AzTrials
AzTrials

AsthmaPhase 2NCT01576718

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications

A Phase 2 study testing Fp MDPI, Flovent Diskus and albuterol/salbutamol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 300 sites in 19 countries.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Fp MDPI, Flovent Diskus and albuterol/salbutamol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
889 participants
Where
300 sitesin 19 countries
Study dates
Apr 2012to Oct 2013
Phase
Phase 2
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

  • Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
  • Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
  • General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
  • Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
  • Severity of Disease:
  • A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects. ATS/ERS 2005 criteria for acceptability, reproducibility, and end of test must be met for spirometry
Show all 36Show fewer
  • Reversibility of Disease: Demonstrated a ≥12% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥12% then the subject is not eligible for the study and will not be allowed to re-screen. Reversibility values of 11.50 - 11.99 will be rounded to 12. Documented historical reversibility of ≥ 12 % within 3 months of the Screening Visit will be accepted.
  • Current Asthma Therapy: Subjects will be required to be on a short acting β2 agonist and inhaled corticosteroid for a minimum of 8 weeks before the Screening Visit and have been maintained on a stable dose of inhaled corticosteroids for four weeks prior to the Screening Visit at one of the following doses:
  • Fluticasone propionate HFA MDI ≥ 880 mcg/day
  • Fluticasone propionate DPI≥ 1000 mcg/day
  • Beclomethasone dipropionate DPI ≥ 2000 mcg/day
  • Beclomethasone dipropionate HFA (QVAR)≥ 640 mcg/day
  • Beclomethasone dipropionate HFA (Clenil Modulite)≥ 2000 mcg/day
  • Budesonide DPI ≥ 1600 mcg/day
  • Budesonide MDI ≥ 1600 mcg/day
  • Flunisolide ≥ 2000 mcg/day
  • Triamcinolone acetonide ≥ 2000 mcg /day
  • Mometasone furoate DPI ≥ 880 mcg/day
  • Ciclesonide HFA MDI ≥ 640 mcg/day
  • Exception 1: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS/LABA therapy and the subject provides consent, subjects on inhaled Fluticasone propionate/salmeterol DPI ≥ 1000 mcg/day, or Fluticasone propionate/salmeterol HFA ≥ 880 mcg/day, or Fluticasone propionate/Formoterol ≥ 1000 mcg/day,or Beclomethasone dipropionate/Formoterol ≥ 400 mcg/day, or Budesonide/formoterol HFA ≥ 640 mcg/day, or Budesonide/formoterol DPI ≥ 800 mcg/day, or Mometasone furoate/formoterol MDI ≥ 800 mcg/day or subjects on a qualifying ICS dose plus a long-acting β2-agonists (LABA) administered via separate inhalers, may be switched to a qualifying dose of fluticasone propionate provided the subjects will not participate in the PK portion of the study.
  • Exception 2: Subjects on a qualifying dose of fluticasone propionate who wish to participate in the PK portion of the study and who provide consent may have their fluticasone propionate switched to a different qualifying ICS (non-fluticasone propionate) at a pre-screening visit. The subject will be required to return to the clinic to complete the Screening Visit following a 1-week washout period.
  • Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of it's use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting β2 sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
  • If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of
  • Non-childbearing potential, defined as:
  • Before menarche, or
  • 1 year post-menopausal, or
  • Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy), or
  • Congenital sterility, or
  • Diagnosed as infertile and not undergoing treatment to reverse infertility or is of
  • Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
  • Systemic contraception used for 1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®), or
  • Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide), or
  • Intrauterine device (IUD) or
  • Monogamous with a vasectomized male partner or is of
  • Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active
  • 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 (visits, record-keeping, etc).

