AzTrials
AzTrials

AsthmaPhase 2NCT01479621

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

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 189 sites in 9 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

This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. 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
909 participants
Where
189 sitesin 9 countries
Study dates
Jan 2012to Jul 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.
  • Reversibility of Disease: Demonstrated a ≥15% 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 ≥15%, then the subject is not eligible for the study and will not be allowed to re-screen.
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  • Current Asthma Therapy: Subjects must be on a short-acting β2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting β2-agonist) for ≥ 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.
  • Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects on low dose ICS (100mcg Fp BID or equivalent) may be switched to a short-acting β2 agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.
  • 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 its 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 beta 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 > 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 > or = 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 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 prior to 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 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months 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 non-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 non-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.
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  • 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.
  • Clinical visual evidence of oral candidiasis at the Screening Visit.
  • History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or 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 12 weeks prior to the Screening Visit
  • Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted
  • Use of intranasal 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 at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted.
  • Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit.
  • 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

189 sites in 9 countries.

189 sites in 9 countries

United States129 sites

  • Teva Investigational Site 11114

    Albany, Georgia

  • Teva Investigational Site 11113

    Albuquerque, New Mexico

  • Teva Investigational Site 11108

    Ashland, Oregon

  • Teva Investigational Site 10173

    Bakersfield, California

  • Teva Investigational Site 10164

    Bangor, Maine

  • Teva Investigational Site 10118

    Bellevue, Nebraska

  • Teva Investigational Site 10158

    Bethesda, Maryland

  • Teva Investigational Site 10119

    Boerne, Texas

  • Teva Investigational Site 10191

    Boynton Beach, Florida

  • Teva Investigational Site 11127

    Brandon, Florida

  • Teva Investigational Site 10114

    Brick, New Jersey

  • Teva Investigational Site 10187

    Brooklyn, New York

  • Teva Investigational Site 10159

    Burke, Virginia

  • Teva Investigational Site 10194

    Canton, Ohio

  • Teva Investigational Site 10145

    Centennial, Colorado

  • Teva Investigational Site 10126

    Charleston, South Carolina

  • Teva Investigational Site 10149

    Charleston, South Carolina

  • Teva Investigational Site 10193

    Cherry Hill, New Jersey

  • Teva Investigational Site 10107

    Cincinnati, Ohio

  • Teva Investigational Site 10123

    Cincinnati, Ohio

  • Teva Investigational Site 11118

    Clearwater, Florida

  • Teva Investigational Site 10172

    Colorado Springs, Colorado

  • Teva Investigational Site 10111

    Columbus, Georgia

  • Teva Investigational Site 11124

    Columbus, Georgia

  • Teva Investigational Site 10144

    Columbus, Ohio

  • Teva Investigational Site 10163

    Costa Mesa, California

  • Teva Investigational Site 10141

    Dallas, Texas

  • Teva Investigational Site 10192

    Dallas, Texas

  • Teva Investigational Site 11135

    Dayton, Ohio

  • Teva Investigational Site 10133

    Denver, Colorado

  • Teva Investigational Site 10154

    Denver, Colorado

  • Teva Investigational Site 11146

    Denver, Colorado

  • Teva Investigational Site 11119

    East Providence, Rhode Island

  • Teva Investigational Site 10148

    El Paso, Texas

  • Teva Investigational Site 10156

    Encinitas, California

  • Teva Investigational Site 10132

    Eugene, Oregon

  • Teva Investigational Site 10102

    Fairfax, Virginia

  • Teva Investigational Site 11101

    Fountain Valley, California

  • Teva Investigational Site 11111

    Fresno, California

  • Teva Investigational Site 10180

    Gainesville, Georgia

  • Teva Investigational Site 11142

    Goodyear, Arizona

  • Teva Investigational Site 10151

    Granada Hills, California

  • Teva Investigational Site 10170

    Greenfield, Wisconsin

  • Teva Investigational Site 11136

    Henderson, Nevada

  • Teva Investigational Site 11141

    Hialeah, Florida

  • Teva Investigational Site 10105

    High Point, North Carolina

  • Teva Investigational Site 10101

    Hillsborough, New Jersey

  • Teva Investigational Site 10165

    Homewood, Alabama

  • Teva Investigational Site 10157

    Huntington Beach, California

  • Teva Investigational Site 10176

    Huntington Beach, California

  • Teva Investigational Site 11109

    Idaho Falls, Idaho

  • Teva Investigational Site 10184

    Iowa City, Iowa

  • Teva Investigational Site 11140

    Kissimmee, Florida

  • Teva Investigational Site 10110

    Largo, Maryland

  • Teva Investigational Site 10168

    Lawrenceville, Georgia

  • Teva Investigational Site 11143

    Layton, Utah

  • Teva Investigational Site 10181

    Lincoln, Rhode Island

  • Teva Investigational Site 11149

