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

NCT01576718 | Completed Phase 2 Results

• 2 other identifiers: FpS-AS-2022010-023601-35
• Study Type: interventional
• Target: 889
• Locations: 19 countries
• Sites: 300

Brief 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 persistent asthma who are uncontrolled on high dose ICS therapy.

Conditions

Asthma

Keywords

Dose ranging; Fluticasone Propionate; Dry Powder Inhaler (DPI); High Dose ICS; Asthma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

• 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

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

• 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

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

• The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12

  Day 1 to Week 12

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

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

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

  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

Other Outcomes (3)

• Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)

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

• 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 (Including the Flovent Diskus Treatment Arm)

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

• 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 (Including the Flovent Diskus Treatment Arm)

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

Study Arms (6)

Fp MDPI 50 mcg

EXPERIMENTAL

Fluticasone 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.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Fp MDPI 100 mcg

EXPERIMENTAL

Fluticasone 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.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Fp MDPI 200 mcg

EXPERIMENTAL

Fluticasone 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.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Fp MDPI 400 mcg

EXPERIMENTAL

Fluticasone 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.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Placebo MDPI

PLACEBO COMPARATOR

Placebo 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.

Other: Placebo MDPI; Drug: albuterol/salbutamol

Flovent Diskus 250mcg

ACTIVE COMPARATOR

Fluticasone 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.

Drug: Flovent Diskus; Drug: albuterol/salbutamol

Interventions

Fp MDPI DRUG

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to 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.

Also known as: fluticasone propionate, Fp SPIROMAX® Inhalation Powder

Fp MDPI 100 mcg; Fp MDPI 200 mcg; Fp MDPI 400 mcg; Fp MDPI 50 mcg

Placebo MDPI OTHER

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

Placebo MDPI

Flovent Diskus DRUG

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.

Also known as: Fluticasone propionate

Flovent Diskus 250mcg

albuterol/salbutamol DRUG

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).

Also known as: short-acting β2-adrenergic agonists

Flovent Diskus 250mcg; Fp MDPI 100 mcg; Fp MDPI 200 mcg; Fp MDPI 400 mcg; Fp MDPI 50 mcg; Placebo MDPI

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

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

Study Sites (300)

