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

NCT ID: NCT01576718

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 889 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fp MDPI 50 mcg

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.

Group Type: EXPERIMENTAL

Fp MDPI

Intervention Type: 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.

albuterol/salbutamol

Intervention Type: 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).

Fp MDPI 100 mcg

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.

Group Type: EXPERIMENTAL

Fp MDPI

Intervention Type: 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.

albuterol/salbutamol

Intervention Type: 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).

Fp MDPI 200 mcg

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.

Group Type: EXPERIMENTAL

Fp MDPI

Intervention Type: 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.

albuterol/salbutamol

Intervention Type: 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).

Fp MDPI 400 mcg

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.

Group Type: EXPERIMENTAL

Fp MDPI

Intervention Type: 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.

albuterol/salbutamol

Intervention Type: 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).

Placebo MDPI

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.

Group Type: PLACEBO_COMPARATOR

Placebo MDPI

Intervention Type: OTHER

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

albuterol/salbutamol

Intervention Type: 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).

Flovent Diskus 250mcg

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.

Group Type: ACTIVE_COMPARATOR

Flovent Diskus

Intervention Type: 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.

albuterol/salbutamol

Intervention Type: 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).

Interventions

Fp MDPI

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.

Intervention Type: DRUG

Placebo MDPI

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

Intervention Type: OTHER

Flovent Diskus

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.

Intervention Type: DRUG

albuterol/salbutamol

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).

Intervention Type: DRUG

Other Intervention Names

fluticasone propionate; Fp SPIROMAX® Inhalation Powder; Fluticasone propionate; short-acting β2-adrenergic agonists

Eligibility Criteria

Inclusion Criteria

1. Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.

2. 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.

3. 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.

4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).

5. 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

6. 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.

7. 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.

8. 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.

9. 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

10. 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).

Exclusion Criteria

1. 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.

2. 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.

3. 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.

4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.

5. 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.

6. 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

7. History of a positive test for HIV, hepatitis B or hepatitis C infection.

8. 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

9. 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).

10. History of severe allergy to milk protein.

11. 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

12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.

13. 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.

14. 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.

15. History of alcohol or drug abuse within two years preceding the Screening Visit.

16. 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).

17. Study participation by clinical investigator site employees and/or their immediate relatives.

18. 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.

19. 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.

