Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma
NCT ID: NCT02139644
Last Updated: 2021-11-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
787 participants
INTERVENTIONAL
2014-06-30
2015-09-30
Brief Summary
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Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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FS MDPI 100 / 12.5 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
FS MDPI
FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.
Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
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).
Beclomethasone dipropionate
QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
FS MDPI 50 / 12.5 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
FS MDPI
FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.
Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
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).
Beclomethasone dipropionate
QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
Fp MDPI 100 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Fp MDPI
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.
Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
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).
Beclomethasone dipropionate
QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
Fp MDPI 50 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Fp MDPI
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.
Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
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).
Beclomethasone dipropionate
QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
Placebo MDPI
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
Placebo MDPI
Placebo administered via a multidose dry powder inhaler (MDPI) one puff in the morning and one puff in the evening for 12 weeks.
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).
Beclomethasone dipropionate
QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
Interventions
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FS MDPI
FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.
Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
Fp MDPI
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.
Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
Placebo MDPI
Placebo administered via a multidose dry powder inhaler (MDPI) one puff in the morning and one puff in the evening for 12 weeks.
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).
Beclomethasone dipropionate
QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use) for a minimum of 8 weeks before the Screening Visit (SV) and a low-dose inhaled corticosteroid (ICS). The low-dose ICS may be either as ICS monotherapy or as an ICS/long-acting beta agonist (LABA) combination. The ICS component of the patient's asthma therapy should be stable for a minimum of 1 months before providing consent.
3. Reversibility of Disease: Patients must have at least 15% reversibility (all patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV. Note: Patients who do not qualify for the study due to failure to meet reversibility will be permitted to perform a retest once within 7 days.
4. Patients must provide written informed consent/assent. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable). Note: Age requirements are as specified by local regulations.
5. Outpatient \>= 12 years of age on the date of consent/assent. In countries where the local regulations permit enrollment of adult patients only, patients must be 18 years of age and older.
6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institutes of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days.
7. The patient is able to perform acceptable and repeatable spirometry.
8. The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter.
9. The patient is able to use a MDI device without a spacer device and a MDPI device.
10. The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the SV and before all treatment visits.
11. The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements.
12. SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol for the duration of the study.
13. Female patients may not be pregnant, breastfeeding, or attempting to become pregnant.
* other criteria may apply, please contact the investigator for more information
Exclusion Criteria
2. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
3. The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV.
4. The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI.
5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose).
6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV.
7. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
8. The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
9. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV.
10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
11. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV.
12. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients on stable immunotherapy may be considered for inclusion.
13. The patient has used immunosuppressive medications within 4 weeks before the SV.
14. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications.
15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
16. The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.
17. The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
18. A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
19. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
* other criteria may apply, please contact the investigator for more information
12 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12397
Birmingham, Alabama, United States
Teva Investigational Site 12375
Glendale, Arizona, United States
Teva Investigational Site 12395
Cypress, California, United States
Teva Investigational Site 12476
Encinitas, California, United States
Teva Investigational Site 12586
Fountain Valley, California, United States
Teva Investigational Site 12591
Fresno, California, United States
Teva Investigational Site 12372
Huntington Beach, California, United States
Teva Investigational Site 12365
Los Angeles, California, United States
Teva Investigational Site 12381
Los Angeles, California, United States
Teva Investigational Site 12401
Los Angeles, California, United States
Teva Investigational Site 12394
Mission Viejo, California, United States
Teva Investigational Site 12490
Rancho Mirage, California, United States
Teva Investigational Site 12393
Riverside, California, United States
Teva Investigational Site 12366
Rolling Hills Estates, California, United States
Teva Investigational Site 12383
San Diego, California, United States
Teva Investigational Site 12370
San Jose, California, United States
Teva Investigational Site 12371
Stockton, California, United States
Teva Investigational Site 12579
Upland, California, United States
Teva Investigational Site 12379
Centennial, Colorado, United States
Teva Investigational Site 12386
Centennial, Colorado, United States
Teva Investigational Site 12596
Colorado Springs, Colorado, United States
Teva Investigational Site 12584
Longmont, Colorado, United States
Teva Investigational Site 12484
Waterbury, Connecticut, United States
Teva Investigational Site 12590
Waterbury, Connecticut, United States
Teva Investigational Site 12493
Clearwater, Florida, United States
Teva Investigational Site 12992
Largo, Florida, United States
Teva Investigational Site 12376
Miami, Florida, United States
Teva Investigational Site 12390
Miami, Florida, United States
Teva Investigational Site 12583
Orlando, Florida, United States
Teva Investigational Site 12481
Tallahassee, Florida, United States
Teva Investigational Site 12491
Winter Park, Florida, United States
Teva Investigational Site 12997
Decatur, Georgia, United States
Teva Investigational Site 12392
Savannah, Georgia, United States
Teva Investigational Site 12592
Shiloh, Illinois, United States
Teva Investigational Site 12483
Lenexa, Kansas, United States
Teva Investigational Site 12399
Baltimore, Maryland, United States
Teva Investigational Site 12391
Bethesda, Maryland, United States
Teva Investigational Site 12589
Columbia, Maryland, United States
Teva Investigational Site 12369
Rockville, Maryland, United States
Teva Investigational Site 12396
Fall River, Massachusetts, United States
Teva Investigational Site 12384
North Dartmouth, Massachusetts, United States
Teva Investigational Site 12585
North Dartmouth, Massachusetts, United States
Teva Investigational Site 12588
Ypsilanti, Michigan, United States
Teva Investigational Site 12494
St Louis, Missouri, United States
Teva Investigational Site 12595
St Louis, Missouri, United States
Teva Investigational Site 12594
Missoula, Montana, United States
Teva Investigational Site 12385
Ocean City, New Jersey, United States
Teva Investigational Site 12380
Skillman, New Jersey, United States
Teva Investigational Site 12587
Brooklyn, New York, United States
Teva Investigational Site 12485
Rockville Centre, New York, United States
Teva Investigational Site 12475
Huntersville, North Carolina, United States
Teva Investigational Site 12364
Raleigh, North Carolina, United States
Teva Investigational Site 12374
Canton, Ohio, United States
Teva Investigational Site 12480
Cincinnati, Ohio, United States
Teva Investigational Site 12492
Cincinnati, Ohio, United States
Teva Investigational Site 12487
Middleburg Heights, Ohio, United States
Teva Investigational Site 12488
Sylvania, Ohio, United States
Teva Investigational Site 12377
Edmond, Oklahoma, United States
Teva Investigational Site 12368
Medford, Oregon, United States
Teva Investigational Site 12382
Portland, Oregon, United States
Teva Investigational Site 12400
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12473
Upland, Pennsylvania, United States
Teva Investigational Site 12389
Greenville, South Carolina, United States