Teva Investigational Site 10504

Birmingham, Alabama, United States

Location

Teva Investigational Site 10565

Homewood, Alabama, United States

Location

Teva Investigational Site 11527

Goodyear, Arizona, United States

Location

Teva Investigational Site 10516

Tucson, Arizona, United States

Location

Teva Investigational Site 10573

Bakersfield, California, United States

Location

Teva Investigational Site 11518

Costa Mesa, California, United States

Location

Teva Investigational Site 10590

Fountain Valley, California, United States

Location

Teva Investigational Site 10551

Granada Hills, California, United States

Location

Teva Investigational Site 11520

Huntington Beach, California, United States

Location

Teva Investigational Site 11545

Huntington Beach, California, United States

Location

Teva Investigational Site 10547

Long Beach, California, United States

Location

Teva Investigational Site 11549

Los Angeles, California, United States

Location

Teva Investigational Site 10503

Mission Viejo, California, United States

Location

Teva Investigational Site 10536

Newport Beach, California, United States

Location

Teva Investigational Site 10540

Orange, California, United States

Location

Teva Investigational Site 11551

Orange, California, United States

Location

Teva Investigational Site 10578

Palmdale, California, United States

Location

Teva Investigational Site 10585

Redwood City, California, United States

Location

Teva Investigational Site 11538

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 11522

Roseville, California, United States

Location

Teva Investigational Site 10582

San Diego, California, United States

Location

Teva Investigational Site 11554

San Diego, California, United States

Location

Teva Investigational Site 10563

San Jose, California, United States

Location

Teva Investigational Site 11556

Santa Monica, California, United States

Location

Teva Investigational Site 10506

Stockton, California, United States

Location

Teva Investigational Site 10529

Walnut Creek, California, United States

Location

Teva Investigational Site 10545

Centennial, Colorado, United States

Location

Teva Investigational Site 10572

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10533

Denver, Colorado, United States

Location

Teva Investigational Site 11531

Denver, Colorado, United States

Location

Teva Investigational Site 11542

Denver, Colorado, United States

Location

Teva Investigational Site 11569

Wheat Ridge, Colorado, United States

Location

Teva Investigational Site 10528

Waterbury, Connecticut, United States

Location

Teva Investigational Site 10556

Boynton Beach, Florida, United States

Location

Teva Investigational Site 11513

Brandon, Florida, United States

Location

Teva Investigational Site 11507

Clearwater, Florida, United States

Location

Teva Investigational Site 11546

Fort Myers, Florida, United States

Location

Teva Investigational Site 11526

Hialeah, Florida, United States

Location

Teva Investigational Site 11525

Kissimmee, Florida, United States

Location

Teva Investigational Site 10537

Miami, Florida, United States

Location

Teva Investigational Site 10553

Miami, Florida, United States

Location

Teva Investigational Site 11508

Miami, Florida, United States

Location

Teva Investigational Site 11514

Miami, Florida, United States

Location

Teva Investigational Site 11516

Miami, Florida, United States

Location

Teva Investigational Site 11530

Miami, Florida, United States

Location

Teva Investigational Site 11570

Miami, Florida, United States

Location

Teva Investigational Site 10571

Ocala, Florida, United States

Location

Teva Investigational Site 11537

Sarasota, Florida, United States

Location

Teva Investigational Site 10593

South Miami, Florida, United States

Location

Teva Investigational Site 11555

Tallahassee, Florida, United States

Location

Teva Investigational Site 10554

Tamarac, Florida, United States

Location

Teva Investigational Site 10539

Tampa, Florida, United States

Location

Teva Investigational Site 10525

Valrico, Florida, United States

Location

Teva Investigational Site 11504

Albany, Georgia, United States

Location

Teva Investigational Site 10511

Columbus, Georgia, United States

Location

Teva Investigational Site 11510

Columbus, Georgia, United States

Location

Teva Investigational Site 11572

Columbus, Georgia, United States

Location

Teva Investigational Site 10568

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 10586

Lilburn, Georgia, United States

Location

Teva Investigational Site 11539

Savannah, Georgia, United States

Location

Teva Investigational Site 10543

Stockbridge, Georgia, United States

Location

Teva Investigational Site 11558

Indianapolis, Indiana, United States

Location

Teva Investigational Site 10527

South Bend, Indiana, United States

Location

Teva Investigational Site 10584

Iowa City, Iowa, United States

Location

Teva Investigational Site 11501

Overland Park, Kansas, United States

Location

Teva Investigational Site 10591

Lexington, Kentucky, United States

Location

Teva Investigational Site 11567

Louisville, Kentucky, United States

Location

Teva Investigational Site 10513

Metairie, Louisiana, United States

Location