    Little Rock, Arkansas

  • Teva Investigational Site 10147

    Long Beach, California

  • Teva Investigational Site 11105

    Manassas, Virginia

  • Teva Investigational Site 10135

    Medford, Oregon

  • Teva Investigational Site 10116

    Meridian, Idaho

  • Teva Investigational Site 10113

    Metairie, Louisiana

  • Teva Investigational Site 10137

    Miami, Florida

  • Teva Investigational Site 10153

    Miami, Florida

  • Teva Investigational Site 11120

    Miami, Florida

  • Teva Investigational Site 11128

    Miami, Florida

  • Teva Investigational Site 11132

    Miami, Florida

  • Teva Investigational Site 11145

    Miami, Florida

  • Teva Investigational Site 11115

    Middleburg Heights, Ohio

  • Teva Investigational Site 10131

    Minneapolis, Minnesota

  • Teva Investigational Site 11110

    Napa, California

  • Teva Investigational Site 10120

    New York, New York

  • Teva Investigational Site 10190

    Newburgh, New York

  • Teva Investigational Site 10136

    Newport Beach, California

  • Teva Investigational Site 11104

    Normal Square, Pennsylvania

  • Teva Investigational Site 10138

    North Dartmouth, Massachusetts

  • Teva Investigational Site 10146

    North Dartmouth, Massachusetts

  • Teva Investigational Site 11122

    North Hollywood, California

  • Teva Investigational Site 10167

    North Syracuse, New York

  • Teva Investigational Site 10171

    Ocala, Florida

  • Teva Investigational Site 10160

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10174

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10198

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10150

    Omaha, Nebraska

  • Teva Investigational Site 11144

    Omaha, Nebraska

  • Teva Investigational Site 10140

    Orange, California

  • Teva Investigational Site 10199

    Orangeburg, South Carolina

  • Teva Investigational Site 10197

    Palmdale, California

  • Teva Investigational Site 10183

    Philadelphia, Pennsylvania

  • Teva Investigational Site 10166

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 10142

    Portland, Oregon

  • Teva Investigational Site 10162

    Providence, Rhode Island

  • Teva Investigational Site 10195

    Provo, Utah

  • Teva Investigational Site 10122

    Raleigh, North Carolina

  • Teva Investigational Site 10185

    Redwood City, California

  • Teva Investigational Site 10108

    Richmond, Virginia

  • Teva Investigational Site 10143

    Riverside, California

  • Teva Investigational Site 10112

    Rochester, New York

  • Teva Investigational Site 11137

    Roseville, California

  • Teva Investigational Site 10115

    San Antonio, Texas

  • Teva Investigational Site 11133

    San Antonio, Texas

  • Teva Investigational Site 11134

    San Antonio, Texas

  • Teva Investigational Site 10130

    San Diego, California

  • Teva Investigational Site 10182

    San Diego, California

  • Teva Investigational Site 10179

    San Jose, California

  • Teva Investigational Site 10178

    Sarasota, Florida

  • Teva Investigational Site 10104

    Scottsdale, Arizona

  • Teva Investigational Site 10155

    Skillman, New Jersey

  • Teva Investigational Site 10127

    South Bend, Indiana

  • Teva Investigational Site 10134

    South Burlington, Vermont

  • Teva Investigational Site 11103

    South Miami, Florida

  • Teva Investigational Site 11131

    Spartanburg, South Carolina

  • Teva Investigational Site 10124

    Spokane, Washington

  • Teva Investigational Site 10175

    St Louis, Missouri

  • Teva Investigational Site 10189

    St Louis, Missouri

  • Teva Investigational Site 11147

    St Louis, Missouri

  • Teva Investigational Site 10106

    Stockton, California

  • Teva Investigational Site 11117

    Tacoma, Washington

  • Teva Investigational Site 11125

    Tacoma, Washington

  • Teva Investigational Site 10161

    Tallahassee, Florida

  • Teva Investigational Site 10139

    Tampa, Florida

  • Teva Investigational Site 10121

    Upland, Pennsylvania

  • Teva Investigational Site 10103

    Waco, Texas

  • Teva Investigational Site 10129

    Walnut Creek, California

  • Teva Investigational Site 10196

    Waterbury, Connecticut

  • Teva Investigational Site 10188

    West Orange, New Jersey

  • Teva Investigational Site 10128

    Wheat Ridge, Colorado

  • Teva Investigational Site 10177

    Wheaton, Maryland

Other trials in United States

Ukraine16 sites

  • Teva Investigational Site 80101

    Dnipropetrovsk

  • Teva Investigational Site 80113

    Dnipropetrovsk

  • Teva Investigational Site 80111

    Donetsk

  • Teva Investigational Site 80103

    Kharkiv

  • Teva Investigational Site 80117

    Kharkiv

  • Teva Investigational Site 80104

    Kyiv

  • Teva Investigational Site 80105

    Kyiv

  • Teva Investigational Site 80106

    Kyiv

  • Teva Investigational Site 80107

    Kyiv

  • Teva Investigational Site 80108

    Kyiv

  • Teva Investigational Site 80109

    Kyiv

  • Teva Investigational Site 80114

    Odesa

  • Teva Investigational Site 80118

    Ternopil

  • Teva Investigational Site 80112

    Vinnytsia

  • Teva Investigational Site 80115

    Yalta

  • Teva Investigational Site 80110

    Zaporizhzhya

Other trials in Ukraine

Hungary11 sites

  • Teva Investigational Site 36107

    Balassagyarmat

  • Teva Investigational Site 36104

    Budapest

  • Teva Investigational Site 36105

    Budapest

  • Teva Investigational Site 36113

    Csoma

  • Teva Investigational Site 36103

    Miskolc

  • Teva Investigational Site 36108

    Mosdós

  • Teva Investigational Site 36102

    Nyíregyháza

  • Teva Investigational Site 36106

    Szeged

  • Teva Investigational Site 36109

    Szeged

  • Teva Investigational Site 36101

    Szombathely

  • Teva Investigational Site 36111

    Tatabánya

Other trials in Hungary

Israel10 sites

  • Teva Investigational Site 72111

    Ashkelon

  • Teva Investigational Site 72101

    Haifa