Who cannot join

  • History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
  • Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.
  • Any asthma exacerbation requiring oral corticosteroids within 1 month of the Screening Visit. A subject must not have had any hospitalization for asthma within 2 month prior to the Screening Visit.
  • Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular inhaled corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular inhaled corticosteroid maintenance treatment, or the addition of other asthma medications.
  • Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
  • Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Show all 28Show fewer
  • Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:
  • Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit)
  • Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years
  • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100)
  • Stroke within 3 months prior to the Screening Visit
  • Immunologic compromise
  • History of a positive test for HIV, hepatitis B or hepatitis C infection.
  • Untreated oral candidiasis at the Screening Visit. Subjects with clinical visual evidence of oral candidiasis and who agree to receive treatment and comply with appropriate medical monitoring may enter the study
  • History of any adverse reaction to any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose).
  • History of severe allergy to milk protein.
  • Use of systemic, oral or depot corticosteroids within 4 weeks prior to the Screening Visit
  • Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted
  • Use of intranasal corticosteroids or ocular corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted
  • Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
  • Immunotherapy for the treatment of allergy at a stable maintenance dose for at least 90 days prior to the Screening Visit and which will remain at a stable dose without escalation throughout the study is permitted.
  • Use of Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit. Strong and moderate CYP3A4 inhibitors are prohibited and weak CYP3A4 are allowed.
  • History of alcohol or drug abuse within two years preceding the Screening Visit.
  • Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
  • Study participation by clinical investigator site employees and/or their immediate relatives.
  • Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
  • Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
  • Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.

Trial locations and contacts

300 sites in 19 countries.

