AzTrials
AzTrials

Persistent AsthmaPhase 3NCT02175771

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

A Phase 3 study testing Fp MDPI, FS MDPI and FLOVENT HFA in people with Persistent Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 101 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Persistent Asthma
What is being tested?
Fp MDPI, FS MDPI and FLOVENT HFA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
758 participants
Where
101 sitesUnited States
Study dates
Jul 2014to Jul 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.
  • 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.
  • 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.
  • The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
  • 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.
  • 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:
  • The patient continued to be in general good health, meeting the entry criteria.
  • The patient continued to have a predose/pre-albuterol FEV1 at the randomization visit (RV) that was ≥40% of predicted normal.
  • The patient had no clinically significant abnormal laboratory test results or ECG findings at the screening visit.
  • 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.
  • 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.
  • 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.
  • The patient had no clinical visual evidence (on oropharyngeal examination) of oropharyngeal candidiasis.
  • The patient did not experience an adverse event that would result in failure to continue to meet selection criteria.
  • The patient did not use any of the prohibited concomitant medications during the run in period.
  • 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.

Trial locations and contacts

101 sites in 1 country.

101 sites in 1 country

United States101 sites

  • Teva Investigational Site 12042

    Baltimore, Maryland

  • Teva Investigational Site 12124

    Baltimore, Maryland

  • Teva Investigational Site 12095

    Bangor, Maine

  • Teva Investigational Site 12136

    Bellevue, Nebraska

  • Teva Investigational Site 12068

    Birmingham, Alabama

  • Teva Investigational Site 12134

    Bryn Mawr, Pennsylvania

  • Teva Investigational Site 12053

    Canton, Ohio

  • Teva Investigational Site 12096

    Charleston, South Carolina

  • Teva Investigational Site 12047

    Charlotte, North Carolina

  • Teva Investigational Site 12085

    Charlotte, North Carolina

  • Teva Investigational Site 12094

    Cincinnati, Ohio

  • Teva Investigational Site 12105

    Cincinnati, Ohio

  • Teva Investigational Site 12106

    Coeur d'Alene, Idaho

  • Teva Investigational Site 12079

    Columbia, Missouri

  • Teva Investigational Site 12087

    Covington, Louisiana

  • Teva Investigational Site 12121

    Dallas, Texas

  • Teva Investigational Site 12043

    Denver, Colorado

  • Teva Investigational Site 12051

    Denver, Colorado

  • Teva Investigational Site 12117

    Eagle, Idaho

  • Teva Investigational Site 12099

    El Paso, Texas

  • Teva Investigational Site 12062

    Eugene, Oregon

  • Teva Investigational Site 12078

    Fort Lauderdale, Florida

  • Teva Investigational Site 12138

    Fort Mitchell, Kentucky

  • Teva Investigational Site 12102

    Fountain Valley, California

  • Teva Investigational Site 12104

    Fresno, California

  • Teva Investigational Site 12123

    Fullerton, California

  • Teva Investigational Site 12111

    Gainesville, Georgia

  • Teva Investigational Site 12082

    Greenfield, Wisconsin

  • Teva Investigational Site 12140

    Hialeah, Florida

  • Teva Investigational Site 12103

    Huntington Beach, California

  • Teva Investigational Site 12066

    Kissimmee, Florida

  • Teva Investigational Site 12115

    Las Vegas, Nevada

  • Teva Investigational Site 12131

    Las Vegas, Nevada

  • Teva Investigational Site 12070

    Lawrenceville, Georgia

  • Teva Investigational Site 12119

    Little Rock, Alaska

  • Teva Investigational Site 12071

    Live Oak, Texas

  • Teva Investigational Site 12073

    Long Beach, California

  • Teva Investigational Site 12072

    Marietta, Georgia

  • Teva Investigational Site 12097

    Medford, Oregon

  • Teva Investigational Site 12120

    Miami, Florida

  • Teva Investigational Site 12127

    Miami, Florida

  • Teva Investigational Site 12148

    Miami, Florida

  • Teva Investigational Site 12139

    Minneapolis, Minnesota

  • Teva Investigational Site 12077

    Mission Viejo, California

  • Teva Investigational Site 12112

    Mobile, Alabama

  • Teva Investigational Site 12046

    Murray, Utah

  • Teva Investigational Site 12098

    Napa, California

  • Teva Investigational Site 12052

    North Dartmouth, Massachusetts

  • Teva Investigational Site 12149

    Northridge, California

  • Teva Investigational Site 12114

    Ocala, Florida

  • Teva Investigational Site 12126

    Ocean City, New Jersey

  • Teva Investigational Site 12045

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12080

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12083

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12081

    Orange, California

  • Teva Investigational Site 12056

    Overland Park, Kansas

  • Teva Investigational Site 12092

    Owensboro, Kentucky

  • Teva Investigational Site 12130

    Pell City, Alabama

  • Teva Investigational Site 12090

    Philadelphia, Pennsylvania

  • Teva Investigational Site 12076

    Phoenix, Arizona

  • Teva Investigational Site 12137

    Plymouth, Minnesota

  • Teva Investigational Site 12049

    Portland, Oregon

  • Teva Investigational Site 12089

    Providence, Rhode Island

  • Teva Investigational Site 12100

    Rancho Mirage, California

  • Teva Investigational Site 12125

    Richmond, Virginia

  • Teva Investigational Site 12065

    River Forest, Illinois

  • Teva Investigational Site 12133

    Riverside, California

  • Teva Investigational Site 12146

    Riverside, California

  • Teva Investigational Site 12058

    Rochester, New York

  • Teva Investigational Site 12113

    Rockville Centre, New York

  • Teva Investigational Site 12067

    Rolla, Missouri

  • Teva Investigational Site 12075

    Rolling Hills Estates, California

  • Teva Investigational Site 12054

    San Antonio, Texas

  • Teva Investigational Site 12074

    San Diego, California

  • Teva Investigational Site 12150

    San Diego, California

  • Teva Investigational Site 12064

    San Jose, California