20. 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 10504

Birmingham, Alabama, United States

Teva Investigational Site 10565

Homewood, Alabama, United States

Teva Investigational Site 11527

Goodyear, Arizona, United States

Teva Investigational Site 10516

Tucson, Arizona, United States

Teva Investigational Site 10573

Bakersfield, California, United States

Teva Investigational Site 11518

Costa Mesa, California, United States

Teva Investigational Site 10590

Fountain Valley, California, United States

Teva Investigational Site 10551

Granada Hills, California, United States

Teva Investigational Site 11520

Huntington Beach, California, United States

Teva Investigational Site 11545

Huntington Beach, California, United States

Teva Investigational Site 10547

Long Beach, California, United States

Teva Investigational Site 11549

Los Angeles, California, United States

Teva Investigational Site 10503

Mission Viejo, California, United States

Teva Investigational Site 10536

Newport Beach, California, United States

Teva Investigational Site 10540

Orange, California, United States

Teva Investigational Site 11551

Orange, California, United States

Teva Investigational Site 10578

Palmdale, California, United States

Teva Investigational Site 10585

Redwood City, California, United States

Teva Investigational Site 11538

Rolling Hills Estates, California, United States

Teva Investigational Site 11522

Roseville, California, United States

Teva Investigational Site 10582

San Diego, California, United States

Teva Investigational Site 11554

San Diego, California, United States

Teva Investigational Site 10563

San Jose, California, United States

Teva Investigational Site 11556

Santa Monica, California, United States

Teva Investigational Site 10506

Stockton, California, United States

Teva Investigational Site 10529

Walnut Creek, California, United States

Teva Investigational Site 10545

Centennial, Colorado, United States

Teva Investigational Site 10572

Colorado Springs, Colorado, United States

Teva Investigational Site 10533

Denver, Colorado, United States

Teva Investigational Site 11531

Denver, Colorado, United States

Teva Investigational Site 11542

Denver, Colorado, United States

Teva Investigational Site 11569

Wheat Ridge, Colorado, United States

Teva Investigational Site 10528

Waterbury, Connecticut, United States

Teva Investigational Site 10556

Boynton Beach, Florida, United States

Teva Investigational Site 11513

Brandon, Florida, United States

Teva Investigational Site 11507

Clearwater, Florida, United States

Teva Investigational Site 11546

Fort Myers, Florida, United States

Teva Investigational Site 11526

Hialeah, Florida, United States

Teva Investigational Site 11525

Kissimmee, Florida, United States

Teva Investigational Site 10537

Miami, Florida, United States

Teva Investigational Site 10553

Miami, Florida, United States

Teva Investigational Site 11508

Miami, Florida, United States

Teva Investigational Site 11514

Miami, Florida, United States

Teva Investigational Site 11516

Miami, Florida, United States

Teva Investigational Site 11530

Miami, Florida, United States

Teva Investigational Site 11570

Miami, Florida, United States

Teva Investigational Site 10571

Ocala, Florida, United States

Teva Investigational Site 11537

Sarasota, Florida, United States

Teva Investigational Site 10593

South Miami, Florida, United States

Teva Investigational Site 11555

Tallahassee, Florida, United States

Teva Investigational Site 10554

Tamarac, Florida, United States

Teva Investigational Site 10539

Tampa, Florida, United States

Teva Investigational Site 10525

Valrico, Florida, United States

Teva Investigational Site 11504

Albany, Georgia, United States

Teva Investigational Site 10511

Columbus, Georgia, United States

Teva Investigational Site 11510

Columbus, Georgia, United States

Teva Investigational Site 11572

Columbus, Georgia, United States

Teva Investigational Site 10568

Lawrenceville, Georgia, United States

Teva Investigational Site 10586

Lilburn, Georgia, United States

Teva Investigational Site 11539

Savannah, Georgia, United States

Teva Investigational Site 10543

Stockbridge, Georgia, United States

Teva Investigational Site 11558

Indianapolis, Indiana, United States

Teva Investigational Site 10527

South Bend, Indiana, United States

Teva Investigational Site 10584

Iowa City, Iowa, United States

Teva Investigational Site 11501

Overland Park, Kansas, United States

Teva Investigational Site 10591

Lexington, Kentucky, United States

Teva Investigational Site 11567

Louisville, Kentucky, United States

Teva Investigational Site 10513