300 sites in 19 countries

United States148 sites

  • Teva Investigational Site 11504

    Albany, Georgia

  • Teva Investigational Site 11503

    Albuquerque, New Mexico

  • Teva Investigational Site 10509

    Altoona, Pennsylvania

  • Teva Investigational Site 10598

    Ashland, Oregon

  • Teva Investigational Site 10573

    Bakersfield, California

  • Teva Investigational Site 11548

    Baltimore, Maryland

  • Teva Investigational Site 10564

    Bangor, Maine

  • Teva Investigational Site 10518

    Bellevue, Nebraska

  • Teva Investigational Site 11561

    Bellingham, Washington

  • Teva Investigational Site 10504

    Birmingham, Alabama

  • Teva Investigational Site 10519

    Boerne, Texas

  • Teva Investigational Site 10556

    Boynton Beach, Florida

  • Teva Investigational Site 11513

    Brandon, Florida

  • Teva Investigational Site 10538

    Brockton, Massachusetts

  • Teva Investigational Site 10587

    Brooklyn, New York

  • Teva Investigational Site 10522

    Canton, Ohio

  • Teva Investigational Site 10545

    Centennial, Colorado

  • Teva Investigational Site 10526

    Charleston, South Carolina

  • Teva Investigational Site 11547

    Charleston, South Carolina

  • Teva Investigational Site 10559

    Cherry Hill, New Jersey

  • Teva Investigational Site 10507

    Cincinnati, Ohio

  • Teva Investigational Site 10523

    Cincinnati, Ohio

  • Teva Investigational Site 11507

    Clearwater, Florida

  • Teva Investigational Site 10572

    Colorado Springs, Colorado

  • Teva Investigational Site 11562

    Columbia, Missouri

  • Teva Investigational Site 11563

    Columbia, Missouri

  • Teva Investigational Site 10511

    Columbus, Georgia

  • Teva Investigational Site 11510

    Columbus, Georgia

  • Teva Investigational Site 11572

    Columbus, Georgia

  • Teva Investigational Site 10544

    Columbus, Ohio

  • Teva Investigational Site 11518

    Costa Mesa, California

  • Teva Investigational Site 10541

    Dallas, Texas

  • Teva Investigational Site 10542

    Dallas, Texas

  • Teva Investigational Site 11521

    Dayton, Ohio

  • Teva Investigational Site 10533

    Denver, Colorado

  • Teva Investigational Site 11531

    Denver, Colorado

  • Teva Investigational Site 11542

    Denver, Colorado

  • Teva Investigational Site 11566

    Edison, New Jersey

  • Teva Investigational Site 10548

    El Paso, Texas

  • Teva Investigational Site 11552

    El Paso, Texas

  • Teva Investigational Site 10502

    Fairfax, Virginia

  • Teva Investigational Site 11546

    Fort Myers, Florida

  • Teva Investigational Site 11512

    Fort Worth, Texas

  • Teva Investigational Site 10590

    Fountain Valley, California

  • Teva Investigational Site 11527

    Goodyear, Arizona

  • Teva Investigational Site 10551

    Granada Hills, California

  • Teva Investigational Site 10570

    Greenfield, Wisconsin

  • Teva Investigational Site 11559

    Greenfield, Wisconsin

  • Teva Investigational Site 11526

    Hialeah, Florida

  • Teva Investigational Site 10501

    Hillsborough, New Jersey

  • Teva Investigational Site 10565

    Homewood, Alabama

  • Teva Investigational Site 11565

    Houston, Texas

  • Teva Investigational Site 11568

    Houston, Texas

  • Teva Investigational Site 11520

    Huntington Beach, California

  • Teva Investigational Site 11545

    Huntington Beach, California

  • Teva Investigational Site 11558

    Indianapolis, Indiana

  • Teva Investigational Site 10584

    Iowa City, Iowa

  • Teva Investigational Site 11525

    Kissimmee, Florida

  • Teva Investigational Site 10510

    Largo, Maryland

  • Teva Investigational Site 11571

    Las Vegas, Nevada

  • Teva Investigational Site 10568

    Lawrenceville, Georgia

  • Teva Investigational Site 11528

    Layton, Utah

  • Teva Investigational Site 10591

    Lexington, Kentucky

  • Teva Investigational Site 10586

    Lilburn, Georgia

  • Teva Investigational Site 10581

    Lincoln, Rhode Island

  • Teva Investigational Site 10547

    Long Beach, California

  • Teva Investigational Site 11549

    Los Angeles, California

  • Teva Investigational Site 11567

    Louisville, Kentucky

  • Teva Investigational Site 10595

