Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg)

NCT03535870 | Completed

• 1 other identifier: FLSA-P100/50-PVCL-2
• Study Type: interventional
• Target: 1,556
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• FEV1-time curve (day 1)

  Baseline-adjusted area under the serial FEV1-time curve calculated from time 0 (zero) to 12 hours on the first day of the Treatment Period

  24 hours

• FEV1-time curve (day 28)

  Baseline-adjusted, pre-dose FEV1 on the last day of the Treatment Period

  24 hours

Study Arms (3)

Fluticasone propionate/salmeterol

EXPERIMENTAL

fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) twice a day by inhalation throughout the study

Drug: Fluticasone propionate/salmeterol

Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder

ACTIVE COMPARATOR

Advair Diskus (fluticasone propionate and salmeterol xinafoate) twice a day by inhalation throughout the study

Drug: Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder

Placebo

PLACEBO COMPARATOR

placebo inhaled powder twice a day by inhalation throughout the study

Drug: Placebo

Interventions

Fluticasone propionate/salmeterol DRUG

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the LOMI inhaler device

Fluticasone propionate/salmeterol

Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder DRUG

Advair (Fixed dose combination of fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)

Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder

Placebo DRUG

placebo dry powder administered via the LOMI inhaler device

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects must be 12 years of age or older.
• Females must not be of childbearing potential or if of childbearing potential, must commit to consistent use of a form of birth control which is medically effective, in the judgment of the investigator.
• Be able to provide written informed consent or, in the case of adolescents, informed assent in addition to an informed consent form (ICF) signed by the adolescent's parent(s) or legal guardian(s).
• Be current non-smokers and also may not have used tobacco products (e.g., cigarettes, e-cigarettes, cigars, pipe tobacco) within the year prior to Visit 1, and have 10 years or less (10 pack-years for cigarettes) of historical use.
• Have persistent asthma, as defined by the National Asthma Education and Prevention Program, for at least 12 weeks before Visit 1.
• FEV1 at Visit 1 (screening) and Visit 2 (randomization) of: ≥40% and ≤85% predicted normal value (for age ≥18 years), or ≥65% and ≤85% predicted normal value (for ages 12 to 17 years)
• Demonstrate ≥15% reversibility of FEV1 between 10 and 30 minutes following 360 μg of albuterol inhalation. This may be demonstrated at the Screening Visit or anytime in the period leading up to Visit 2 (randomization).
• Be able to discontinue controller asthma medication (including LTM, inhaled corticosteroids \[ICS\] and long-acting β-agonists (LABAs\]) during the Run-in Period and Treatment Period.
• Be able to replace current short-acting β-agonists (SABAs) with the study-supplied albuterol (or equivalent) rescue medication inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for a least 6 hours before lung function assessments during study visits).
• Must not have been treated (for any reason) with oral or parenteral corticosteroids for at least 1 month before Visit 1 and must not have used oral SABAs (not inhaled) for at least 12 hours before Visit 1 and for the remainder of the study. Use of oral/parenteral corticosteroids and oral SABAs is prohibited after Visit 1.
• Subjects may continue using short-acting forms of theophylline (withheld at least 12 hours before study visits), twice daily controlled-release forms of theophylline (withheld at least 24 hours before study visits), and once daily controlled-release forms of theophylline (withheld at least 36 hours before study visits). Subjects must be judged by the investigator as able to withhold these medications for the specified minimum time intervals before each site visit.
• Be able to answer questions regarding asthma status and be able to document device usage and asthma status on a twice daily basis.
• Demonstrate proper use of MDI and dry-powder inhaler devices.

You may not qualify if:

• Have a FEV1 reversibility of \<15% at Visit 1.
• Are unable to discontinue ICS, LABA, or LTM.
• Have a history of life-threatening asthma, defined as an asthma episode (at any time in the past) associated with any of the following: respiratory arrest or intubation, hypercapnia, hypoxic seizures, or syncopal episode.
• Have a hospitalization within the year prior to Screening due to an asthma exacerbation.
• Have exercise-induced asthma as the only asthma-related diagnosis that does not require daily asthma control medicine.
• Have evidence or history of congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
• Have evidence or history of any disease (hematologic, hepatic, neurologic, psychiatric, renal, or other) that in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
• Have any other relevant pulmonary disease except for asthma, including but not limited to chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, active pulmonary tuberculosis, pulmonary carcinoma, pulmonary fibrosis, or pulmonary hypertension.
• Have obstructive sleep apnea severe enough to warrant a prescription for biphasic or continuous positive-airway pressure therapy (BiPAP or CPAP), regardless of subject compliance with this therapy.
• Taking any of the following medications:
• Oral or parenteral beta blockers (excluding eye drops)
• Strong cytochrome P450 3A4 inhibitors
• Anti-IgE therapy, Xolair (omalizumab)
• Monoamine oxidase (MAO) Inhibitors
• Monoclonal antibodies/biologic agents which may affect the course of asthma (such as mepolizumab, reslizumab, lebrizumab, and others)

Sponsors & Collaborators

• West-Ward Pharmaceutical: lead

Study Sites (1)

West-Ward Research Site #1

Las Vegas, Nevada, 89119, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 24, 2018
• Study Start: April 26, 2018
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)