ClinicalTrials.gg
CompletedNCT03879837Updated Sep 1, 2021

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

A Phase 3 interventional study of Fluticasone propionate pressurized metered dose inhaler and Flovent HFA pressurized metered dose inhaler in Asthma, sponsored by Actavis Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-01.

Sponsored by Actavis Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2021, 5 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
1,902
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Bioequivalence
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's enrollment of 1,902 is above the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Actavis Inc. is the lead sponsor of 95 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

First submitted after Actavis Inc. became part of Teva Pharmaceutical Industries, Ltd..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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 .
  2. (BMI) ≥18 and ≤45.
  3. Diagnosis of asthma, as defined by the NAEPP-EPR3 at least 12 months prior to Enrollment at Screening Visit 1a.
  4. Pre bronchodilator highest (FEV1) ≥45% and ≤85% of predicted normal value at Screening Visit 1b and on the first day of treatment prior to randomization.
  5. Reversibility of airway obstruction ≥15% of FEV1 within 30 minutes of 360mcg albuterol inhalation (4 puffs).
  6. Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to Enrollment at Screening Visit 1a.
  7. 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.
  8. Able to replace current short-acting β agonist (SABA) with study issued albuterol inhaler for use as needed for the duration of the study.
  9. Able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits.
  10. Able to withhold all inhaled long acting β agonists (LABA) 24 hours before Screening Visit 1b.
  11. Able to discontinue current asthma medications (e.g., inhaled [ICS], LABA, etc.) during the Run-in period and for remainder of the study.
  12. 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).
  13. Willingness to give their written to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. History of significant respiratory disease other than asthma (e.g., [COPD], interstitial lung disease, chronic bronchitis, emphysema, etc.).
  3. Evidence or history of 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.
  4. 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.
  5. to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic therapy.
  6. Hypersensitivity to any of the ingredients of FP pMDI or Flovent HFA.
  7. Subjects receiving β2 blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to Screening Visit 1b.
  8. Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to Screening Visit 1b.
  9. Subjects receiving medications that are strong cytochrome P4503A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 2 weeks prior to Screening Visit 1b.
  10. Subjects receiving any approved or biological treatment for asthma (e.g., omalizumab, mepolizumab) within 6 months prior to Screening Visit 1b.
  11. Subjects with clinically relevant abnormal chemistry laboratory findings at Screening Visit 1b as assessed by the Investigator.
  12. Subjects with clinically significant (ECG) findings at Screening Visit 1b as assessed by the Investigator and/or cardiologist.
  13. Subjects who have received any Investigational Product (IP) within 1 month prior to Screening Visit 1b and as described in the Table in Appendix 1.
  14. Female subjects who are pregnant or breast feeding.
  15. Evidence of oral candidiasis at Screening or randomization, or history within 1year prior to Screening Visit 1b.
  16. Evidence or history of tuberculosis, hypercorticism, or adrenal suppression.
  17. Evidence or history within the 6 months prior to Screening Visit 1b of clinically relevant eye problems such as cataracts. Any previous diagnosis or treatment for ocular hypertension or glaucoma is exclusionary.
  18. Subjects with hyperbilirubinemia (defined as [AST] or alanine aminotransferase [ALT] ≥3 times the [ULN], or ≥2 times the ULN) or Hy's Law events.
  19. Evidence or history of drug or alcohol abuse in the 2 years prior to Enrollment at Screening Visit 1a or a positive drug or alcohol test at Screening Visit 1b.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,902 participants (actual)

Study arms

  • Experimental
    Investigational Test Product

    Fluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation

    Drug: Fluticasone propionate pressurized metered dose inhaler

  • Active comparator
    Reference Listed Drug

    Flovent HFA pressurized metered dose inhaler, 110 mcg per actuation

    Drug: Flovent HFA pressurized metered dose inhaler

  • Placebo comparator
    Placebo

    Placebo pressurized metered dose inhaler, no active content

    Drug: Placebo pressurized metered dose inhaler

Interventions

  • DrugFluticasone propionate pressurized metered dose inhaler

    110 mcg per actuation

  • DrugFlovent HFA pressurized metered dose inhaler

    110 mcg per actuation

    Also known as: Fluticasone propionate pressurized metered dose inhaler

  • DrugPlacebo pressurized metered dose inhaler

    no active content

06

What researchers measure

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Superiority over Placebo

    To confirm the Test and Reference listed Drug products are statistically superior to placebo (p\< 0.05) on the primary study endpoint.

    Time frame: Approximately 4 Weeks

07

Study locations

1 site
  • Site 1
    Spartanburg, South Carolina 29303, United States
08

References and documents

Individual participant data

Plan to share: No — Participant data will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03879837
Lead sponsor
Actavis Inc.
Responsible party
Sponsor
First posted
Mar 19, 2019
Start date
Mar 25, 2019
Primary completion
May 28, 2021
Completion
Jul 9, 2021
Last update
Sep 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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