    Manassas, Virginia

  • Teva Investigational Site 11543

    Medford, Oregon

  • Teva Investigational Site 10513

    Metairie, Louisiana

  • Teva Investigational Site 10537

    Miami, Florida

  • Teva Investigational Site 10553

    Miami, Florida

  • Teva Investigational Site 11508

    Miami, Florida

  • Teva Investigational Site 11514

    Miami, Florida

  • Teva Investigational Site 11516

    Miami, Florida

  • Teva Investigational Site 11530

    Miami, Florida

  • Teva Investigational Site 11570

    Miami, Florida

  • Teva Investigational Site 11505

    Middleburg Heights, Ohio

  • Teva Investigational Site 10503

    Mission Viejo, California

  • Teva Investigational Site 10520

    New York, New York

  • Teva Investigational Site 10532

    Newburgh, New York

  • Teva Investigational Site 10536

    Newport Beach, California

  • Teva Investigational Site 10546

    North Dartmouth, Massachusetts

  • Teva Investigational Site 10567

    North Syracuse, New York

  • Teva Investigational Site 10571

    Ocala, Florida

  • Teva Investigational Site 11550

    Ocean City, New Jersey

  • Teva Investigational Site 10560

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10574

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10579

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10550

    Omaha, Nebraska

  • Teva Investigational Site 11529

    Omaha, Nebraska

  • Teva Investigational Site 10540

    Orange, California

  • Teva Investigational Site 11551

    Orange, California

  • Teva Investigational Site 10583

    Orangeburg, South Carolina

  • Teva Investigational Site 11501

    Overland Park, Kansas

  • Teva Investigational Site 10578

    Palmdale, California

  • Teva Investigational Site 10555

    Philadelphia, Pennsylvania

  • Teva Investigational Site 10566

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 10531

    Plymouth, Minnesota

  • Teva Investigational Site 11557

    Portland, Oregon

  • Teva Investigational Site 10562

    Providence, Rhode Island

  • Teva Investigational Site 10576

    Provo, Utah

  • Teva Investigational Site 10585

    Redwood City, California

  • Teva Investigational Site 10508

    Richmond, Virginia

  • Teva Investigational Site 10512

    Rochester, New York

  • Teva Investigational Site 11538

    Rolling Hills Estates, California

  • Teva Investigational Site 11522

    Roseville, California

  • Teva Investigational Site 10515

    San Antonio, Texas

  • Teva Investigational Site 10569

    San Antonio, Texas

  • Teva Investigational Site 11517

    San Antonio, Texas

  • Teva Investigational Site 11519

    San Antonio, Texas

  • Teva Investigational Site 10582

    San Diego, California

  • Teva Investigational Site 11554

    San Diego, California

  • Teva Investigational Site 10563

    San Jose, California

  • Teva Investigational Site 11556

    Santa Monica, California

  • Teva Investigational Site 11537

    Sarasota, Florida

  • Teva Investigational Site 11539

    Savannah, Georgia

  • Teva Investigational Site 11541

    Seattle, Washington

  • Teva Investigational Site 10527

    South Bend, Indiana

  • Teva Investigational Site 10534

    South Burlington, Vermont

  • Teva Investigational Site 10593

    South Miami, Florida

  • Teva Investigational Site 10517

    Spartanburg, South Carolina

  • Teva Investigational Site 11515

    Spartanburg, South Carolina

  • Teva Investigational Site 10524

    Spokane, Washington

  • Teva Investigational Site 10552

    St Louis, Missouri

  • Teva Investigational Site 10575

    St Louis, Missouri

  • Teva Investigational Site 10589

    St Louis, Missouri

  • Teva Investigational Site 11532

    St Louis, Missouri

  • Teva Investigational Site 10543

    Stockbridge, Georgia

  • Teva Investigational Site 10506

    Stockton, California

  • Teva Investigational Site 10530

    Tacoma, Washington

  • Teva Investigational Site 11511

    Tacoma, Washington

  • Teva Investigational Site 11555

    Tallahassee, Florida

  • Teva Investigational Site 10554

    Tamarac, Florida

  • Teva Investigational Site 10539

    Tampa, Florida

  • Teva Investigational Site 10580

    The Bronx, New York

