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AsthmaNCT02649478

Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate

A study testing Fluticasone / Salmeterol and Advair Diskus 100/50 in people with Asthma, run by Roxane Laboratories at 100 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

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Fluticasone / Salmeterol and Advair Diskus 100/50
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,430 participants
Where
100 sitesUnited States
Study dates
Aug 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

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

  • Male and female subjects must be 12 years of age or older. Females must be of non-childbearing potential or if of childbearing potential, must commit to consistent use of a form of birth control which is medically effective.
  • Be able to provide written informed consent or, in the case of adolescents, informed assent in addition to an informed consent form signed by the adolescent's parent(s) or legal guardian(s).
  • Be current non-smokers and also may not have used tobacco products (e.g., cigarettes, cigars, pipe tobacco) within the year prior to Visit 1, and have 10 years or less (10 pack-years for cigarettes) of historical use.
  • Have persistent asthma, as defined by the National Asthma Education and Prevention Program, for at least 12 weeks before Visit 1.
  • The forced expiratory volume at one second ("FEV1") range required for enrollment is dependent on whether the subject is an adult or adolescent and whether he or she is currently treated with inhaled corticosteroids ("ICS") at Visit 1
  • Demonstrate 15% or greater reversibility of FEV1 between 10 and 30 minutes following 360 µg of albuterol inhalation. NOTE: If the subject does not meet criterion 6 at Visit 1 (Day -14), this criterion must be met at Visit 2 (Day -1).
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  • Be able to discontinue controller asthma medication (including leukotriene modifiers ("LTM"), ICS and long acting β-agonists (LABAs)) during the Run-in Period and Treatment Period.
  • Be able to replace current short-acting β-agonists (SABAs) with the study-supplied albuterol (or equivalent) rescue medication inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for a least 6 hours before lung function assessments during study visits).
  • Be appropriately using 1 of the following asthma-treatment regimens and meet the associated criteria:
  • Low- to medium-dose ICS for at least 4 weeks before Visit 1, with or without an adjunctive asthma therapy (i.e., LABA, LTM, or theophylline). Both the ICS dose and overall daily asthma regimen must have been stable for the 4 weeks before Visit 1; or
  • Leukotriene modifier (such as montelukast, zafirlukast, or pranlukast) or theophylline as monotherapy at a stable dose for at least 4 weeks before Visit 1;or
  • Daily (or near daily) rescue medication (e.g., albuterol/ salbutamol or other inhaled SABA used to treat acute asthma) in the 4 weeks before Visit 1.
  • Must not have been treated (for any reason) with oral or parenteral corticosteroids for at least 1 month before Visit 1 and must not have used oral SABAs for at least 12 hours before Visit 1 and for the remainder of the study. Routine use of oral/parenteral corticosteroids and oral SABAs is not allowed after Visit 1.
  • Subjects may continue using short-acting forms of theophylline (withheld at least 12 hours before a site visit), twice daily controlled release forms of theophylline (withheld at least 24 hours before a site visit), and once daily controlled-release forms of theophylline (withheld at least 36 hours before a site visit).
  • Be able to answer questions regarding asthma status and be able to document) device usage and asthma status on a twice daily basis.
  • NOTE: Placebo inhaler use (i.e., compliance) must be at least 75% of the planned doses taken as assessed at Visit 2, for the subject to be considered eligible to continue in the study.
  • Demonstrate proper use of metered dose inhaler ("MDI") and dry-powder inhaler devices.

