Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma

NCT02141854 | Completed Phase 3 Results

• 2 other identifiers: FSS-AS-300172014-000923-25
• Study Type: interventional
• Target: 882
• Locations: 9 countries
• Sites: 154

Brief Summary

The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12

  A subset of patients performed postdose serial spirometry. Data from these assessments were used to analyze the primary endpoint of baseline-adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.

  Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours

• Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12

  Trough FEV1 is a morning spirometry taken predose and pre-rescue bronchodilator. The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1).

  Day 1 (predose, baseline), Week 12

Secondary Outcomes (7)

• Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment

  Days -6 to Day 1 (predose, baseline), Day 1 (postdose) daily until Week 12

• Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

  Days -6 to Day 1 (predose, baseline), to Week 12

• Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period

  Days -6 to Day 1 (predose, baseline), up to week 12

• Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12

  up to Week 12 of the Treatment Period

• Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old

  Day 1 (predose, baseline), end of trial (up to week 12)

Study Arms (5)

FS MDPI 200 / 12.5 mcg

EXPERIMENTAL

Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.

Drug: FS MDPI; Drug: Albuterol/salmeterol HFA MDI

FS MDPI 100 / 12.5 mcg

EXPERIMENTAL

Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.

Drug: FS MDPI; Drug: Albuterol/salmeterol HFA MDI

Fp MDPI 200 mcg

EXPERIMENTAL

Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.

Drug: Fp MDPI; Drug: Albuterol/salmeterol HFA MDI

Fp MDPI 100 mcg

EXPERIMENTAL

Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.

Drug: Fp MDPI; Drug: Albuterol/salmeterol HFA MDI

Placebo MDPI

PLACEBO COMPARATOR

Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.

Drug: Placebo MDPI; Drug: Albuterol/salmeterol HFA MDI

Interventions

FS MDPI DRUG

FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to either fluticasone propionate/salmeterol MDPI 200/12.5 mcg or fluticasone propionate/salmeterol MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg. Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Also known as: fluticasone propionate, inhaled corticosteroid, salmeterol xinafoate, β2 adrenoceptor agonist

FS MDPI 100 / 12.5 mcg; FS MDPI 200 / 12.5 mcg

Fp MDPI DRUG

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to either 200 mcg or 100 mcg of Fp one inhalation twice a day for a total daily dose of 400 mcg or 200 mcg. Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Also known as: fluticasone propionate, inhaled corticosteroid

Fp MDPI 100 mcg; Fp MDPI 200 mcg

Placebo MDPI DRUG

The placebo multidose dry powder inhaler (MDPI) was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart). Patients were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Also known as: inert powder

Placebo MDPI

Albuterol/salmeterol HFA MDI DRUG

Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Also known as: short-acting β2-adrenergic agonists

FS MDPI 100 / 12.5 mcg; FS MDPI 200 / 12.5 mcg; Fp MDPI 100 mcg; Fp MDPI 200 mcg; Placebo MDPI

Eligibility Criteria

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

You may qualify if:

• Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of 40 to 85% of their predicted normal value.
• Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use) for a minimum of 8 weeks before the Screening Visit (SV) and a qualifying dose of an inhaled corticosteroid (ICS). The ICS may be either as ICS monotherapy or as an ICS/long-acting beta agonist (LABA) combination. The ICS component of the patient's asthma therapy should be stable for a minimum of 1 month before providing consent.
• Reversibility of Disease: Patients must have at least 15% reversibility (all patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV. Note: Patients who do not qualify for the study due to failure to meet reversibility will be permitted to perform a retest once within 7 days.
• Patients must provide written informed consent/assent.. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable). Note: Age requirements are as specified by local regulations.
• Outpatient \>= 12 years of age on the date of consent/assent. In countries where the local regulations permit enrollment of adult patients only, patients must be 18 years of age and older.
• Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days.
• The patient is able to perform acceptable and repeatable spirometry.
• The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter.
• The patient is able to use a metered dose inhaler (MDI) device without a spacer device and a multidose dry powder inhaler (MDPI) device.
• The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the screening visit (SV) and before all treatment visits.
• The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements.
• SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol for the duration of the study.
• Female patients may not be pregnant, breastfeeding, or attempting to become pregnant.
• other criteria may apply, please contact the investigator for more information