  • Teva Investigational Site 11502

    Troy, Michigan

  • Teva Investigational Site 10516

    Tucson, Arizona

  • Teva Investigational Site 11544

    Tulsa, Oklahoma

  • Teva Investigational Site 10521

    Upland, Pennsylvania

  • Teva Investigational Site 10525

    Valrico, Florida

  • Teva Investigational Site 11560

    Waco, Texas

  • Teva Investigational Site 10529

    Walnut Creek, California

  • Teva Investigational Site 10528

    Waterbury, Connecticut

  • Teva Investigational Site 10588

    West Orange, New Jersey

  • Teva Investigational Site 11569

    Wheat Ridge, Colorado

  • Teva Investigational Site 10577

    Wheaton, Maryland

Other trials in United States

Ukraine22 sites

  • Teva Investigational Site 80501

    Dnipropetrovsk

  • Teva Investigational Site 80513

    Dnipropetrovsk

  • Teva Investigational Site 80511

    Donetsk

  • Teva Investigational Site 80502

    Kharkiv

  • Teva Investigational Site 80503

    Kharkiv

  • Teva Investigational Site 80504

    Kyiv

  • Teva Investigational Site 80505

    Kyiv

  • Teva Investigational Site 80506

    Kyiv

  • Teva Investigational Site 80507

    Kyiv

  • Teva Investigational Site 80508

    Kyiv

  • Teva Investigational Site 80509

    Kyiv

  • Teva Investigational Site 80517

    Kyiv

  • Teva Investigational Site 80519

    Kyiv

  • Teva Investigational Site 80520

    Kyiv

  • Teva Investigational Site 80521

    Kyiv

  • Teva Investigational Site 80514

    Odesa

  • Teva Investigational Site 80516

    Simferopol

  • Teva Investigational Site 80512

    Vinnytsia

  • Teva Investigational Site 80515

    Yalta

  • Teva Investigational Site 80522

    Zaporizhia

  • Teva Investigational Site 80510

    Zaporizhzhya

  • Teva Investigational Site 80518

    Zaporizhzhya

Other trials in Ukraine

Hungary16 sites

  • Teva Investigational Site 36507

    Balassagyarmat

  • Teva Investigational Site 36504

    Budapest

  • Teva Investigational Site 36505

    Budapest

  • Teva Investigational Site 36514

    Csoma

  • Teva Investigational Site 36516

    Érd

  • Teva Investigational Site 36513

    Kaba

  • Teva Investigational Site 36515

    Kaposvár

  • Teva Investigational Site 36503

    Miskolc

  • Teva Investigational Site 36502

    Nyíregyháza

  • Teva Investigational Site 36510

    Siófok

  • Teva Investigational Site 36517

    Szarvas

  • Teva Investigational Site 36508

    Százhalombatta

  • Teva Investigational Site 36506

    Szeged

  • Teva Investigational Site 36509

    Szeged

  • Teva Investigational Site 36501

    Szombathely

  • Teva Investigational Site 36512

    Veszprém

Other trials in Hungary

Germany15 sites

  • Teva Investigational Site 70561

    Berlin

  • Teva Investigational Site 70564

    Bonn

  • Teva Investigational Site 70557

    Cottbus

  • Teva Investigational Site 70553

    Delitzsch

  • Teva Investigational Site 70558

    Frankfurt

  • Teva Investigational Site 70562

    Hamburg

  • Teva Investigational Site 70560

    Hanover

  • Teva Investigational Site 70555

    Leipzig

  • Teva Investigational Site 70556

    Magdeburg

  • Teva Investigational Site 70550

    München

  • Teva Investigational Site 70554

    München

  • Teva Investigational Site 70552

    Münster

  • Teva Investigational Site 70563

    Nuremberg

  • Teva Investigational Site 70551

    Rüdersdorf

  • Teva Investigational Site 70559

    Wiesbaden

Other trials in Germany

Israel12 sites

  • Teva Investigational Site 72511

    Ashkelon

  • Teva Investigational Site 72501

    Haifa

  • Teva Investigational Site 72512

    Haifa

  • Teva Investigational Site 72502

    Jerusalem

  • Teva Investigational Site 72504

    Jerusalem

  • Teva Investigational Site 72509

    Kfar Saba

  • Teva Investigational Site 72506

    Petah Tikva

  • Teva Investigational Site 72507

    Ramat Gan

  • Teva Investigational Site 72503

    Rehovot

  • Teva Investigational Site 72508

    Tel Aviv

  • Teva Investigational Site 72510

    Tel Aviv

  • Teva Investigational Site 72505

    Tsrifin

Other trials in Israel

Russia12 sites

  • Teva Investigational Site 70505

    Barnaul

  • Teva Investigational Site 70502

    Kazan'

