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AzTrials

AsthmaPhase 3NCT02139644

Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma

A Phase 3 study testing FS MDPI, Fp MDPI and albuterol/salbutamol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 140 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
FS MDPI, Fp MDPI and albuterol/salbutamol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
787 participants
Where
140 sitesin 8 countries
Study dates
Jun 2014to Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 low-dose inhaled corticosteroid (ICS). The low-dose 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 months 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 Institutes 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.
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  • 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 MDI device without a spacer device and a 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 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

Who cannot join

  • A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnea, 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.
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  • 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.
  • Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients on stable immunotherapy may be considered for inclusion.
  • 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.
  • The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
  • A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
  • The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
  • other criteria may apply, please contact the investigator for more information

Trial locations and contacts

140 sites in 8 countries.

140 sites in 8 countries

United States76 sites

  • Teva Investigational Site 12399

    Baltimore, Maryland

  • Teva Investigational Site 12391

    Bethesda, Maryland

  • Teva Investigational Site 12397

    Birmingham, Alabama

  • Teva Investigational Site 12587

    Brooklyn, New York

  • Teva Investigational Site 12374

    Canton, Ohio

  • Teva Investigational Site 12379

    Centennial, Colorado

  • Teva Investigational Site 12386

    Centennial, Colorado

  • Teva Investigational Site 12480

    Cincinnati, Ohio

  • Teva Investigational Site 12492

    Cincinnati, Ohio

  • Teva Investigational Site 12493

    Clearwater, Florida

  • Teva Investigational Site 12596

    Colorado Springs, Colorado

  • Teva Investigational Site 12589

    Columbia, Maryland

  • Teva Investigational Site 12395

    Cypress, California

  • Teva Investigational Site 12990

    Cypress, Texas

  • Teva Investigational Site 12373

    Dallas, Texas

  • Teva Investigational Site 12997

    Decatur, Georgia

  • Teva Investigational Site 12377

    Edmond, Oklahoma

  • Teva Investigational Site 12402

    El Paso, Texas

  • Teva Investigational Site 12476

    Encinitas, California

  • Teva Investigational Site 12396

    Fall River, Massachusetts

  • Teva Investigational Site 12586

    Fountain Valley, California

  • Teva Investigational Site 12591

    Fresno, California

  • Teva Investigational Site 12375

    Glendale, Arizona

  • Teva Investigational Site 12389

    Greenville, South Carolina

  • Teva Investigational Site 12475

    Huntersville, North Carolina

  • Teva Investigational Site 12372

    Huntington Beach, California

  • Teva Investigational Site 12991

    Knoxville, Tennessee

  • Teva Investigational Site 12992

    Largo, Florida

  • Teva Investigational Site 12483

    Lenexa, Kansas

  • Teva Investigational Site 12584

    Longmont, Colorado

  • Teva Investigational Site 12365

    Los Angeles, California

  • Teva Investigational Site 12381

    Los Angeles, California

  • Teva Investigational Site 12401

    Los Angeles, California

  • Teva Investigational Site 12368

    Medford, Oregon

  • Teva Investigational Site 12376

    Miami, Florida

  • Teva Investigational Site 12390

    Miami, Florida

  • Teva Investigational Site 12487

    Middleburg Heights, Ohio

  • Teva Investigational Site 12378

    Milwaukee, Wisconsin

  • Teva Investigational Site 12394

    Mission Viejo, California

  • Teva Investigational Site 12594

    Missoula, Montana

  • Teva Investigational Site 12580