You may not qualify if:

• A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures).
• The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
• The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV.
• The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI.
• The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose).
• The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV.
• The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
• The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
• The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV.
• The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
• The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV.
• The patient has used immunosuppressive medications within 4 weeks before the SV.
• The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications.
• The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
• The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (154)

Teva Investigational Site 12429

Birmingham, Alabama, United States

Location

Teva Investigational Site 12599

Little Rock, Alaska, United States

Location

Teva Investigational Site 12609

Phoenix, Arizona, United States

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Teva Investigational Site 12445

Costa Mesa, California, United States

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Teva Investigational Site 12454

Encinitas, California, United States

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Teva Investigational Site 12456

Fresno, California, United States

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Teva Investigational Site 12461

Fullerton, California, United States

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Teva Investigational Site 12410

Huntington Beach, California, United States

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Teva Investigational Site 12452

Huntington Beach, California, United States

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Teva Investigational Site 12417

Long Beach, California, United States

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Teva Investigational Site 13017

Mission Viejo, California, United States

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Teva Investigational Site 12462

Rancho Mirage, California, United States

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Teva Investigational Site 12411

Rolling Hills Estates, California, United States

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Teva Investigational Site 13018

San Diego, California, United States

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Teva Investigational Site 12413

San Jose, California, United States

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Teva Investigational Site 12403

Stockton, California, United States

Location

Teva Investigational Site 12444

Upland, California, United States

Location

Teva Investigational Site 12999

Vista, California, United States

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Teva Investigational Site 12405

Centennial, Colorado, United States

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Teva Investigational Site 12419

Centennial, Colorado, United States

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Teva Investigational Site 13000

Colorado Springs, Colorado, United States

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Teva Investigational Site 12459

Waterbury, Connecticut, United States

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Teva Investigational Site 13004

Largo, Florida, United States

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Teva Investigational Site 12414

Miami, Florida, United States

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Teva Investigational Site 12437

Miami, Florida, United States

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Teva Investigational Site 12427

Orlando, Florida, United States

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Teva Investigational Site 12423

Ormond Beach, Florida, United States

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Teva Investigational Site 12604

Panama City, Florida, United States

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Teva Investigational Site 13316

Tamarac, Florida, United States

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Teva Investigational Site 12606

Winter Park, Florida, United States

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Teva Investigational Site 12435

Savannah, Georgia, United States

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Teva Investigational Site 13315

Eagle, Idaho, United States

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Teva Investigational Site 12439

River Forest, Illinois, United States

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Teva Investigational Site 12449

Shiloh, Illinois, United States

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Teva Investigational Site 12457

South Bend, Indiana, United States

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Teva Investigational Site 12446

Bangor, Maine, United States

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Teva Investigational Site 12602

Columbia, Maryland, United States

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Teva Investigational Site 12432

Fall River, Massachusetts, United States

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Teva Investigational Site 12441

North Dartmouth, Massachusetts, United States

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Teva Investigational Site 12466

North Dartmouth, Massachusetts, United States

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Teva Investigational Site 13001

Royal Oak, Michigan, United States

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Teva Investigational Site 12428

Ypsilanti, Michigan, United States

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Teva Investigational Site 13020

Minneapolis, Minnesota, United States

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Teva Investigational Site 12451

Columbia, Missouri, United States

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Teva Investigational Site 12421

Rolla, Missouri, United States

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Teva Investigational Site 12412

St Louis, Missouri, United States

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Teva Investigational Site 12453

St Louis, Missouri, United States

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Teva Investigational Site 12610

Missoula, Montana, United States

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Teva Investigational Site 13021