  • Teva Investigational Site 70511

    Moscow

  • Teva Investigational Site 70512

    Moscow

  • Teva Investigational Site 70508

    Ryazan

  • Teva Investigational Site 70501

    Saint Petersburg

  • Teva Investigational Site 70504

    Saint Petersburg

  • Teva Investigational Site 70510

    Saint Petersburg

  • Teva Investigational Site 70509

    Samara

  • Teva Investigational Site 70507

    Smolensk

  • Teva Investigational Site 70506

    Tomsk

  • Teva Investigational Site 70503

    Yaroslavl

Other trials in Russia

Poland11 sites

  • Teva Investigational Site 48507

    Bialystok

  • Teva Investigational Site 48505

    Bydgoszcz

  • Teva Investigational Site 48506

    Grodzisk Mazowiecki

  • Teva Investigational Site 48501

    Lodz

  • Teva Investigational Site 48509

    Lodz

  • Teva Investigational Site 48513

    Lublin

  • Teva Investigational Site 48508

    Poznan

  • Teva Investigational Site 48512

    Poznan

  • Teva Investigational Site 48502

    Strzelce Opolskie

  • Teva Investigational Site 48503

    Tarnów

  • Teva Investigational Site 48504

    Wroclaw

Other trials in Poland

Spain11 sites

  • Teva Investigational Site 34507

    Aranjuez

  • Teva Investigational Site 34501

    Badalona

  • Teva Investigational Site 34502

    Barcelona

  • Teva Investigational Site 34510

    Barcelona

  • Teva Investigational Site 34509

    Bilbao

  • Teva Investigational Site 34506

    Lleida

  • Teva Investigational Site 34505

    Madrid

  • Teva Investigational Site 34503

    Salt

  • Teva Investigational Site 34504

    Santiago de Compostela

  • Teva Investigational Site 34508

    Valencia

  • Teva Investigational Site 34511

    Vitoria-Gasteiz

Other trials in Spain

Romania10 sites

  • Teva Investigational Site 81534

    Brasov

  • Teva Investigational Site 81539

    Brasov

  • Teva Investigational Site 81533

    Bucharest

  • Teva Investigational Site 81535

    Bucharest

  • Teva Investigational Site 81537

    Bucharest

  • Teva Investigational Site 81531

    Cluj-Napoca

  • Teva Investigational Site 81536

    Cluj-Napoca

  • Teva Investigational Site 81530

    Târgu Mureş

  • Teva Investigational Site 81532

    Timișoara

  • Teva Investigational Site 81538

    Timișoara

Other trials in Romania

Bulgaria9 sites

  • Teva Investigational Site 59507

    Burgas

  • Teva Investigational Site 59503

    Lovech

  • Teva Investigational Site 59506

    Pleven

  • Teva Investigational Site 59504

    Rousse

  • Teva Investigational Site 59501

    Sofia

  • Teva Investigational Site 59502

    Sofia

  • Teva Investigational Site 59505

    Sofia

  • Teva Investigational Site 59508

    Sofia

  • Teva Investigational Site 59509

    Varna

Other trials in Bulgaria

South Africa6 sites

  • Teva Investigational Site 36551

    Bloemfontein

  • Teva Investigational Site 36552

    Cape Town

  • Teva Investigational Site 36555

    Cape Town

  • Teva Investigational Site 36550

    Port Elizabeth

  • Teva Investigational Site 36553

    Thabazimbi

  • Teva Investigational Site 36554

    Witbank

Other trials in South Africa

Canada5 sites

  • Teva Investigational Site 11594

    Burlington, Ontario

  • Teva Investigational Site 11595

    Etobicoke, Ontario

  • Teva Investigational Site 11591

    Newmarket

  • Teva Investigational Site 11592

    Sarnia, Ontario

  • Teva Investigational Site 11590

    Toronto, Ontario

Other trials in Canada

Greece5 sites

  • Teva Investigational Site 85533

    Athens

  • Teva Investigational Site 85534

    Athens

  • Teva Investigational Site 85531

    Heraklion

  • Teva Investigational Site 85532

    Larissa

  • Teva Investigational Site 85530

    Thessaloniki

Other trials in Greece

United Kingdom5 sites

  • Teva Investigational Site 34582

    Cottingham

  • Teva Investigational Site 34584

    London

  • Teva Investigational Site 34585

    Penzance

  • Teva Investigational Site 34580

    Torpoint

  • Teva Investigational Site 34581

    Watford

Other trials in United Kingdom

Croatia4 sites

  • Teva Investigational Site 85501

    Zagreb

  • Teva Investigational Site 85502

    Zagreb

  • Teva Investigational Site 85503

    Zagreb

  • Teva Investigational Site 85504

    Zagreb

Other trials in Croatia

New Zealand4 sites

  • Teva Investigational Site 81571

    Auckland

  • Teva Investigational Site 81572

    Christchurch

  • Teva Investigational Site 81573

    Tauranga

  • Teva Investigational Site 81570

    Wellington

Other trials in New Zealand

Australia2 sites

  • Teva Investigational Site 85570

    Bedford Park

  • Teva Investigational Site 85571

    Parkville

Other trials in Australia

Ireland2 sites

  • Teva Investigational Site 59550

    Dublin

  • Teva Investigational Site 59551

    Dublin

Other trials in Ireland

Serbia1 site

  • Teva Investigational Site 81501

    Belgrade

Other trials in Serbia

About this study

Official title: A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Severe Persistent Asthma Uncontrolled on High Dose Inhaled Corticosteroid Therapy

The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.

Conditions
Asthma
Being tested
Fp MDPI, Placebo MDPI, Flovent Diskus, albuterol/salbutamol
Keywords
Dose ranging, Fluticasone Propionate, Dry Powder Inhaler (DPI), High Dose ICS, Asthma
Medical subject headings
Asthma

What participants receive

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

  • Fp MDPIDrug

    Also called fluticasone propionate, Fp SPIROMAX® Inhalation Powder

    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 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.

