Investigator: Athanasios Konstantinidis, Ass.Professor University of Ioannina School of Medicine

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Responsible Party: Respirent Pharmaceuticals Co Ltd.
ClinicalTrials.gov Identifier: NCT03676413     History of Changes
Other Study ID Numbers: BECRO/RESP/BREATH-PD
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Respirent Pharmaceuticals Co Ltd.:
asthma
therapeutic equivalence
bioequivalence
fluticasone propionate
salmeterol
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes
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