Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma

NCT02175771 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FSS-AS-305
• Study Type: interventional
• Target: 758
• Locations: 1 country
• Sites: 101

Brief Summary

The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.

Conditions

Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period

  An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

  Day 1 to Week 26 of the Treatment Period

Secondary Outcomes (5)

• Participants With Positive Swab Test Results for Oral Candidiasis

  Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint

• Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period

  Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint

• Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings

  Screening (Day -14), Endpoint (week 26 if study was completed)

• Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period

  Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable

• Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period

  Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable

Study Arms (8)

Fp MDPI 100 mcg

EXPERIMENTAL

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.

Drug: Fp MDPI; Drug: albuterol/salbutamol HFA

FLOVENT HFA 110 mcg

ACTIVE COMPARATOR

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.

Drug: FLOVENT HFA; Drug: albuterol/salbutamol HFA

Fp MDPI 200 mcg

EXPERIMENTAL

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.

Drug: Fp MDPI; Drug: albuterol/salbutamol HFA

FLOVENT HFA 220 mcg

ACTIVE COMPARATOR

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.

Drug: FLOVENT HFA; Drug: albuterol/salbutamol HFA

FS MDPI 100/12.5 mcg

EXPERIMENTAL

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.

Drug: FS MDPI; Drug: albuterol/salbutamol HFA

ADVAIR DISKUS 250/50 mcg

ACTIVE COMPARATOR

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.

Drug: ADVAIR DISKUS; Drug: albuterol/salbutamol HFA

FS MDPI 200/12.5 mcg

EXPERIMENTAL

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.

Drug: FS MDPI; Drug: albuterol/salbutamol HFA

ADVAIR DISKUS 500/50 mcg

ACTIVE COMPARATOR

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.

Drug: ADVAIR DISKUS; Drug: albuterol/salbutamol HFA

Interventions

Fp MDPI DRUG

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.

Also known as: fluticasone propionate, inhaled corticosteroid

Fp MDPI 100 mcg; Fp MDPI 200 mcg

FS MDPI DRUG

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.

Also known as: fluticasone propionate, inhaled corticosteroid, Salmeterol xinafoate, β2 adrenoceptor agonist

FS MDPI 100/12.5 mcg; FS MDPI 200/12.5 mcg

FLOVENT HFA DRUG

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.

Also known as: fluticasone propionate, inhaled corticosteroid

FLOVENT HFA 110 mcg; FLOVENT HFA 220 mcg

ADVAIR DISKUS DRUG

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.

Also known as: fluticasone propionate, inhaled corticosteroid, salmeterol xinafoate, β2 adrenoceptor agonist

ADVAIR DISKUS 250/50 mcg; ADVAIR DISKUS 500/50 mcg

albuterol/salbutamol HFA DRUG

A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Also known as: ProAir HFA, short-acting β2-adrenergic agonists

ADVAIR DISKUS 250/50 mcg; ADVAIR DISKUS 500/50 mcg; FLOVENT HFA 110 mcg; FLOVENT HFA 220 mcg; FS MDPI 100/12.5 mcg; FS MDPI 200/12.5 mcg; Fp MDPI 100 mcg; Fp MDPI 200 mcg

Eligibility Criteria

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

You may qualify if:

• Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of greater than 40% of their predicted normal value.
• 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
• 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.
• 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.
• Outpatient \>= 12 years of age on the date of consent/assent. .
• 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.
• The patient is able to perform acceptable and repeatable spirometry.
• The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter.
• The patient is able to use a metered-dose inhaler (MDI) device without a spacer device and a MDPI device.
• 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.
• 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.
• 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.
• Female patients may not be pregnant, breastfeeding, or attempting to become pregnant.
• Other criteria may apply, please contact the investigator for more information

You may not qualify if:

• The patient has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
• The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
• 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.
• The patient has previously participated in an Fp MDPI or FS MDPI study.
• 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).
• 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.
• The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
• 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).
• 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.
• The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
• 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.
• The patient has used immunosuppressive medications within 4 weeks before the SV.
• 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).
• 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.
• The patient has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.

Sponsors & Collaborators

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

Study Sites (101)