Teva Investigational Site 10564

Bangor, Maine, United States

Location

Teva Investigational Site 11548

Baltimore, Maryland, United States

Location

Teva Investigational Site 10510

Largo, Maryland, United States

Location

Teva Investigational Site 10577

Wheaton, Maryland, United States

Location

Teva Investigational Site 10538

Brockton, Massachusetts, United States

Location

Teva Investigational Site 10546

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 11502

Troy, Michigan, United States

Location

Teva Investigational Site 10531

Plymouth, Minnesota, United States

Location

Teva Investigational Site 11562

Columbia, Missouri, United States

Location

Teva Investigational Site 11563

Columbia, Missouri, United States

Location

Teva Investigational Site 10552

St Louis, Missouri, United States

Location

Teva Investigational Site 10575

St Louis, Missouri, United States

Location

Teva Investigational Site 10589

St Louis, Missouri, United States

Location

Teva Investigational Site 11532

St Louis, Missouri, United States

Location

Teva Investigational Site 10518

Bellevue, Nebraska, United States

Location

Teva Investigational Site 10550

Omaha, Nebraska, United States

Location

Teva Investigational Site 11529

Omaha, Nebraska, United States

Location

Teva Investigational Site 11571

Las Vegas, Nevada, United States

Location

Teva Investigational Site 10559

Cherry Hill, New Jersey, United States

Location

Teva Investigational Site 11566

Edison, New Jersey, United States

Location

Teva Investigational Site 10501

Hillsborough, New Jersey, United States

Location

Teva Investigational Site 11550

Ocean City, New Jersey, United States

Location

Teva Investigational Site 10588

West Orange, New Jersey, United States

Location

Teva Investigational Site 11503

Albuquerque, New Mexico, United States

Location

Teva Investigational Site 10587

Brooklyn, New York, United States

Location

Teva Investigational Site 10520

New York, New York, United States

Location

Teva Investigational Site 10532

Newburgh, New York, United States

Location

Teva Investigational Site 10567

North Syracuse, New York, United States

Location

Teva Investigational Site 10512

Rochester, New York, United States

Location

Teva Investigational Site 10580

The Bronx, New York, United States

Location

Teva Investigational Site 10522

Canton, Ohio, United States

Location

Teva Investigational Site 10507

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10523

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10544

Columbus, Ohio, United States

Location

Teva Investigational Site 11521

Dayton, Ohio, United States

Location

Teva Investigational Site 11505

Middleburg Heights, Ohio, United States

Location

Teva Investigational Site 10560

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10574

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10579

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 11544

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 10598

Ashland, Oregon, United States

Location

Teva Investigational Site 11543

Medford, Oregon, United States

Location

Teva Investigational Site 11557

Portland, Oregon, United States

Location

Teva Investigational Site 10509

Altoona, Pennsylvania, United States

Location

Teva Investigational Site 10555

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 10566

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 10521

Upland, Pennsylvania, United States

Location

Teva Investigational Site 10581

Lincoln, Rhode Island, United States

Location

Teva Investigational Site 10562

Providence, Rhode Island, United States

Location

Teva Investigational Site 10526

Charleston, South Carolina, United States

Location

Teva Investigational Site 11547

Charleston, South Carolina, United States

Location

Teva Investigational Site 10583

Orangeburg, South Carolina, United States

Location

Teva Investigational Site 10517

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 11515

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 10519

Boerne, Texas, United States

Location

Teva Investigational Site 10541

Dallas, Texas, United States

Location

Teva Investigational Site 10542

Dallas, Texas, United States

Location

Teva Investigational Site 10548

El Paso, Texas, United States

Location

Teva Investigational Site 11552

El Paso, Texas, United States

Location

Teva Investigational Site 11512

Fort Worth, Texas, United States

Location

Teva Investigational Site 11565

Houston, Texas, United States

Location

Teva Investigational Site 11568

Houston, Texas, United States

Location

Teva Investigational Site 10515

San Antonio, Texas, United States

Location

Teva Investigational Site 10569

San Antonio, Texas, United States

Location

Teva Investigational Site 11517

San Antonio, Texas, United States

Location

Teva Investigational Site 11519

San Antonio, Texas, United States

Location

Teva Investigational Site 11560

Waco, Texas, United States

Location

Teva Investigational Site 11528

Layton, Utah, United States

Location

Teva Investigational Site 10576

Provo, Utah, United States

Location

Teva Investigational Site 10534

South Burlington, Vermont, United States

Location

Teva Investigational Site 10502

Fairfax, Virginia, United States