Metairie, Louisiana, United States

Teva Investigational Site 10564

Bangor, Maine, United States

Teva Investigational Site 11548

Baltimore, Maryland, United States

Teva Investigational Site 10510

Largo, Maryland, United States

Teva Investigational Site 10577

Wheaton, Maryland, United States

Teva Investigational Site 10538

Brockton, Massachusetts, United States

Teva Investigational Site 10546

North Dartmouth, Massachusetts, United States

Teva Investigational Site 11502

Troy, Michigan, United States

Teva Investigational Site 10531

Plymouth, Minnesota, United States

Teva Investigational Site 11562

Columbia, Missouri, United States

Teva Investigational Site 11563

Columbia, Missouri, United States

Teva Investigational Site 10552

St Louis, Missouri, United States

Teva Investigational Site 10575

St Louis, Missouri, United States

Teva Investigational Site 10589

St Louis, Missouri, United States

Teva Investigational Site 11532

St Louis, Missouri, United States

Teva Investigational Site 10518

Bellevue, Nebraska, United States

Teva Investigational Site 10550

Omaha, Nebraska, United States

Teva Investigational Site 11529

Omaha, Nebraska, United States

Teva Investigational Site 11571

Las Vegas, Nevada, United States

Teva Investigational Site 10559

Cherry Hill, New Jersey, United States

Teva Investigational Site 11566

Edison, New Jersey, United States

Teva Investigational Site 10501

Hillsborough, New Jersey, United States

Teva Investigational Site 11550

Ocean City, New Jersey, United States

Teva Investigational Site 10588

West Orange, New Jersey, United States

Teva Investigational Site 11503

Albuquerque, New Mexico, United States

Teva Investigational Site 10587

Brooklyn, New York, United States

Teva Investigational Site 10520

New York, New York, United States

Teva Investigational Site 10532

Newburgh, New York, United States

Teva Investigational Site 10567

North Syracuse, New York, United States

Teva Investigational Site 10512

Rochester, New York, United States

Teva Investigational Site 10580

The Bronx, New York, United States

Teva Investigational Site 10522

Canton, Ohio, United States

Teva Investigational Site 10507

Cincinnati, Ohio, United States

Teva Investigational Site 10523

Cincinnati, Ohio, United States

Teva Investigational Site 10544

Columbus, Ohio, United States

Teva Investigational Site 11521

Dayton, Ohio, United States

Teva Investigational Site 11505

Middleburg Heights, Ohio, United States

Teva Investigational Site 10560

Oklahoma City, Oklahoma, United States

Teva Investigational Site 10574

Oklahoma City, Oklahoma, United States

Teva Investigational Site 10579

Oklahoma City, Oklahoma, United States

Teva Investigational Site 11544

Tulsa, Oklahoma, United States

Teva Investigational Site 10598

Ashland, Oregon, United States

Teva Investigational Site 11543

Medford, Oregon, United States

Teva Investigational Site 11557

Portland, Oregon, United States

Teva Investigational Site 10509

Altoona, Pennsylvania, United States

Teva Investigational Site 10555

Philadelphia, Pennsylvania, United States

Teva Investigational Site 10566

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 10521

Upland, Pennsylvania, United States

Teva Investigational Site 10581

Lincoln, Rhode Island, United States

Teva Investigational Site 10562

Providence, Rhode Island, United States

Teva Investigational Site 10526

Charleston, South Carolina, United States

Teva Investigational Site 11547

Charleston, South Carolina, United States

Teva Investigational Site 10583

Orangeburg, South Carolina, United States

Teva Investigational Site 10517

Spartanburg, South Carolina, United States

Teva Investigational Site 11515

Spartanburg, South Carolina, United States

Teva Investigational Site 10519

Boerne, Texas, United States

Teva Investigational Site 10541

Dallas, Texas, United States

Teva Investigational Site 10542

Dallas, Texas, United States

Teva Investigational Site 10548

El Paso, Texas, United States

Teva Investigational Site 11552

El Paso, Texas, United States

Teva Investigational Site 11512

Fort Worth, Texas, United States

Teva Investigational Site 11565

Houston, Texas, United States

Teva Investigational Site 11568

Houston, Texas, United States

Teva Investigational Site 10515

San Antonio, Texas, United States

Teva Investigational Site 10569

San Antonio, Texas, United States

Teva Investigational Site 11517

San Antonio, Texas, United States

Teva Investigational Site 11519

San Antonio, Texas, United States

Teva Investigational Site 11560

Waco, Texas, United States

Teva Investigational Site 11528

Layton, Utah, United States

Teva Investigational Site 10576