    Mt. Pleasant, South Carolina

  • Teva Investigational Site 12478

    Murray, Utah

  • Teva Investigational Site 12582

    New Braunfels, Texas

  • Teva Investigational Site 12384

    North Dartmouth, Massachusetts

  • Teva Investigational Site 12585

    North Dartmouth, Massachusetts

  • Teva Investigational Site 12385

    Ocean City, New Jersey

  • Teva Investigational Site 12398

    Orangeburg, South Carolina

  • Teva Investigational Site 12583

    Orlando, Florida

  • Teva Investigational Site 12400

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 12382

    Portland, Oregon

  • Teva Investigational Site 12364

    Raleigh, North Carolina

  • Teva Investigational Site 12490

    Rancho Mirage, California

  • Teva Investigational Site 12393

    Riverside, California

  • Teva Investigational Site 12369

    Rockville, Maryland

  • Teva Investigational Site 12485

    Rockville Centre, New York

  • Teva Investigational Site 12366

    Rolling Hills Estates, California

  • Teva Investigational Site 12363

    San Antonio, Texas

  • Teva Investigational Site 12482

    San Antonio, Texas

  • Teva Investigational Site 12383

    San Diego, California

  • Teva Investigational Site 12370

    San Jose, California

  • Teva Investigational Site 12392

    Savannah, Georgia

  • Teva Investigational Site 12592

    Shiloh, Illinois

  • Teva Investigational Site 12380

    Skillman, New Jersey

  • Teva Investigational Site 12388

    South Burlington, Vermont

  • Teva Investigational Site 12494

    St Louis, Missouri

  • Teva Investigational Site 12595

    St Louis, Missouri

  • Teva Investigational Site 12371

    Stockton, California

  • Teva Investigational Site 12488

    Sylvania, Ohio

  • Teva Investigational Site 12481

    Tallahassee, Florida

  • Teva Investigational Site 12579

    Upland, California

  • Teva Investigational Site 12473

    Upland, Pennsylvania

  • Teva Investigational Site 12477

    Waco, Texas

  • Teva Investigational Site 12484

    Waterbury, Connecticut

  • Teva Investigational Site 12590

    Waterbury, Connecticut

  • Teva Investigational Site 12491

    Winter Park, Florida

  • Teva Investigational Site 12588

    Ypsilanti, Michigan

Other trials in United States

Poland22 sites

  • Teva Investigational Site 53182

    Bialystok

  • Teva Investigational Site 53183

    Bialystok

  • Teva Investigational Site 53185

    Bialystok

  • Teva Investigational Site 53191

    Bialystok

  • Teva Investigational Site 53187

    Bienkówka

  • Teva Investigational Site 53219

    Bydgoszcz

  • Teva Investigational Site 53217

    Dębica

  • Teva Investigational Site 53178

    Krakow

  • Teva Investigational Site 53180

    Krakow

  • Teva Investigational Site 53188

    Krakow

  • Teva Investigational Site 53220

    Lodz

  • Teva Investigational Site 53235

    Lodz

  • Teva Investigational Site 53221

    Lódz

  • Teva Investigational Site 53237

    Lublin

  • Teva Investigational Site 53194

    Poznan

  • Teva Investigational Site 53234

    Poznan

  • Teva Investigational Site 53233

    Strzelce Opolskie

  • Teva Investigational Site 53179

    Tarnów

  • Teva Investigational Site 53218

    Tarnów

  • Teva Investigational Site 53193

    Warsaw

  • Teva Investigational Site 53181

    Wroclaw

  • Teva Investigational Site 53189

    Wroclaw

Other trials in Poland

Hungary15 sites

  • Teva Investigational Site 51134

    Budapest

  • Teva Investigational Site 51143

    Budapest

  • Teva Investigational Site 51144

    Budapest

  • Teva Investigational Site 51140

    Debrecen

  • Teva Investigational Site 51142

    Deszk

  • Teva Investigational Site 51165

    Dombóvár

  • Teva Investigational Site 51145

    Kiskunhalas

  • Teva Investigational Site 51141

    Miskolc

  • Teva Investigational Site 51133

    Mosdós

  • Teva Investigational Site 51136

    Nyíregyháza

  • Teva Investigational Site 51139

    Nyíregyháza

  • Teva Investigational Site 51163

    Sopron

  • Teva Investigational Site 51137

    Szeged

  • Teva Investigational Site 51164

    Szigetvár

  • Teva Investigational Site 51138

    Szombathely

Other trials in Hungary

Russia10 sites

  • Teva Investigational Site 50236

    Chelyabinsk

  • Teva Investigational Site 50227

    Kazan'

