Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma
NCT ID: NCT02175771
Last Updated: 2021-11-09
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
758 participants
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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Detailed Description
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Patients who met all of the inclusion criteria and none of the exclusion criteria at the screening visit completed a 14 day (±2 days) pretreatment run in period. During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their SABA, which was replaced by the sponsor-provided albuterol (salbutamol) hydrofluoroalkane (HFA) inhaler to be used as needed for symptomatic relief of asthma symptoms during the run in and treatment periods.
Patients were assigned to inhaled corticosteroid (ICS) monotherapy or inhaled corticosteroid/long acting beta2 agonist (ICS/LABA) combination therapy and then to a mid- or high-treatment strength based on their current asthma maintenance therapy regimen. Patients in each strength of the ICS monotherapy cohort were randomly assigned in a 3:1 distribution to either the Fp MDPI or FLOVENT HFA treatment arm. Patients in each strength of the ICS/LABA combination cohort were randomly assigned in a 3:1 distribution to either the FS MDPI or ADVAIR DISKUS treatment arm. There was a total of 8 treatment arms following randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fp MDPI 100 mcg
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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.
During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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 HFA 110 mcg
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
FLOVENT HFA
FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate.
During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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.
During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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 HFA 220 mcg
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
FLOVENT HFA
FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate.
During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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).
FS MDPI 100/12.5 mcg
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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.
During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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).
ADVAIR DISKUS 250/50 mcg
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
ADVAIR DISKUS
ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient.
During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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).
FS MDPI 200/12.5 mcg
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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.
During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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).
ADVAIR DISKUS 500/50 mcg
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
ADVAIR DISKUS
ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient.
During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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
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Fp MDPI
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient.
During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening.
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.
During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening.
FLOVENT HFA
FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate.
During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening.
ADVAIR DISKUS
ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient.
During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening.
albuterol/salbutamol HFA
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have a treatment regimen that includes a short-acting β2 agonist (SABA) (albuterol) for use as needed and either an inhaled corticosteroid (ICS) or an ICS/long-acting β2 agonist (LABA) as a preventative treatment for a minimum of 8 weeks before the SV. Patients currently taking low-dose ICS without LABA are not eligible for this study. Patients currently taking low-dose ICS/LABA may only be entered into the mid ICS strength. All patients must have been maintained on a stable dose of ICS or ICS/LABA for 4 weeks prior to the SV (or pre-SV if necessary) at 1 qualifying doses
3. To meet reversibility of disease criteria, the patient must demonstrate a ≥12% reversibility of FEV1 (and 200 mL for patients aged18 years and older) within 30 minutes following 4 inhalations of albuterol at the SV. Historic reversibility within the past 12 months of the SV may be used to meet this criterion.
4. Written informed consent/assent is obtained. For adult patients (aged 18 years and older, or as applicable per local regulations), the written informed consent form (ICF) must be signed and dated by the patient before conducting any study-related procedure. For minor patients (aged 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) before conducting any study-related procedure. Note: Age requirements are as specified by local regulations.
5. Outpatient \>= 12 years of age on the date of consent/assent. .
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 medication) for at least 30 days before providing informed consent.
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 metered-dose inhaler (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 where spirometry is performed.
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 inhalation aerosol at the SV for use as needed 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 the 30 days preceding the SV (or prescreening visit, as applicable) or plans to participate in another investigational drug study at any time during this study.
4. The patient has previously participated in an Fp MDPI or FS MDPI study.
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 or plans to be treated with any strong CYP3A4 inhibitor during the study.
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 may 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 who initiated immunotherapy 90 days or more before the SV and have been on a stable (maintenance) dose for 30 days or more before the SV 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. (Patients that require continuous treatment with β-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids are excluded).
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, 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
Criteria for Randomization:
Patients were randomized into the study if they met all of the following criteria:
1. The patient continued to be in general good health, meeting the entry criteria.
2. The patient continued to have a predose/pre-albuterol FEV1 at the randomization visit (RV) that was ≥40% of predicted normal.
3. The patient had no clinically significant abnormal laboratory test results or ECG findings at the screening visit.
4. The patient had no significant changes in asthma medications during run-in, excluding the albuterol/salbutamol HFA (90 mcg ex actuator) or equivalent used as rescue medication as supplied per protocol.