Location

Teva Investigational Site 10595

Manassas, Virginia, United States

Location

Teva Investigational Site 10508

Richmond, Virginia, United States

Location

Teva Investigational Site 11561

Bellingham, Washington, United States

Location

Teva Investigational Site 11541

Seattle, Washington, United States

Location

Teva Investigational Site 10524

Spokane, Washington, United States

Location

Teva Investigational Site 10530

Tacoma, Washington, United States

Location

Teva Investigational Site 11511

Tacoma, Washington, United States

Location

Teva Investigational Site 10570

Greenfield, Wisconsin, United States

Location

Teva Investigational Site 11559

Greenfield, Wisconsin, United States

Location

Teva Investigational Site 85570

Bedford Park, Australia

Location

Teva Investigational Site 85571

Parkville, Australia

Location

Teva Investigational Site 59507

Burgas, Bulgaria

Location

Teva Investigational Site 59503

Lovech, Bulgaria

Location

Teva Investigational Site 59506

Pleven, Bulgaria

Location

Teva Investigational Site 59504

Rousse, Bulgaria

Location

Teva Investigational Site 59501

Sofia, Bulgaria

Location

Teva Investigational Site 59502

Sofia, Bulgaria

Location

Teva Investigational Site 59505

Sofia, Bulgaria

Location

Teva Investigational Site 59508

Sofia, Bulgaria

Location

Teva Investigational Site 59509

Varna, Bulgaria

Location

Teva Investigational Site 11594

Burlington, Ontario, Canada

Location

Teva Investigational Site 11595

Etobicoke, Ontario, Canada

Location

Teva Investigational Site 11592

Sarnia, Ontario, Canada

Location

Teva Investigational Site 11590

Toronto, Ontario, Canada

Location

Teva Investigational Site 11591

Newmarket, Canada

Location

Teva Investigational Site 85501

Zagreb, Croatia

Location

Teva Investigational Site 85502

Zagreb, Croatia

Location

Teva Investigational Site 85503

Zagreb, Croatia

Location

Teva Investigational Site 85504

Zagreb, Croatia

Location

Teva Investigational Site 70561

Berlin, Germany

Location

Teva Investigational Site 70564

Bonn, Germany

Location

Teva Investigational Site 70557

Cottbus, Germany

Location

Teva Investigational Site 70553

Delitzsch, Germany

Location

Teva Investigational Site 70558

Frankfurt, Germany

Location

Teva Investigational Site 70562

Hamburg, Germany

Location

Teva Investigational Site 70560

Hanover, Germany

Location

Teva Investigational Site 70555

Leipzig, Germany

Location

Teva Investigational Site 70556

Magdeburg, Germany

Location

Teva Investigational Site 70550

München, Germany

Location

Teva Investigational Site 70554

München, Germany

Location

Teva Investigational Site 70552

Münster, Germany

Location

Teva Investigational Site 70563

Nuremberg, Germany

Location

Teva Investigational Site 70551

Rüdersdorf, Germany

Location

Teva Investigational Site 70559

Wiesbaden, Germany

Location

Teva Investigational Site 85533

Athens, Greece

Location

Teva Investigational Site 85534

Athens, Greece

Location

Teva Investigational Site 85531

Heraklion, Greece

Location

Teva Investigational Site 85532

Larissa, Greece

Location

Teva Investigational Site 85530

Thessaloniki, Greece

Location

Teva Investigational Site 36507

Balassagyarmat, Hungary

Location

Teva Investigational Site 36504

Budapest, Hungary

Location

Teva Investigational Site 36505

Budapest, Hungary

Location

Teva Investigational Site 36514

Csoma, Hungary

Location

Teva Investigational Site 36516

Érd, Hungary

Location

Teva Investigational Site 36513

Kaba, Hungary

Location

Teva Investigational Site 36515

Kaposvár, Hungary

Location

Teva Investigational Site 36503

Miskolc, Hungary

Location

Teva Investigational Site 36502

Nyíregyháza, Hungary

Location

Teva Investigational Site 36510

Siófok, Hungary

Location

Teva Investigational Site 36517

Szarvas, Hungary

Location

Teva Investigational Site 36508

Százhalombatta, Hungary

Location

Teva Investigational Site 36506

Szeged, Hungary

Location

Teva Investigational Site 36509

Szeged, Hungary

Location

Teva Investigational Site 36501

Szombathely, Hungary

Location

Teva Investigational Site 36512

Veszprém, Hungary

Location

Teva Investigational Site 59550

Dublin, Ireland

Location

Teva Investigational Site 59551

Dublin, Ireland

Location

Teva Investigational Site 72511

Ashkelon, Israel

Location

Teva Investigational Site 72501

Haifa, Israel

Location

Teva Investigational Site 72512

Haifa, Israel

Location

Teva Investigational Site 72502

Jerusalem, Israel

Location

Teva Investigational Site 72504

Jerusalem, Israel

Location

Teva Investigational Site 72509

Kfar Saba, Israel

Location

Teva Investigational Site 72506

Petah Tikva, Israel

Location

Teva Investigational Site 72507

Ramat Gan, Israel

Location

Teva Investigational Site 72503

Rehovot, Israel

Location

Teva Investigational Site 72508

Tel Aviv, Israel

Location

Teva Investigational Site 72510

Tel Aviv, Israel

Location

Teva Investigational Site 72505

Ẕerifin, Israel

Location

Teva Investigational Site 81571

Auckland, New Zealand

Location

Teva Investigational Site 81572

Christchurch, New Zealand

Location

Teva Investigational Site 81573

Tauranga, New Zealand

Location

Teva Investigational Site 81570

Wellington, New Zealand