  • Teva Investigational Site 72102

    Jerusalem

  • Teva Investigational Site 72104

    Jerusalem

  • Teva Investigational Site 72109

    Kfar Saba

  • Teva Investigational Site 72106

    Petah Tikva

  • Teva Investigational Site 72107

    Ramat Gan

  • Teva Investigational Site 72103

    Rehovot

  • Teva Investigational Site 72108

    Tel Aviv

  • Teva Investigational Site 72110

    Tel Aviv

Other trials in Israel

Bulgaria7 sites

  • Teva Investigational Site 59107

    Burgas

  • Teva Investigational Site 59103

    Lovech

  • Teva Investigational Site 59106

    Pleven

  • Teva Investigational Site 59104

    Rousse

  • Teva Investigational Site 59101

    Sofia

  • Teva Investigational Site 59102

    Sofia

  • Teva Investigational Site 59105

    Sofia

Other trials in Bulgaria

Poland7 sites

  • Teva Investigational Site 48107

    Bialystok

  • Teva Investigational Site 48105

    Bydgoszcz

  • Teva Investigational Site 48106

    Grodzisk Mazowiecki

  • Teva Investigational Site 48101

    Lodz

  • Teva Investigational Site 48108

    Poznan

  • Teva Investigational Site 48103

    Tarnów

  • Teva Investigational Site 48104

    Wroclaw

Other trials in Poland

Croatia4 sites

  • Teva Investigational Site 85105

    Split

  • Teva Investigational Site 85102

    Zagreb

  • Teva Investigational Site 85103

    Zagreb

  • Teva Investigational Site 85104

    Zagreb

Other trials in Croatia

Spain3 sites

  • Teva Investigational Site 34101

    Badalona

  • Teva Investigational Site 34102

    Barcelona

  • Teva Investigational Site 34103

    Salt

Other trials in Spain

Serbia2 sites

  • Teva Investigational Site 81101

    Belgrade

  • Teva Investigational Site 81102

    Belgrade

Other trials in Serbia

About this study

Official title: A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fluticasone Propionate DPI Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Persistent Asthma Uncontrolled on Non-steroidal Therapy

This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.

Conditions
Asthma
Being tested
Fp MDPI, Flovent Diskus, albuterol/salbutamol, Placebo MDPI
Keywords
Dose Ranging, Fluticasone Propionate, Dry Powder Inhaler (DPI), Non-steroidal, 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 12.5, 25, 50 or 100 mcg of Fp one inhalation twice a day for a total daily dose of 25, 50, 100 or 200 mcg. Study drug was administered in the morning and in the evening

  • Flovent DiskusDrug

    Also called Fluticasone propionate

    Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose of 200 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).

  • Placebo MDPIDrug

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

Study groups in NCT01479621
Study groupRoleWhat they receive
Fp MDPI 12.5 mcgExperimentalFluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcgExperimentalFluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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 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
Placebo MDPIExperimentalPlacebo 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: Drug: albuterol/salbutamol; Drug: Placebo MDPI
Flovent Diskus 100mcgExperimentalFluticasone 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 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), During Study (Days 7, 14, 28, 56 and 84 pre-dose)

Secondary outcomes (9)

  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 -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

  2. Change From Baseline In Weekly Average Of Daily 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 -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

  3. Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period

    The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device.

    Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject.

    Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean.

    Measured: Baseline (Days -7 to -1), During Study (Days 1-84)

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

    The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.

    Measured: Day 1 to Day 84

  5. Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp

    Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.

    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) of Fp

    Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.

    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 Concentration (Tmax) of Fp

    Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.

    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 -84

  9. Oropharyngeal Exam Findings at Each Study Visit

    Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. 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. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study.

    Data format: Time frame, <signs of oral candidiasis?> yes or no

    Measured: Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12

Timeline

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

  1. First posted24 Nov 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2013
  4. Study completionJul 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
909 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479621
Sponsor's protocol ID
FpS-AS-201
Other IDs
2010-023600-27
Status last verified
May 2017
First submitted
22 Nov 2011
Last updated
5 Jun 2017
Data monitoring committee
No

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 189 sites in 9 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 21 inclusion and 27 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Ukraine, Hungary, Israel, Bulgaria and 4 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. 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), During Study (Days 7, 14, 28, 56 and 84 pre-dose)). 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 NCT01479621.

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 5 Jun 2017.

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