  • Teva Investigational Site 50234

    Moscow

  • Teva Investigational Site 50238

    Moscow

  • Teva Investigational Site 50230

    Novosibirsk

  • Teva Investigational Site 50224

    Saint Petersburg

  • Teva Investigational Site 50231

    Saint Petersburg

  • Teva Investigational Site 50233

    Voronezh

  • Teva Investigational Site 50237

    Yaroslavl

  • Teva Investigational Site 50226

    Yekaterinburg

Other trials in Russia

South Africa6 sites

  • Teva Investigational Site 90002

    Cape Town

  • Teva Investigational Site 90008

    Cape Town

  • Teva Investigational Site 90005

    Centurion

  • Teva Investigational Site 90001

    Johannesburg

  • Teva Investigational Site 90003

    Middelburg

  • Teva Investigational Site 90007

    Pretoria

Other trials in South Africa

Ukraine5 sites

  • Teva Investigational Site 58125

    Kharkiv

  • Teva Investigational Site 58126

    Kharkiv

  • Teva Investigational Site 58127

    Kyiv

  • Teva Investigational Site 58128

    Kyiv

  • Teva Investigational Site 58129

    Vinnytsia

Other trials in Ukraine

Canada3 sites

  • Teva Investigational Site 11067

    Montreal, Quebec

  • Teva Investigational Site 11065

    Toronto, Ontario

  • Teva Investigational Site 11068

    Vancouver, Quebec

Other trials in Canada

Czechia3 sites

  • Teva Investigational Site 54084

    Neratovice

  • Teva Investigational Site 54088

    Prague

  • Teva Investigational Site 54087

    Rokycany

Other trials in Czechia

About this study

Official title: A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptomatic Despite Low-dose or or Mid-dose Inhaled Corticosteroid Therapy

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

Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel.

Conditions
Asthma
Being tested
FS MDPI, Fp MDPI, Placebo MDPI, albuterol/salbutamol, Beclomethasone dipropionate
Keywords
fluticasone propionate, multidose dry powder inhaler
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FS MDPIDrug

    Also called fluticasone propionate, inhaled corticosteroid, salmeterol xinafoate, β2 adrenoceptor agonist

    FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) 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 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.

    Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

  • Fp MDPIDrug

    Also called fluticasone propionate, inhaled corticosteroid

    Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate 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 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.

    Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

  • Placebo MDPIDrug

    Also called inert powder

    Placebo administered via a multidose dry powder inhaler (MDPI) one puff in the morning and one puff in the evening for 12 weeks.

  • albuterol/salbutamolDrug

    Also called short-acting β2-adrenergic agonists

    A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

  • Beclomethasone dipropionateDrug

    Also called QVAR

    QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.

Study groups in NCT02139644
Study groupRoleWhat they receive
FS MDPI 100 / 12.5 mcgExperimentalPatients 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. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Receives: Drug: FS MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate
FS MDPI 50 / 12.5 mcgExperimentalPatients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Receives: Drug: FS MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate
Fp MDPI 100 mcgExperimentalPatients 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 for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate
Fp MDPI 50 mcgExperimentalPatients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg for a total daily dose of 100 mcg for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate
Placebo MDPIPlacebo comparatorThe placebo multidose dry powder inhaler 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). Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Receives: Drug: Placebo MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. 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.

    Measured: 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

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

    Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.

    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).

    Measured: Day 1 (predose, baseline), Week 12

Secondary outcomes (7)

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

    Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary. The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week.

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

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

    The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary (range 0-9).

    Daytime Symptom Score:

    0=No symptoms

    1. Symptoms for 1 short period
    2. Symptoms for 2+ short periods
    3. Symptoms for most of the day - did not affect normal daily activities
    4. Symptoms for most of the day - did affect normal daily activities
    5. Symptoms so severe that I could not go to work or perform normal daily activities

    Nighttime Symptom Score (determined in the AM):

    0=No symptoms

    1. Symptoms causing me to wake once (or wake early)
    2. Symptoms causing me to wake twice or more (including waking early)
    3. Symptoms causing me to be awake for most of the night
    4. Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM).

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

  3. 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

    Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week. The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures.

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

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

    The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.

    Measured: up to Week 12 of the Treatment Period

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

    The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self-administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient's quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score of 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.

    Positive change from baseline scores indicate improved quality of life.

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

  6. Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1

    A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Baseline FEV1 was the average of 2 FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, baseline was treated as missing. Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.

    Values of 9999 indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.

    Measured: Day 1 of the Treatment Period (predose and postdose)

  7. Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period

    An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: Day 1 to Week 12 of the Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
787 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02139644
Sponsor's protocol ID
FSS-AS-301
Other IDs
2014-001149-25, 2014
Status last verified
Nov 2021
First submitted
9 May 2014
Last updated
12 Nov 2021
Data monitoring committee
No

Publications

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PubMed 36472162

  • Raphael G, Yiu G, Sakov A, Liu S, Caracta C. Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older. J Asthma. 2018 Jun;55(6):640-650. doi: 10.1080/02770903.2017.1350971. Epub 2017 Aug 31.

    PubMed 28763243

  • 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.

    PubMed 27216137

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FS MDPI, Fp MDPI and albuterol/salbutamol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 140 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Poland, Hungary, Russia, South Africa and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12 (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02139644, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.

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