Location

Teva Investigational Site 48507

Bialystok, Poland

Location

Teva Investigational Site 48505

Bydgoszcz, Poland

Location

Teva Investigational Site 48506

Grodzisk Mazowiecki, Poland

Location

Teva Investigational Site 48501

Lodz, Poland

Location

Teva Investigational Site 48509

Lodz, Poland

Location

Teva Investigational Site 48513

Lublin, Poland

Location

Teva Investigational Site 48508

Poznan, Poland

Location

Teva Investigational Site 48512

Poznan, Poland

Location

Teva Investigational Site 48502

Strzelce Opolskie, Poland

Location

Teva Investigational Site 48503

Tarnów, Poland

Location

Teva Investigational Site 48504

Wroclaw, Poland

Location

Teva Investigational Site 81534

Brasov, Romania

Location

Teva Investigational Site 81539

Brasov, Romania

Location

Teva Investigational Site 81533

Bucharest, Romania

Location

Teva Investigational Site 81535

Bucharest, Romania

Location

Teva Investigational Site 81537

Bucharest, Romania

Location

Teva Investigational Site 81531

Cluj-Napoca, Romania

Location

Teva Investigational Site 81536

Cluj-Napoca, Romania

Location

Teva Investigational Site 81530

Târgu Mureş, Romania

Location

Teva Investigational Site 81532

Timișoara, Romania

Location

Teva Investigational Site 81538

Timișoara, Romania

Location

Teva Investigational Site 70505

Barnaul, Russia

Location

Teva Investigational Site 70502

Kazan', Russia

Location

Teva Investigational Site 70511

Moscow, Russia

Location

Teva Investigational Site 70512

Moscow, Russia

Location

Teva Investigational Site 70508

Ryazan, Russia

Location

Teva Investigational Site 70501

Saint Petersburg, Russia

Location

Teva Investigational Site 70504

Saint Petersburg, Russia

Location

Teva Investigational Site 70510

Saint Petersburg, Russia

Location

Teva Investigational Site 70509

Samara, Russia

Location

Teva Investigational Site 70507

Smolensk, Russia

Location

Teva Investigational Site 70506

Tomsk, Russia

Location

Teva Investigational Site 70503

Yaroslavl, Russia

Location

Teva Investigational Site 81501

Belgrade, Serbia

Location

Teva Investigational Site 36551

Bloemfontein, South Africa

Location

Teva Investigational Site 36552

Cape Town, South Africa

Location

Teva Investigational Site 36555

Cape Town, South Africa

Location

Teva Investigational Site 36550

Port Elizabeth, South Africa

Location

Teva Investigational Site 36553

Thabazimbi, South Africa

Location

Teva Investigational Site 36554

Witbank, South Africa

Location

Teva Investigational Site 34507

Aranjuez, Spain

Location

Teva Investigational Site 34501

Badalona, Spain

Location

Teva Investigational Site 34502

Barcelona, Spain

Location

Teva Investigational Site 34510

Barcelona, Spain

Location

Teva Investigational Site 34509

Bilbao, Spain

Location

Teva Investigational Site 34506

Lleida, Spain

Location

Teva Investigational Site 34505

Madrid, Spain

Location

Teva Investigational Site 34503

Salt, Spain

Location

Teva Investigational Site 34504

Santiago de Compostela, Spain

Location

Teva Investigational Site 34508

Valencia, Spain

Location

Teva Investigational Site 34511

Vitoria-Gasteiz, Spain

Location

Teva Investigational Site 80501

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 80513

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 80511

Donetsk, Ukraine

Location

Teva Investigational Site 80502

Kharkiv, Ukraine

Location

Teva Investigational Site 80503

Kharkiv, Ukraine

Location

Teva Investigational Site 80504

Kyiv, Ukraine

Location

Teva Investigational Site 80505

Kyiv, Ukraine

Location

Teva Investigational Site 80506

Kyiv, Ukraine

Location

Teva Investigational Site 80507

Kyiv, Ukraine

Location

Teva Investigational Site 80508

Kyiv, Ukraine

Location

Teva Investigational Site 80509

Kyiv, Ukraine

Location

Teva Investigational Site 80517

Kyiv, Ukraine

Location

Teva Investigational Site 80519

Kyiv, Ukraine

Location

Teva Investigational Site 80520

Kyiv, Ukraine

Location

Teva Investigational Site 80521

Kyiv, Ukraine

Location

Teva Investigational Site 80514

Odesa, Ukraine

Location

Teva Investigational Site 80516

Simferopol, Ukraine

Location

Teva Investigational Site 80512

Vinnytsia, Ukraine

Location

Teva Investigational Site 80515

Yalta, Ukraine

Location

Teva Investigational Site 80522

Zaporizhia, Ukraine

Location

Teva Investigational Site 80510

Zaporizhzhia, Ukraine

Location

Teva Investigational Site 80518

Zaporizhzhya, Ukraine

Location

Teva Investigational Site 34582

Cottingham, United Kingdom

Location

Teva Investigational Site 34584

London, United Kingdom

Location

Teva Investigational Site 34585

Penzance, United Kingdom

Location

Teva Investigational Site 34580

Torpoint, United Kingdom

Location

Teva Investigational Site 34581

Watford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27937064 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

ustevatrials@tevapharm.com

215-591-3000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 8, 2018
• Results First Posted: April 12, 2017

Record last verified: 2018-05

Locations

ZA (6); CA (5); NZ (4); SE (1); ES (11); HU (16); RU (12); IL (12); GB (5); UA (22); BU (9); AU (2); DE (15); US (148); IE (2); PL (11); RO (10); GR (5); CR (4)