Who cannot join

  • Have an Asthma Control Questionnaire (ACQ) score of 3.0 or greater at Visit 1.
  • Are unable to discontinue ICS, LABA, or LTM.
  • Have a history of life-threatening asthma, defined as an asthma episode (at any time in the past) associated with any of the following: respiratory arrest or intubation, hypercapnia, hypoxic seizures, or syncopal episode.
  • Have exercise-induced asthma as the only asthma-related diagnosis that does not require daily asthma control medicine.
  • Have evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
  • Have current clinical evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
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  • Have obstructive sleep apnea severe enough to require biphasic or continuous positive-airway pressure therapy, or likely to interfere with the assessment of asthma symptoms, in the investigator's judgment.
  • Using medication with the potential to affect the course of asthma or interact with sympathomimetic amines (e.g., β blockers [including eye drops], oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors).
  • Had a viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks before Visit 1 or have an infection during the Run-in Period.
  • Participated in an interventional study or used any investigational drug for any disease within 30 days (or 4 half lives, if this is longer than 30 days) before Visit 1 before Visit 1.
  • Used an anti-immunoglobulin E (e.g., omalizumab) or any other monoclonal antibody for any reason within 6 months before Visit 1.
  • Are hypersensitive to any β2-agonist sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or any component of these combination medications including severe milk protein hypersensitivity.
  • Are exhibiting any factors (e.g., infirmity, disability, or geographic location, inability to follow instructions or study compliance requirements) that the investigator believes would likely limit the subject's compliance with the study protocol or scheduled site visits. This includes recent history of substance abuse or uncontrolled psychiatric or neurological behavior that would render the subject incapable of reliably following study requirements, in the judgment of the investigator.
  • Have an affiliation with the participating site; in other words, subject may not be an immediate family member of any study site staff and may not be employed directly or indirectly by the study site.