Las Vegas, Nevada, United States

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Teva Investigational Site 12409

Skillman, New Jersey, United States

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Teva Investigational Site 12464

Brooklyn, New York, United States

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Teva Investigational Site 12603

The Bronx, New York, United States

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Teva Investigational Site 12430

Charlotte, North Carolina, United States

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Teva Investigational Site 12407

Raleigh, North Carolina, United States

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Teva Investigational Site 12415

Canton, Ohio, United States

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Teva Investigational Site 12455

Cincinnati, Ohio, United States

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Teva Investigational Site 12463

Cincinnati, Ohio, United States

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Teva Investigational Site 12460

Middleburg Heights, Ohio, United States

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Teva Investigational Site 12426

Edmond, Oklahoma, United States

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Teva Investigational Site 13008

Oklahoma City, Oklahoma, United States

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Teva Investigational Site 12406

Medford, Oregon, United States

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Teva Investigational Site 12442

Portland, Oregon, United States

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Teva Investigational Site 12563

Normal Square, Pennsylvania, United States

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Teva Investigational Site 12443

Pittsburgh, Pennsylvania, United States

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Teva Investigational Site 12438

Upland, Pennsylvania, United States

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Teva Investigational Site 12408

Charleston, South Carolina, United States

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Teva Investigational Site 12431

Greenville, South Carolina, United States

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Teva Investigational Site 12465

Mt. Pleasant, South Carolina, United States

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Teva Investigational Site 12467

Mt. Pleasant, South Carolina, United States

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Teva Investigational Site 12420

Orangeburg, South Carolina, United States

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Teva Investigational Site 12433

Rock Hill, South Carolina, United States

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Teva Investigational Site 13003

Knoxville, Tennessee, United States

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Teva Investigational Site 12425

Arlington, Texas, United States

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Teva Investigational Site 12416

Dallas, Texas, United States

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Teva Investigational Site 12418

Dallas, Texas, United States

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Teva Investigational Site 12440

El Paso, Texas, United States

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Teva Investigational Site 12447

Killeen, Texas, United States

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Teva Investigational Site 13318

San Antonio, Texas, United States

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Teva Investigational Site 13002

Sugar Land, Texas, United States

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Teva Investigational Site 12424

Waco, Texas, United States

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Teva Investigational Site 12422

South Burlington, Vermont, United States

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Teva Investigational Site 12605

Richmond, Virginia, United States

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Teva Investigational Site 12436

Spokane, Washington, United States

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Teva Investigational Site 12564

Tacoma, Washington, United States

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Teva Investigational Site 12448

Greenfield, Wisconsin, United States

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Teva Investigational Site 11072

Toronto, Ontario, Canada

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Teva Investigational Site 11075

Vancouver, Quebec, Canada

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Teva Investigational Site 54096

Jindřichův Hradec, Czechia

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Teva Investigational Site 54098

Prague, Czechia

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Teva Investigational Site 54095

Rokycany, Czechia

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Teva Investigational Site 54094

Strakonice, Czechia

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Teva Investigational Site 51149

Budapest, Hungary

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Teva Investigational Site 51155

Budapest, Hungary

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Teva Investigational Site 51157

Budapest, Hungary

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Teva Investigational Site 51161

Budapest, Hungary

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Teva Investigational Site 51154

Debrecen, Hungary

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Teva Investigational Site 51152

Deszk, Hungary

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Teva Investigational Site 51170

Dombóvár, Hungary

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Teva Investigational Site 51158

Kiskunhalas, Hungary

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Teva Investigational Site 51153

Miskolc, Hungary

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Teva Investigational Site 51156

Mosdós, Hungary

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Teva Investigational Site 51150

Nyíregyháza, Hungary

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Teva Investigational Site 51151

Nyíregyháza, Hungary

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Teva Investigational Site 51148

Százhalombatta, Hungary

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Teva Investigational Site 51146

Szeged, Hungary

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Teva Investigational Site 51162