Teva Investigational Site 12580
Mt. Pleasant, South Carolina, United States
Teva Investigational Site 12398
Orangeburg, South Carolina, United States
Teva Investigational Site 12991
Knoxville, Tennessee, United States
Teva Investigational Site 12990
Cypress, Texas, United States
Teva Investigational Site 12373
Dallas, Texas, United States
Teva Investigational Site 12402
El Paso, Texas, United States
Teva Investigational Site 12582
New Braunfels, Texas, United States
Teva Investigational Site 12363
San Antonio, Texas, United States
Teva Investigational Site 12482
San Antonio, Texas, United States
Teva Investigational Site 12477
Waco, Texas, United States
Teva Investigational Site 12478
Murray, Utah, United States
Teva Investigational Site 12388
South Burlington, Vermont, United States
Teva Investigational Site 12378
Milwaukee, Wisconsin, United States
Teva Investigational Site 11065
Toronto, Ontario, Canada
Teva Investigational Site 11067
Montreal, Quebec, Canada
Teva Investigational Site 11068
Vancouver, Quebec, Canada
Teva Investigational Site 54084
Neratovice, , Czechia
Teva Investigational Site 54088
Prague, , Czechia
Teva Investigational Site 54087
Rokycany, , Czechia
Teva Investigational Site 51134
Budapest, , Hungary
Teva Investigational Site 51143
Budapest, , Hungary
Teva Investigational Site 51144
Budapest, , Hungary
Teva Investigational Site 51140
Debrecen, , Hungary
Teva Investigational Site 51142
Deszk, , Hungary
Teva Investigational Site 51165
Dombóvár, , Hungary
Teva Investigational Site 51145
Kiskunhalas, , Hungary
Teva Investigational Site 51141
Miskolc, , Hungary
Teva Investigational Site 51133
Mosdós, , Hungary
Teva Investigational Site 51136
Nyíregyháza, , Hungary
Teva Investigational Site 51139
Nyíregyháza, , Hungary
Teva Investigational Site 51163
Sopron, , Hungary
Teva Investigational Site 51137
Szeged, , Hungary
Teva Investigational Site 51164
Szigetvár, , Hungary
Teva Investigational Site 51138
Szombathely, , Hungary
Teva Investigational Site 53182
Bialystok, , Poland
Teva Investigational Site 53183
Bialystok, , Poland
Teva Investigational Site 53185
Bialystok, , Poland
Teva Investigational Site 53191
Bialystok, , Poland
Teva Investigational Site 53187
Bienkówka, , Poland
Teva Investigational Site 53219
Bydgoszcz, , Poland
Teva Investigational Site 53217
Dębica, , Poland
Teva Investigational Site 53178
Krakow, , Poland
Teva Investigational Site 53180
Krakow, , Poland
Teva Investigational Site 53188
Krakow, , Poland
Teva Investigational Site 53220
Lodz, , Poland
Teva Investigational Site 53235
Lodz, , Poland
Teva Investigational Site 53221
Lódz, , Poland
Teva Investigational Site 53237
Lublin, , Poland
Teva Investigational Site 53194
Poznan, , Poland
Teva Investigational Site 53234
Poznan, , Poland
Teva Investigational Site 53233
Strzelce Opolskie, , Poland
Teva Investigational Site 53179
Tarnów, , Poland
Teva Investigational Site 53218
Tarnów, , Poland
Teva Investigational Site 53193
Warsaw, , Poland
Teva Investigational Site 53181
Wroclaw, , Poland
Teva Investigational Site 53189
Wroclaw, , Poland
Teva Investigational Site 50236
Chelyabinsk, , Russia
Teva Investigational Site 50227
Kazan', , Russia
Teva Investigational Site 50234
Moscow, , Russia
Teva Investigational Site 50238
Moscow, , Russia
Teva Investigational Site 50230
Novosibirsk, , Russia
Teva Investigational Site 50224
Saint Petersburg, , Russia
Teva Investigational Site 50231
Saint Petersburg, , Russia
Teva Investigational Site 50233
Voronezh, , Russia
Teva Investigational Site 50237
Yaroslavl, , Russia
Teva Investigational Site 50226
Yekaterinburg, , Russia
Teva Investigational Site 90002
Cape Town, , South Africa
Teva Investigational Site 90008
Cape Town, , South Africa
Teva Investigational Site 90005
Centurion, , South Africa
Teva Investigational Site 90001
Johannesburg, , South Africa
Teva Investigational Site 90003
Middelburg, , South Africa
Teva Investigational Site 90007
Pretoria, , South Africa
Teva Investigational Site 58125
Kharkiv, , Ukraine
Teva Investigational Site 58126
Kharkiv, , Ukraine
Teva Investigational Site 58127
Kyiv, , Ukraine
Teva Investigational Site 58128
Kyiv, , Ukraine
Teva Investigational Site 58129
Vinnytsia, , Ukraine
Countries
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References
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Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Raphael G, Yiu G, Sakov A, Liu S, Caracta C. Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older. J Asthma. 2018 Jun;55(6):640-650. doi: 10.1080/02770903.2017.1350971. Epub 2017 Aug 31.
Miller DS, Yiu G, Hellriegel ET, Steinfeld J. Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma. Allergy Asthma Proc. 2016 Jul;37(4):291-301. doi: 10.2500/aap.2016.37.3963. Epub 2016 May 27.
Other Identifiers
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2014-001149-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FSS-AS-301
Identifier Type: -
Identifier Source: org_study_id