Provo, Utah, United States

Teva Investigational Site 10534

South Burlington, Vermont, United States

Teva Investigational Site 10502

Fairfax, Virginia, United States

Teva Investigational Site 10595

Manassas, Virginia, United States

Teva Investigational Site 10508

Richmond, Virginia, United States

Teva Investigational Site 11561

Bellingham, Washington, United States

Teva Investigational Site 11541

Seattle, Washington, United States

Teva Investigational Site 10524

Spokane, Washington, United States

Teva Investigational Site 10530

Tacoma, Washington, United States

Teva Investigational Site 11511

Tacoma, Washington, United States

Teva Investigational Site 10570

Greenfield, Wisconsin, United States

Teva Investigational Site 11559

Greenfield, Wisconsin, United States

Teva Investigational Site 85570

Bedford Park, , Australia

Teva Investigational Site 85571

Parkville, , Australia

Teva Investigational Site 59507

Burgas, , Bulgaria

Teva Investigational Site 59503

Lovech, , Bulgaria

Teva Investigational Site 59506

Pleven, , Bulgaria

Teva Investigational Site 59504

Rousse, , Bulgaria

Teva Investigational Site 59501

Sofia, , Bulgaria

Teva Investigational Site 59502

Sofia, , Bulgaria

Teva Investigational Site 59505

Sofia, , Bulgaria

Teva Investigational Site 59508

Sofia, , Bulgaria

Teva Investigational Site 59509

Varna, , Bulgaria

Teva Investigational Site 11594

Burlington, Ontario, Canada

Teva Investigational Site 11595

Etobicoke, Ontario, Canada

Teva Investigational Site 11592

Sarnia, Ontario, Canada

Teva Investigational Site 11590

Toronto, Ontario, Canada

Teva Investigational Site 11591

Newmarket, , Canada

Teva Investigational Site 85501

Zagreb, , Croatia

Teva Investigational Site 85502

Zagreb, , Croatia

Teva Investigational Site 85503

Zagreb, , Croatia

Teva Investigational Site 85504

Zagreb, , Croatia

Teva Investigational Site 70561

Berlin, , Germany

Teva Investigational Site 70564

Bonn, , Germany

Teva Investigational Site 70557

Cottbus, , Germany

Teva Investigational Site 70553

Delitzsch, , Germany

Teva Investigational Site 70558

Frankfurt, , Germany

Teva Investigational Site 70562

Hamburg, , Germany

Teva Investigational Site 70560

Hanover, , Germany

Teva Investigational Site 70555

Leipzig, , Germany

Teva Investigational Site 70556

Magdeburg, , Germany

Teva Investigational Site 70550

München, , Germany

Teva Investigational Site 70554

München, , Germany

Teva Investigational Site 70552

Münster, , Germany

Teva Investigational Site 70563

Nuremberg, , Germany

Teva Investigational Site 70551

Rudersdorf, , Germany

Teva Investigational Site 70559

Wiesbaden, , Germany

Teva Investigational Site 85533

Athens, , Greece

Teva Investigational Site 85534

Athens, , Greece

Teva Investigational Site 85531

Heraklion, , Greece

Teva Investigational Site 85532

Larissa, , Greece

Teva Investigational Site 85530

Thessaloniki, , Greece

Teva Investigational Site 36507

Balassagyarmat, , Hungary

Teva Investigational Site 36504

Budapest, , Hungary

Teva Investigational Site 36505

Budapest, , Hungary

Teva Investigational Site 36514

Csoma, , Hungary

Teva Investigational Site 36516

Érd, , Hungary

Teva Investigational Site 36513

Kaba, , Hungary

Teva Investigational Site 36515

Kaposvár, , Hungary

Teva Investigational Site 36503

Miskolc, , Hungary

Teva Investigational Site 36502

Nyíregyháza, , Hungary

Teva Investigational Site 36510

Siófok, , Hungary

Teva Investigational Site 36517

Szarvas, , Hungary

Teva Investigational Site 36508

Százhalombatta, , Hungary

Teva Investigational Site 36506

Szeged, , Hungary

Teva Investigational Site 36509

Szeged, , Hungary

Teva Investigational Site 36501

Szombathely, , Hungary

Teva Investigational Site 36512

Veszprém, , Hungary

Teva Investigational Site 59550

Dublin, , Ireland

Teva Investigational Site 59551

Dublin, , Ireland

Teva Investigational Site 72511

Ashkelon, , Israel

Teva Investigational Site 72501

Haifa, , Israel

Teva Investigational Site 72512

Haifa, , Israel

Teva Investigational Site 72502

Jerusalem, , Israel

Teva Investigational Site 72504

Jerusalem, , Israel

Teva Investigational Site 72509

Kfar Saba, , Israel

Teva Investigational Site 72506

Petah Tikva, , Israel

Teva Investigational Site 72507

Ramat Gan, , Israel

Teva Investigational Site 72503

Rehovot, , Israel

Teva Investigational Site 72508

Tel Aviv, , Israel

Teva Investigational Site 72510

Tel Aviv, , Israel

Teva Investigational Site 72505

Ẕerifin, , Israel

Teva Investigational Site 81571

Auckland, , New Zealand

Teva Investigational Site 81572

Christchurch, , New Zealand

Teva Investigational Site 81573

Tauranga, , New Zealand