5. The patient did not have a upper respiratory tract infection (URI) or lower respiratory tract infection (LRI) during the run in period. Patients who developed a URI or LRI during the run in period could be discontinued from the study and allowed to re-screen 2 weeks after resolution of symptoms.
6. The patient had no asthma exacerbation during the run in period, defined as any worsening of asthma requiring any significant treatment other than rescue albuterol/salbutamol HFA (90 mcg ex actuator) or equivalent or the patient's run-in MDPI. This included requiring the use of systemic corticosteroids and/or emergency department (ED) visit or hospitalization or an increase in the patient's regularly prescribed nonsteroidal maintenance treatment. Urgent care/ED visits where the treatment was limited to a single dose of nebulized albuterol/salbutamol did not meet the criteria of an asthma exacerbation.
7. The patient had no clinical visual evidence (on oropharyngeal examination) of oropharyngeal candidiasis.
8. The patient did not experience an adverse event that would result in failure to continue to meet selection criteria.
9. The patient did not use any of the prohibited concomitant medications during the run in period.
10. The patient complied with completion of the daily diary, defined as follows:
* completion of AM and PM asthma symptom scores on 4 or more of the 7 days immediately preceding the RV.
* completion of rescue medication use (whether used or not) on 4 or more of the 7 days immediately preceding the RV.
* completion of AM peak expiratory flow (PEF) measurements on 4 or more of the 7 days immediately preceding the RV.
* recording of AM and PM asthma inhalation therapy use on 4 or more of the 7 days immediately preceding the RV.
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 12068
Birmingham, Alabama, United States
Teva Investigational Site 12112
Mobile, Alabama, United States
Teva Investigational Site 12130
Pell City, Alabama, United States
Teva Investigational Site 12119
Little Rock, Alaska, United States
Teva Investigational Site 12076
Phoenix, Arizona, United States
Teva Investigational Site 12135
Scottsdale, Arizona, United States
Teva Investigational Site 12132
Tucson, Arizona, United States
Teva Investigational Site 12102
Fountain Valley, California, United States
Teva Investigational Site 12104
Fresno, California, United States
Teva Investigational Site 12123
Fullerton, California, United States
Teva Investigational Site 12103
Huntington Beach, California, United States
Teva Investigational Site 12073
Long Beach, California, United States
Teva Investigational Site 12077
Mission Viejo, California, United States
Teva Investigational Site 12098
Napa, California, United States
Teva Investigational Site 12149
Northridge, California, United States
Teva Investigational Site 12081
Orange, California, United States
Teva Investigational Site 12100
Rancho Mirage, California, United States
Teva Investigational Site 12133
Riverside, California, United States
Teva Investigational Site 12146
Riverside, California, United States
Teva Investigational Site 12075
Rolling Hills Estates, California, United States
Teva Investigational Site 12074
San Diego, California, United States
Teva Investigational Site 12150
San Diego, California, United States
Teva Investigational Site 12064
San Jose, California, United States
Teva Investigational Site 12061
Stockton, California, United States
Teva Investigational Site 12141
Walnut Creek, California, United States
Teva Investigational Site 12043
Denver, Colorado, United States
Teva Investigational Site 12051
Denver, Colorado, United States
Teva Investigational Site 12091
Waterbury, Connecticut, United States
Teva Investigational Site 12078
Fort Lauderdale, Florida, United States
Teva Investigational Site 12140
Hialeah, Florida, United States
Teva Investigational Site 12066
Kissimmee, Florida, United States
Teva Investigational Site 12120
Miami, Florida, United States
Teva Investigational Site 12127
Miami, Florida, United States
Teva Investigational Site 12148
Miami, Florida, United States
Teva Investigational Site 12114
Ocala, Florida, United States
Teva Investigational Site 12055
Sarasota, Florida, United States
Teva Investigational Site 12048
Tallahassee, Florida, United States
Teva Investigational Site 12122
Tamarac, Florida, United States
Teva Investigational Site 12086
Winter Park, Florida, United States
Teva Investigational Site 12111
Gainesville, Georgia, United States
Teva Investigational Site 12070
Lawrenceville, Georgia, United States