  • Placebo MDPIOther

    Placebo multidose dry powder inhaler (MDPI) in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.

  • Flovent DiskusDrug

    Also called Fluticasone propionate

    Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 250 mcg was used twice a day, once in the morning and evening, for a total daily dose of 500 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.

  • 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).

Study groups in NCT01576718
Study groupRoleWhat they receive
Fp MDPI 50 mcgExperimentalFluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol
Fp MDPI 100 mcgExperimentalFluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol
Fp MDPI 200 mcgExperimentalFluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol
Fp MDPI 400 mcgExperimentalFluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol
Placebo MDPIPlacebo comparatorPlacebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Receives: Other: Placebo MDPI; Drug: albuterol/salbutamol
Flovent Diskus 250mcgActive comparatorFluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Receives: Drug: Flovent Diskus; Drug: albuterol/salbutamol

What is being measured

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

  1. Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period

    Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.

    The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.

    Measured: Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Secondary outcomes (10)

  1. Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period

    Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

    On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.

    Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.

    The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.

    Measured: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

  2. Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period

    Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.

    PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.

    The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.

    Measured: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

  3. The Kaplan-Meier Estimate Of The Probability Of Remaining In The 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. Worsening asthma was defined as:

    1. clinic visit FEV1 below the FEV1 stability limit value calculated on Day 1.
    2. any 7-day run-in or treatment window (using information from the patient diary) during which the subject experienced:
    • 3 or more days in which the highest PEF has fallen below the PEF stability limit calculated on Day 1
    • 3 or more days in which ≥12 inhalations/day of albuterol/salbutamol was used
    • 2 or more days in which the subject experienced a nighttime asthma symptom score of >2
    1. clinical asthma exacerbation, defined as worsening asthma requiring any treatment other than study drug or rescue albuterol/salbutamol including the use of systemic corticosteroids and/or ER visit or hospitalization.

    Patients who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.

    Measured: Day 1 to Week 12

  4. Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods

    The change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model, with the response being the proportion of rescue-free 24-hour periods. The model included 2 time points of measurement for each subject: the baseline (the last 7 days before the treatment period) and the treatment period. The model contained covariates for sex, age, and treatment. Rescue-free days were as indicated in patient diaries.

    Data values are estimated means.

    Measured: Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)

  5. Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)

    Measured: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

  6. Maximum Observed Plasma Concentration (Cmax)

    Measured: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

  7. Time Of Maximum Observed Plasma Concentration (Tmax)

    Measured: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

  8. 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

  9. Patients With Positive Swab Test Results for Oral Candidiasis

    Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.

    This outcomes indicates how many patients had positive swab test results. The total number of patients who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol.

    Measured: Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12

  10. 24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint

    24-hour urinary cortisol excretion was determined from 24-hour pooled-urine samples; urine was refrigerated until return to the investigational site after each 24-hour collection period. Urine was collected within 7 days of Day 1 and within 7 days of Week 12. Urine cortisol sample collection was not required at endpoint visit for subjects who terminated early from the study.

    Measured: Baseline (Day 1), Week 12, Endpoint

Timeline

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

  1. First posted12 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJul 2013
  4. Study completionOct 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
889 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01576718
Sponsor's protocol ID
FpS-AS-202
Other IDs
2010-023601-35
Status last verified
May 2018
First submitted
10 Apr 2012
Last updated
8 May 2018
Data monitoring committee
No

Publications

  • Bernstein DI, Gillespie M, Song S, Steinfeld J. Safety, efficacy, and dose response of fluticasone propionate delivered via the novel MDPI in patients with severe asthma: A randomized, controlled, dose-ranging study. J Asthma. 2017 Aug;54(6):559-569. doi: 10.1080/02770903.2016.1242137. Epub 2016 Oct 24.

    PubMed 27937064

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fp MDPI, Flovent Diskus and albuterol/salbutamol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 300 sites in 19 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 36 inclusion and 28 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 300 sites in United States, Ukraine, Hungary, Germany, Israel and 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (time frame: Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12). 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 NCT01576718, which also lists 1 linked publication.

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 8 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in