Teva Investigational Site 12068

Birmingham, Alabama, United States

Location

Teva Investigational Site 12112

Mobile, Alabama, United States

Location

Teva Investigational Site 12130

Pell City, Alabama, United States

Location

Teva Investigational Site 12119

Little Rock, Alaska, United States

Location

Teva Investigational Site 12076

Phoenix, Arizona, United States

Location

Teva Investigational Site 12135

Scottsdale, Arizona, United States

Location

Teva Investigational Site 12132

Tucson, Arizona, United States

Location

Teva Investigational Site 12102

Fountain Valley, California, United States

Location

Teva Investigational Site 12104

Fresno, California, United States

Location

Teva Investigational Site 12123

Fullerton, California, United States

Location

Teva Investigational Site 12103

Huntington Beach, California, United States

Location

Teva Investigational Site 12073

Long Beach, California, United States

Location

Teva Investigational Site 12077

Mission Viejo, California, United States

Location

Teva Investigational Site 12098

Napa, California, United States

Location

Teva Investigational Site 12149

Northridge, California, United States

Location

Teva Investigational Site 12081

Orange, California, United States

Location

Teva Investigational Site 12100

Rancho Mirage, California, United States

Location

Teva Investigational Site 12133

Riverside, California, United States

Location

Teva Investigational Site 12146

Riverside, California, United States

Location

Teva Investigational Site 12075

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 12074

San Diego, California, United States

Location

Teva Investigational Site 12150

San Diego, California, United States

Location

Teva Investigational Site 12064

San Jose, California, United States

Location

Teva Investigational Site 12061

Stockton, California, United States

Location

Teva Investigational Site 12141

Walnut Creek, California, United States

Location

Teva Investigational Site 12043

Denver, Colorado, United States

Location

Teva Investigational Site 12051

Denver, Colorado, United States

Location

Teva Investigational Site 12091

Waterbury, Connecticut, United States

Location

Teva Investigational Site 12078

Fort Lauderdale, Florida, United States

Location

Teva Investigational Site 12140

Hialeah, Florida, United States

Location

Teva Investigational Site 12066

Kissimmee, Florida, United States

Location

Teva Investigational Site 12120

Miami, Florida, United States

Location

Teva Investigational Site 12127

Miami, Florida, United States

Location

Teva Investigational Site 12148

Miami, Florida, United States

Location

Teva Investigational Site 12114

Ocala, Florida, United States

Location

Teva Investigational Site 12055

Sarasota, Florida, United States

Location

Teva Investigational Site 12048

Tallahassee, Florida, United States

Location

Teva Investigational Site 12122

Tamarac, Florida, United States

Location

Teva Investigational Site 12086

Winter Park, Florida, United States

Location

Teva Investigational Site 12111

Gainesville, Georgia, United States

Location

Teva Investigational Site 12070

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 12072

Marietta, Georgia, United States

Location

Teva Investigational Site 12106

Coeur d'Alene, Idaho, United States

Location

Teva Investigational Site 12117

Eagle, Idaho, United States

Location

Teva Investigational Site 12065

River Forest, Illinois, United States

Location

Teva Investigational Site 12059

Shiloh, Illinois, United States

Location

Teva Investigational Site 12056

Overland Park, Kansas, United States

Location

Teva Investigational Site 12138

Fort Mitchell, Kentucky, United States

Location

Teva Investigational Site 12092

Owensboro, Kentucky, United States

Location

Teva Investigational Site 12087

Covington, Louisiana, United States

Location

Teva Investigational Site 12095

Bangor, Maine, United States

Location

Teva Investigational Site 12042

Baltimore, Maryland, United States

Location

Teva Investigational Site 12124

Baltimore, Maryland, United States

Location

Teva Investigational Site 12052

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 12139

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 12137

Plymouth, Minnesota, United States

Location

Teva Investigational Site 12079

Columbia, Missouri, United States

Location

Teva Investigational Site 12067

Rolla, Missouri, United States

Location

Teva Investigational Site 12057

St Louis, Missouri, United States

Location

Teva Investigational Site 12060

St Louis, Missouri, United States

Location

Teva Investigational Site 12108

St Louis, Missouri, United States

Location

Teva Investigational Site 12128

Warrensburg, Missouri, United States

Location

Teva Investigational Site 12136

Bellevue, Nebraska, United States

Location

Teva Investigational Site 12115

Las Vegas, Nevada, United States

Location

Teva Investigational Site 12131

Las Vegas, Nevada, United States

Location

Teva Investigational Site 12126

Ocean City, New Jersey, United States

Location

Teva Investigational Site 12129

Verona, New Jersey, United States

Location

Teva Investigational Site 12058

Rochester, New York, United States

Location

Teva Investigational Site 12113

Rockville Centre, New York, United States

Location

Teva Investigational Site 12047

Charlotte, North Carolina, United States

Location

Teva Investigational Site 12085

Charlotte, North Carolina, United States

Location

Teva Investigational Site 12144

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 12053

Canton, Ohio, United States

Location

Teva Investigational Site 12094

Cincinnati, Ohio, United States

Location

Teva Investigational Site 12105

Cincinnati, Ohio, United States

Location

Teva Investigational Site 12107

Sylvania, Ohio, United States

Location

Teva Investigational Site 12069

Tiffin, Ohio, United States

Location

Teva Investigational Site 12045

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 12080

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 12083

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 12062

Eugene, Oregon, United States

Location

Teva Investigational Site 12097

Medford, Oregon, United States

Location

Teva Investigational Site 12049

Portland, Oregon, United States

Location

Teva Investigational Site 12134

Bryn Mawr, Pennsylvania, United States

Location

Teva Investigational Site 12090

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 12089

Providence, Rhode Island, United States

Location

Teva Investigational Site 12088

Warwick, Rhode Island, United States

Location

Teva Investigational Site 12096

Charleston, South Carolina, United States

Location

Teva Investigational Site 12147

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 12121

Dallas, Texas, United States

Location

Teva Investigational Site 12099

El Paso, Texas, United States

Location

Teva Investigational Site 12071

Live Oak, Texas, United States

Location

Teva Investigational Site 12054

San Antonio, Texas, United States

Location

Teva Investigational Site 12145

Waco, Texas, United States

Location

Teva Investigational Site 12046

Murray, Utah, United States

Location

Teva Investigational Site 12041

South Burlington, Vermont, United States

Location

Teva Investigational Site 12125

Richmond, Virginia, United States

Location

Teva Investigational Site 12101

Seattle, Washington, United States

Location

Teva Investigational Site 12109

Spokane, Washington, United States

Location

Teva Investigational Site 12044

Tacoma, Washington, United States

Location

Teva Investigational Site 12082

Greenfield, Wisconsin, United States

Location

Related Publications (3)

• 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.

  PMID: 36472162 DERIVED

• 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.

  PMID: 28540844 DERIVED

• 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.

  PMID: 27216137 DERIVED

MeSH Terms

Interventions

Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Albuterol

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

ustevatrials@tevapharm.com

1-215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 9, 2021
• Results First Posted: April 14, 2017

Record last verified: 2021-11

Locations

US (101)