  • Teva Investigational Site 12055

    Sarasota, Florida

  • Teva Investigational Site 12135

    Scottsdale, Arizona

  • Teva Investigational Site 12101

    Seattle, Washington

  • Teva Investigational Site 12059

    Shiloh, Illinois

  • Teva Investigational Site 12041

    South Burlington, Vermont

  • Teva Investigational Site 12147

    Spartanburg, South Carolina

  • Teva Investigational Site 12109

    Spokane, Washington

  • Teva Investigational Site 12057

    St Louis, Missouri

  • Teva Investigational Site 12060

    St Louis, Missouri

  • Teva Investigational Site 12108

    St Louis, Missouri

  • Teva Investigational Site 12061

    Stockton, California

  • Teva Investigational Site 12107

    Sylvania, Ohio

  • Teva Investigational Site 12044

    Tacoma, Washington

  • Teva Investigational Site 12048

    Tallahassee, Florida

  • Teva Investigational Site 12122

    Tamarac, Florida

  • Teva Investigational Site 12069

    Tiffin, Ohio

  • Teva Investigational Site 12132

    Tucson, Arizona

  • Teva Investigational Site 12129

    Verona, New Jersey

  • Teva Investigational Site 12145

    Waco, Texas

  • Teva Investigational Site 12141

    Walnut Creek, California

  • Teva Investigational Site 12128

    Warrensburg, Missouri

  • Teva Investigational Site 12088

    Warwick, Rhode Island

  • Teva Investigational Site 12091

    Waterbury, Connecticut

  • Teva Investigational Site 12144

    Winston-Salem, North Carolina

  • Teva Investigational Site 12086

    Winter Park, Florida

Other trials in United States

About this study

Official title: A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years of Age and Older With Persistent Asthma

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.

Read the detailed description

This was a stratified, randomized, open-label, active drug-controlled Phase 3 study.

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.

Being tested
Fp MDPI, FS MDPI, FLOVENT HFA, ADVAIR DISKUS, albuterol/salbutamol HFA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fp MDPIDrug

    Also called fluticasone propionate, inhaled corticosteroid

    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 MDPIDrug

    Also called fluticasone propionate, inhaled corticosteroid, Salmeterol xinafoate, β2 adrenoceptor agonist

    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 HFADrug

    Also called fluticasone propionate, inhaled corticosteroid

    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 DISKUSDrug

    Also called fluticasone propionate, inhaled corticosteroid, salmeterol xinafoate, β2 adrenoceptor agonist

    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 HFADrug

    Also called ProAir HFA, short-acting β2-adrenergic agonists

    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).

Study groups in NCT02175771
Study groupRoleWhat they receive
Fp MDPI 100 mcgExperimentalParticipants 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.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol HFA
FLOVENT HFA 110 mcgActive comparatorParticipants 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.
Receives: Drug: FLOVENT HFA; Drug: albuterol/salbutamol HFA
Fp MDPI 200 mcgExperimentalParticipants 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.
Receives: Drug: Fp MDPI; Drug: albuterol/salbutamol HFA
FLOVENT HFA 220 mcgActive comparatorParticipants 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.
Receives: Drug: FLOVENT HFA; Drug: albuterol/salbutamol HFA
FS MDPI 100/12.5 mcgExperimentalParticipants 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.
Receives: Drug: FS MDPI; Drug: albuterol/salbutamol HFA
ADVAIR DISKUS 250/50 mcgActive comparatorParticipants 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.
Receives: Drug: ADVAIR DISKUS; Drug: albuterol/salbutamol HFA
FS MDPI 200/12.5 mcgExperimentalParticipants 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.
Receives: Drug: FS MDPI; Drug: albuterol/salbutamol HFA
ADVAIR DISKUS 500/50 mcgActive comparatorParticipants 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.
Receives: Drug: ADVAIR DISKUS; Drug: albuterol/salbutamol HFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 to Week 26 of the Treatment Period

Secondary outcomes (5)

  1. Participants With Positive Swab Test Results for Oral Candidiasis

    Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.

    This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol.

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

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

    Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period.

    Significance criteria:

    • Systolic blood pressure - high: >=180 and increase >=20 mmHg
    • Systolic blood pressure - low: <=90 and decrease >=20 mmHg
    • Diastolic blood pressure - high: >=105 and increase of >=15 mmHg
    • Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg
    • Pulse - high: >=120 and increase of >= 15 beats/minute from baseline
    • Pulse - low: <=50 and decrease of >=15 beats/minute

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

  3. Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings

    A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward.

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

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

    Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol.

    The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model.

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

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

    Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded.

    The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02175771
Sponsor's protocol ID
FSS-AS-305
Status last verified
Nov 2021
First submitted
24 Jun 2014
Last updated
9 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • 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.

    PubMed 36472162

  • 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.

    PubMed 28540844

  • 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.

    PubMed 27216137

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fp MDPI, FS MDPI and FLOVENT HFA in people with Persistent Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 101 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (time frame: Day 1 to Week 26 of the Treatment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02175771, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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