search
Back to results

Bioequivalence With Clinical Endpoint Study of 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 (AERO-PD)

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals
ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Placebo
Sponsored by
Respirent Pharmaceuticals Co Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring asthma, therapeutic equivalence, bioequivalence, fluticasone propionate, salmeterol

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Patients diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP), at least 12 weeks prior to screening. 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. 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. ≥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. 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. 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). 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. Patients who are able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits. 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: Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year to the screening or during the run-in period. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. 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. Hypersensitivity to any sympathomimetic drug (e.g., salmeterol/albuterol) or to any inhaled, intranasal, or systemic corticosteroid therapy. History of hypersensitivity to lactose 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. symptoms or signs of 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. Asthma exacerbation (i.e. acute or sub-acute worsening in symptoms and lung function from the patient's usual status) within 6 weeks prior to the screening visit or during the run-in period Use of oral or parenteral corticosteroids within 4 weeks prior to Screening visit (Visit 1) 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. Female Subjects who are pregnant or breastfeeding. Women of child-bearing age that are not surgically incapable of pregnancy and are not willing to use an acceptable method of birth control. Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s). Unwillingness or inability to comply with the clinical trial procedures; Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; Who are legally incapacitated; Who are legally detained in an official institute.

Sites / Locations

  • BECRO Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals

ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK

Placebo

Arm Description

Test (T)

Reference (R)

Placebo

Outcomes

Primary Outcome Measures

FEV1 AUC (0-12h)
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).
Trough FEV1
2. FEV1(L) measured in the morning prior to the dosing of inhaled medications on the last day of a 4-week (28 days) treatment (trough FEV1) after adjustment for baseline (change from baseline).

Secondary Outcome Measures

Full Information

First Posted
December 15, 2022
Last Updated
February 28, 2023
Sponsor
Respirent Pharmaceuticals Co Ltd.
Collaborators
Becro Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05664061
Brief Title
Bioequivalence With Clinical Endpoint Study of 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
Acronym
AERO-PD
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respirent Pharmaceuticals Co Ltd.
Collaborators
Becro Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, therapeutic equivalence, bioequivalence, fluticasone propionate, salmeterol

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
observer-blind
Allocation
Randomized
Enrollment
451 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals
Arm Type
Experimental
Arm Description
Test (T)
Arm Title
ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Arm Type
Active Comparator
Arm Description
Reference (R)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals
Other Intervention Name(s)
Test (T)
Intervention Description
twice daily inhalation throughout the treatment period
Intervention Type
Drug
Intervention Name(s)
ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Other Intervention Name(s)
Refernce (R)
Intervention Description
twice daily inhalation throughout the treatment period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice daily inhalation throughout the treatment period
Primary Outcome Measure Information:
Title
FEV1 AUC (0-12h)
Description
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
Title
Trough FEV1
Description
2. FEV1(L) measured in the morning prior to the dosing of inhaled medications on the last day of a 4-week (28 days) treatment (trough FEV1) after adjustment for baseline (change from baseline).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP), at least 12 weeks prior to screening. 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. 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. ≥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. 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. 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). 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. Patients who are able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits. 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: Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year to the screening or during the run-in period. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. 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. Hypersensitivity to any sympathomimetic drug (e.g., salmeterol/albuterol) or to any inhaled, intranasal, or systemic corticosteroid therapy. History of hypersensitivity to lactose 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. symptoms or signs of 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. Asthma exacerbation (i.e. acute or sub-acute worsening in symptoms and lung function from the patient's usual status) within 6 weeks prior to the screening visit or during the run-in period Use of oral or parenteral corticosteroids within 4 weeks prior to Screening visit (Visit 1) 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. Female Subjects who are pregnant or breastfeeding. Women of child-bearing age that are not surgically incapable of pregnancy and are not willing to use an acceptable method of birth control. Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s). Unwillingness or inability to comply with the clinical trial procedures; Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; Who are legally incapacitated; Who are legally detained in an official institute.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chrysoula Doxani, MD, MSc, PhD
Phone
+30 2410257310
Email
doxani@becro.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Koutarelou, MSc, PhD (Cand.)
Phone
+30 210 6729037
Email
koutarelou@becro.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Kostikas, Professor
Organizational Affiliation
University of Ioannina School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
BECRO Ltd.
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Koutarelou
Phone
6980595837
Email
koutarelou@becro.gr

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence With Clinical Endpoint Study of 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

We'll reach out to this number within 24 hrs