Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg

NCT03879837 | Completed Phase 3 FDA Drug

• 1 other identifier: TPI-18-03
• Study Type: interventional
• Target: 1,902
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.

Conditions

Asthma

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4.

  4 weeks

Secondary Outcomes (1)

• Superiority over Placebo

  Approximately 4 Weeks

Study Arms (3)

Investigational Test Product

EXPERIMENTAL

Fluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation

Drug: Fluticasone propionate pressurized metered dose inhaler

Reference Listed Drug

ACTIVE COMPARATOR

Flovent HFA pressurized metered dose inhaler, 110 mcg per actuation

Drug: Flovent HFA pressurized metered dose inhaler

Placebo

PLACEBO COMPARATOR

Placebo pressurized metered dose inhaler, no active content

Drug: Placebo pressurized metered dose inhaler

Interventions

Fluticasone propionate pressurized metered dose inhaler DRUG

110 mcg per actuation

Investigational Test Product

Flovent HFA pressurized metered dose inhaler DRUG

110 mcg per actuation

Also known as: Fluticasone propionate pressurized metered dose inhaler

Reference Listed Drug

Placebo pressurized metered dose inhaler DRUG

no active content

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥18 and ≤75 years of age male or female subjects of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
• Body mass index (BMI) ≥18 and ≤45.
• Diagnosis of asthma, as defined by the NAEPP-EPR3 at least 12 months prior to Enrollment at Screening Visit 1a.
• Pre bronchodilator highest forced expiratory volume in 1 second (FEV1) ≥45% and ≤85% of predicted normal value at Screening Visit 1b and on the first day of treatment prior to randomization.
• Reversibility of airway obstruction ≥15% of FEV1 within 30 minutes of 360mcg albuterol inhalation (4 puffs).
• Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to Enrollment at Screening Visit 1a.
• Currently non-smoking, defined as abstinence from all smoking, including marijuana and all tobacco products (i.e., e-cigarettes, cigarettes, cigars, pipe, ortobacco) within the past year, a negative cotinine screening test at Screening Visit 1b, and \<10 pack years of historical use.
• Able to replace current short-acting β agonist (SABA) with study issued albuterol inhaler for use as needed for the duration of the study.
• Able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits.
• Able to withhold all inhaled long acting β agonists (LABA) 24 hours before Screening Visit 1b.
• Able to discontinue current asthma medications (e.g., inhaled corticosteroids\[ICS\], LABA, etc.) during the Run-in period and for remainder of the study.
• Able to comply with study procedures, including correct use of inhaler devices and home peak expiratory flow (PEF) device, and maintaining an electronic diary (eDiary).
• Willingness to give their written informed consent to participate in the study.

You may not qualify if:

• Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations due to asthma within the past year prior to Enrollment, or during the Screening or Run-in period.
• History of significant respiratory disease other than asthma (e.g., chronic obstructive pulmonary disease \[COPD\], interstitial lung disease, chronic bronchitis, emphysema, etc.).
• Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, cardiovascular, endocrine, or other diseases 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 exacerbates during the study.
• Viral or bacterial, upper/lower respiratory tract infection (U/LRTI), or sinus, or middle ear infection within 4 weeks prior to Screening Visit 1b, during the Run-in period, or on the first day of treatment prior to randomization.
• Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
• Hypersensitivity to any of the ingredients of FP pMDI or Flovent HFA.
• Subjects receiving β2 blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to Screening Visit 1b.
• Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to Screening Visit 1b.
• Subjects receiving medications that are strong cytochrome P4503A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 2 weeks prior to Screening Visit 1b.
• Subjects receiving any approved or investigational biological treatment for asthma (e.g., omalizumab, mepolizumab) within 6 months prior to Screening Visit 1b.
• Subjects with clinically relevant abnormal chemistry laboratory findings at Screening Visit 1b as assessed by the Investigator.
• Subjects with clinically significant electrocardiogram (ECG) findings at Screening Visit 1b as assessed by the Investigator and/or cardiologist.
• Subjects who have received any Investigational Product (IP) within 1 month prior to Screening Visit 1b and as described in the Washout Table in Appendix 1.
• Female subjects who are pregnant or breast feeding.
• Evidence of oral candidiasis at Screening or randomization, or history within 1year prior to Screening Visit 1b.

Sponsors & Collaborators

• Actavis Inc.: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Site 1

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: March 25, 2019
• Primary Completion: May 28, 2021
• Study Completion: July 9, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)