Teva Investigational Site 12072
Marietta, Georgia, United States
Teva Investigational Site 12106
Coeur d'Alene, Idaho, United States
Teva Investigational Site 12117
Eagle, Idaho, United States
Teva Investigational Site 12065
River Forest, Illinois, United States
Teva Investigational Site 12059
Shiloh, Illinois, United States
Teva Investigational Site 12056
Overland Park, Kansas, United States
Teva Investigational Site 12138
Fort Mitchell, Kentucky, United States
Teva Investigational Site 12092
Owensboro, Kentucky, United States
Teva Investigational Site 12087
Covington, Louisiana, United States
Teva Investigational Site 12095
Bangor, Maine, United States
Teva Investigational Site 12042
Baltimore, Maryland, United States
Teva Investigational Site 12124
Baltimore, Maryland, United States
Teva Investigational Site 12052
North Dartmouth, Massachusetts, United States
Teva Investigational Site 12139
Minneapolis, Minnesota, United States
Teva Investigational Site 12137
Plymouth, Minnesota, United States
Teva Investigational Site 12079
Columbia, Missouri, United States
Teva Investigational Site 12067
Rolla, Missouri, United States
Teva Investigational Site 12057
St Louis, Missouri, United States
Teva Investigational Site 12060
St Louis, Missouri, United States
Teva Investigational Site 12108
St Louis, Missouri, United States
Teva Investigational Site 12128
Warrensburg, Missouri, United States
Teva Investigational Site 12136
Bellevue, Nebraska, United States
Teva Investigational Site 12115
Las Vegas, Nevada, United States
Teva Investigational Site 12131
Las Vegas, Nevada, United States
Teva Investigational Site 12126
Ocean City, New Jersey, United States
Teva Investigational Site 12129
Verona, New Jersey, United States
Teva Investigational Site 12058
Rochester, New York, United States
Teva Investigational Site 12113
Rockville Centre, New York, United States
Teva Investigational Site 12047
Charlotte, North Carolina, United States
Teva Investigational Site 12085
Charlotte, North Carolina, United States
Teva Investigational Site 12144
Winston-Salem, North Carolina, United States
Teva Investigational Site 12053
Canton, Ohio, United States
Teva Investigational Site 12094
Cincinnati, Ohio, United States
Teva Investigational Site 12105
Cincinnati, Ohio, United States
Teva Investigational Site 12107
Sylvania, Ohio, United States
Teva Investigational Site 12069
Tiffin, Ohio, United States
Teva Investigational Site 12045
Oklahoma City, Oklahoma, United States
Teva Investigational Site 12080
Oklahoma City, Oklahoma, United States
Teva Investigational Site 12083
Oklahoma City, Oklahoma, United States
Teva Investigational Site 12062
Eugene, Oregon, United States
Teva Investigational Site 12097
Medford, Oregon, United States
Teva Investigational Site 12049
Portland, Oregon, United States
Teva Investigational Site 12134
Bryn Mawr, Pennsylvania, United States
Teva Investigational Site 12090
Philadelphia, Pennsylvania, United States
Teva Investigational Site 12089
Providence, Rhode Island, United States
Teva Investigational Site 12088
Warwick, Rhode Island, United States
Teva Investigational Site 12096
Charleston, South Carolina, United States
Teva Investigational Site 12147
Spartanburg, South Carolina, United States
Teva Investigational Site 12121
Dallas, Texas, United States
Teva Investigational Site 12099
El Paso, Texas, United States
Teva Investigational Site 12071
Live Oak, Texas, United States
Teva Investigational Site 12054
San Antonio, Texas, United States
Teva Investigational Site 12145
Waco, Texas, United States
Teva Investigational Site 12046
Murray, Utah, United States
Teva Investigational Site 12041
South Burlington, Vermont, United States
Teva Investigational Site 12125
Richmond, Virginia, United States
Teva Investigational Site 12101
Seattle, Washington, United States
Teva Investigational Site 12109
Spokane, Washington, United States
Teva Investigational Site 12044
Tacoma, Washington, United States
Teva Investigational Site 12082
Greenfield, Wisconsin, United States
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.
Mansfield L, Yiu G, Sakov A, Liu S, Caracta C. A 6-month safety and efficacy study of fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers in persistent asthma. Allergy Asthma Proc. 2017 Jul 24;38(4):264-276. doi: 10.2500/aap.2017.38.4061. Epub 2017 May 24.
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
Review additional registry numbers or institutional identifiers associated with this trial.
FSS-AS-305
Identifier Type: -
Identifier Source: org_study_id