Teva Investigational Site 81570

Wellington, , New Zealand

Teva Investigational Site 48507

Bialystok, , Poland

Teva Investigational Site 48505

Bydgoszcz, , Poland

Teva Investigational Site 48506

Grodzisk Mazowiecki, , Poland

Teva Investigational Site 48501

Lodz, , Poland

Teva Investigational Site 48509

Lodz, , Poland

Teva Investigational Site 48513

Lublin, , Poland

Teva Investigational Site 48508

Poznan, , Poland

Teva Investigational Site 48512

Poznan, , Poland

Teva Investigational Site 48502

Strzelce Opolskie, , Poland

Teva Investigational Site 48503

Tarnów, , Poland

Teva Investigational Site 48504

Wroclaw, , Poland

Teva Investigational Site 81534

Brasov, , Romania

Teva Investigational Site 81539

Brasov, , Romania

Teva Investigational Site 81533

Bucharest, , Romania

Teva Investigational Site 81535

Bucharest, , Romania

Teva Investigational Site 81537

Bucharest, , Romania

Teva Investigational Site 81531

Cluj-Napoca, , Romania

Teva Investigational Site 81536

Cluj-Napoca, , Romania

Teva Investigational Site 81530

Târgu Mureş, , Romania

Teva Investigational Site 81532

Timișoara, , Romania

Teva Investigational Site 81538

Timișoara, , Romania

Teva Investigational Site 70505

Barnaul, , Russia

Teva Investigational Site 70502

Kazan', , Russia

Teva Investigational Site 70511

Moscow, , Russia

Teva Investigational Site 70512

Moscow, , Russia

Teva Investigational Site 70508

Ryazan, , Russia

Teva Investigational Site 70501

Saint Petersburg, , Russia

Teva Investigational Site 70504

Saint Petersburg, , Russia

Teva Investigational Site 70510

Saint Petersburg, , Russia

Teva Investigational Site 70509

Samara, , Russia

Teva Investigational Site 70507

Smolensk, , Russia

Teva Investigational Site 70506

Tomsk, , Russia

Teva Investigational Site 70503

Yaroslavl, , Russia

Teva Investigational Site 81501

Belgrade, , Serbia

Teva Investigational Site 36551

Bloemfontein, , South Africa

Teva Investigational Site 36552

Cape Town, , South Africa

Teva Investigational Site 36555

Cape Town, , South Africa

Teva Investigational Site 36550

Port Elizabeth, , South Africa

Teva Investigational Site 36553

Thabazimbi, , South Africa

Teva Investigational Site 36554

Witbank, , South Africa

Teva Investigational Site 34507

Aranjuez, , Spain

Teva Investigational Site 34501

Badalona, , Spain

Teva Investigational Site 34502

Barcelona, , Spain

Teva Investigational Site 34510

Barcelona, , Spain

Teva Investigational Site 34509

Bilbao, , Spain

Teva Investigational Site 34506

Lleida, , Spain

Teva Investigational Site 34505

Madrid, , Spain

Teva Investigational Site 34503

Salt, , Spain

Teva Investigational Site 34504

Santiago de Compostela, , Spain

Teva Investigational Site 34508

Valencia, , Spain

Teva Investigational Site 34511

Vitoria-Gasteiz, , Spain

Teva Investigational Site 80501

Dnipropetrovsk, , Ukraine

Teva Investigational Site 80513

Dnipropetrovsk, , Ukraine

Teva Investigational Site 80511

Donetsk, , Ukraine

Teva Investigational Site 80502

Kharkiv, , Ukraine

Teva Investigational Site 80503

Kharkiv, , Ukraine

Teva Investigational Site 80504

Kyiv, , Ukraine

Teva Investigational Site 80505

Kyiv, , Ukraine

Teva Investigational Site 80506

Kyiv, , Ukraine

Teva Investigational Site 80507

Kyiv, , Ukraine

Teva Investigational Site 80508

Kyiv, , Ukraine

Teva Investigational Site 80509

Kyiv, , Ukraine

Teva Investigational Site 80517

Kyiv, , Ukraine

Teva Investigational Site 80519

Kyiv, , Ukraine

Teva Investigational Site 80520

Kyiv, , Ukraine

Teva Investigational Site 80521

Kyiv, , Ukraine

Teva Investigational Site 80514

Odesa, , Ukraine

Teva Investigational Site 80516

Simferopol, , Ukraine

Teva Investigational Site 80512

Vinnytsia, , Ukraine

Teva Investigational Site 80515

Yalta, , Ukraine

Teva Investigational Site 80522

Zaporizhia, , Ukraine

Teva Investigational Site 80510

Zaporizhzhia, , Ukraine

Teva Investigational Site 80518

Zaporizhzhya, , Ukraine

Teva Investigational Site 34582

Cottingham, , United Kingdom

Teva Investigational Site 34584

London, , United Kingdom

Teva Investigational Site 34585

Penzance, , United Kingdom

Teva Investigational Site 34580

Torpoint, , United Kingdom

Teva Investigational Site 34581

Watford, , United Kingdom

Countries

United States; Australia; Bulgaria; Canada; Croatia; Germany; Greece; Hungary; Ireland; Israel; New Zealand; Poland; Romania; Russia; Serbia; South Africa; Spain; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27937064 (View on PubMed)

Other Identifiers

2010-023601-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FpS-AS-202

Identifier Type: -

Identifier Source: org_study_id