Szigetvár, Hungary

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Teva Investigational Site 51147

Szombathely, Hungary

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Teva Investigational Site 51176

Tatabánya, Hungary

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Teva Investigational Site 51177

Törökbálint, Hungary

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Teva Investigational Site 53199

Bialystok, Poland

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Teva Investigational Site 53200

Bialystok, Poland

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Teva Investigational Site 53202

Bialystok, Poland

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Teva Investigational Site 53208

Bialystok, Poland

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Teva Investigational Site 53210

Bydgoszcz, Poland

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Teva Investigational Site 53227

Bydgoszcz, Poland

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Teva Investigational Site 53225

Dębica, Poland

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Teva Investigational Site 53203

Gdansk, Poland

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Teva Investigational Site 53195

Krakow, Poland

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Teva Investigational Site 53197

Krakow, Poland

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Teva Investigational Site 53205

Krakow, Poland

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Teva Investigational Site 53228

Lodz, Poland

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Teva Investigational Site 53240

Lodz, Poland

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Teva Investigational Site 53201

Lódz, Poland

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Teva Investigational Site 53229

Lódz, Poland

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Teva Investigational Site 53241

Lublin, Poland

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Teva Investigational Site 53206

Poznan, Poland

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Teva Investigational Site 53211

Poznan, Poland

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Teva Investigational Site 53230

Strzelce Opolskie, Poland

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Teva Investigational Site 53196

Tarnów, Poland

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Teva Investigational Site 53222

Warsaw, Poland

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Teva Investigational Site 53198

Wroclaw, Poland

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Teva Investigational Site 53224

Wroclaw, Poland

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Teva Investigational Site 50255

Chelyabinsk, Russia

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Teva Investigational Site 50241

Kazan', Russia

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Teva Investigational Site 50250

Moscow, Russia

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Teva Investigational Site 50252

Moscow, Russia

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Teva Investigational Site 50242

Saint Petersburg, Russia

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Teva Investigational Site 50245

Saint Petersburg, Russia

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Teva Investigational Site 50246

Saint Petersburg, Russia

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Teva Investigational Site 50254

Saratov, Russia

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Teva Investigational Site 50244

Tomsk, Russia

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Teva Investigational Site 50251

Voronezh, Russia

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Teva Investigational Site 50275

Yaroslavl, Russia

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Teva Investigational Site 50243

Yekaterinburg, Russia

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Teva Investigational Site 90011

Berea, South Africa

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Teva Investigational Site 90015

Bloemfontein, South Africa

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Teva Investigational Site 90012

Cape Town, South Africa

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Teva Investigational Site 90013

Centurion, South Africa

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Teva Investigational Site 90016

Middelburg, South Africa

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Teva Investigational Site 90014

Pretoria, South Africa

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Teva Investigational Site 12404

Papillion, NE, Thailand

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Teva Investigational Site 58133

Kharkiv, Ukraine

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Teva Investigational Site 58135

Kharkiv, Ukraine

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Teva Investigational Site 58132

Kyiv, Ukraine

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Related Publications (2)

• Sher LD, Yiu G, Sakov A, Liu S, Caracta CF. Fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers compared with placebo for persistent asthma. Allergy Asthma Proc. 2017 Sep 21;38(5):343-353. doi: 10.2500/aap.2017.38.4069. Epub 2017 Jun 21.

  PMID: 28639542 DERIVED

• Miller DS, Yiu G, Hellriegel ET, Steinfeld J. Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma. Allergy Asthma Proc. 2016 Jul;37(4):291-301. doi: 10.2500/aap.2016.37.3963. Epub 2016 May 27.

  PMID: 27216137 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Salmeterol Xinafoate; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 20, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 9, 2021
• Results First Posted: April 12, 2017

Record last verified: 2021-11

Locations

PL (23); CA (2); RU (12); US (85); CZ (4); UA (3); ZA (6); HU (18); TH (1)