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

  • Roxane Laboratories Research Site #55

    Ann Arbor, Michigan, 48106

  • Roxane Laboratories Research Site #10

    Atco, New Jersey, 08004

  • Roxane Laboratories Research Site #84

    Bakersfield, California, 93301

  • Roxane Laboratories Research Site #62

    Baltimore, Maryland, 21225

  • Roxane Laboratories Research Site #52

    Baltimore, Maryland, 21236

  • Roxane Laboratories Research Site #32

    Bellevue, Nebraska, 68005

  • Roxane Laboratories Research Site #25

    Bellevue, Nebraska, 68123

  • Roxane Laboratories Research Site #71

    Bethesda, Maryland, 20814

  • Roxane Laboratories Research Site #27

    Boerne, Texas, 78006

  • Roxane Laboratories Research Site #100

    Brownsburg, Indiana, 46112

  • Roxane Laboratories Research Site #33

    Centennial, Colorado, 80112

  • Roxane Laboratories Research Site #97

    Chelsea, Michigan, 48118

  • Roxane Laboratories Research Site #31

    Cincinnati, Ohio, 45242

  • Roxane Laboratories Research Site #41

    Clemmons, North Carolina, 27012

  • Roxane Laboratories Research Site #95

    Columbus, Ohio, 43214

  • Roxane Laboratories Research Site #72

    Costa Mesa, California, 92626

  • Roxane Laboratories Research Site #75

    Dallas, Texas, 75231

  • Roxane Laboratories Research Site #43

    Denver, Colorado, 80246

  • Roxane Laboratories Research Site #63

    Denver, Colorado, 80246

  • Roxane Laboratories Research Site #14

    Edmond, Oklahoma, 73034

  • Roxane Laboratories Research Site #49

    El Paso, Texas, 79903

  • Roxane Laboratories Research Site #67

    Encinitas, California, 92024

  • Roxane Laboratories Research Site #37

    Eugene, Oregon, 97401

  • Roxane Laboratories Research Site #81

    Fall River, Massachusetts, 02720

  • Roxane Laboratories Research Site #4

    Fountain Valley, California, 90708

  • Roxane Laboratories Research Site #64

    Fullerton, California, 92835

  • Roxane Laboratories Research Site #30

    Glendale, Arizona, 85306

  • Roxane Laboratories Research Site #82

    Greenfield, Wisconsin, 53228

  • Roxane Laboratories Research Site #69

    Greenville, South Carolina, 29615

  • Roxane Laboratories Research Site #9

    Henrico, Virginia, 23233

  • Roxane Laboratories Research Site #50

    Hialeah, Florida, 33012

  • Roxane Laboratories Research Site #11

    Hialeah, Florida, 33016

  • Roxane Laboratories Research Site #24

    Hilliard, Ohio, 43026

  • Roxane Laboratories Research Site #66

    Homestead, Florida, 33030

  • Roxane Laboratories Research Site #44

    Houston, Texas, 77043

  • Roxane Laboratories Research Site #3

    Huntington Beach, California, 92647

  • Roxane Laboratories Research Site #70

    Huntington Beach, California, 92647

  • Roxane Laboratories Research Site #92

    Huntington Beach, California, 92647

  • Roxane Laboratories Research Site #38

    Irvine, California, 92614

  • Roxane Laboratories Research Site #83

    Jupiter, Florida, 33458

  • Roxane Laboratories Research Site #57

    Las Vegas, Nevada, 89119

  • Roxane Laboratories Research Site #77

    Lewisville, Texas, 75067

  • Roxane Laboratories Research Site #34

    Lilburn, Georgia, 30047

  • Roxane Laboratories Research Site #91

    Lincoln, California, 95648

  • Roxane Laboratories Research Site #59

    Los Angeles, California, 90017

  • Roxane Laboratories Research Site #16

    Los Angeles, California, 90025

  • Roxane Laboratories Research Site #90

    Los Angeles, California, 90048

  • Roxane Laboratories Research Site #40

    Medford, Oregon, 97504

  • Roxane Laboratories Research Site #8

    Miami, Florida, 33126

  • Roxane Laboratories Research Site #23

    Miami, Florida, 33135

  • Roxane Laboratories Research Site #86

    Miami, Florida, 33144

  • Roxane Laboratories Research Site #89

    Miami, Florida, 33144

  • Roxane Laboratories Research Site #20

    Miami, Florida, 33155

  • Roxane Laboratories Research Site #68

    Miami, Florida, 33165

  • Roxane Laboratories Research Site #80

    Miami, Florida, 33173

  • Roxane Laboratories Research Site #54

    Miami, Florida, 33174

  • Roxane Laboratories Research Site #12

    Miami, Florida, 33185

  • Roxane Laboratories Research Site #61

    Middleburg Heights, Ohio, 44130

  • Roxane Laboratories Research Site #6

    Mission Viejo, California, 92691

  • Roxane Laboratories Research Site #7

    New York, New York, 10018

  • Roxane Laboratories Research Site #2

    New York, New York, 10019

  • Roxane Laboratories Research Site #79

    Normal, Illinois, 61761

  • Roxane Laboratories Research Site #56

    North Dartmouth, Massachusetts, 02747

  • Roxane Laboratories Research Site #74

    North Miami Beach, Florida, 33162

  • Roxane Laboratories Research Site #15

    Oklahoma City, Oklahoma, 73103

  • Roxane Laboratories Research Site #36

    Omaha, Nebraska, 68114

  • Roxane Laboratories Research Site #35

    Orlando, Florida, 32806

  • Roxane Laboratories Research Site #17

    Orlando, Florida, 32825

  • Roxane Laboratories Research Site #46

    Phoenix, Arizona, 85018

  • Roxane Laboratories Research Site #87

    Plano, Texas, 75093

  • Roxane Laboratories Research Site #5

    Plymouth, Minnesota, 55441

  • Roxane Laboratories Research Site #94

    Port Orange, Florida, 32127

  • Roxane Laboratories Research Site #58

    Portland, Oregon, 97202

  • Roxane Laboratories Research Site #45

    Raleigh, North Carolina, 27607

  • Roxane Laboratories Research Site #88

    Richmond, Virginia, 23220

  • Roxane Laboratories Research Site #18

    Richmond, Virginia, 23235

  • Roxane Laboratories Research Site #51

    Rincon, Georgia, 31326

  • Roxane Laboratories Research Site #47

    River Forest, Illinois, 60305

  • Roxane Laboratories Research Site #78

    Rolling Hills Estates, California, 90274

  • Roxane Laboratories Research Site #98

    Sacramento, California, 95821

  • Roxane Laboratories Research Site #29

    San Antonio, Texas, 78251

  • Roxane Laboratories Research Site #48

    San Antonio, Texas, 78258

  • Roxane Laboratories Research Site #53

    San Diego, California, 92103

  • Roxane Laboratories Research Site #93

    San Diego, California, 92123

  • Roxane Laboratories Research Site #28

    San Jose, California, 95117

  • Roxane Laboratories Research Site #60

    Santa Monica, California, 90404

  • Roxane Laboratories Research Site #96

    Silver Spring, Maryland, 20902

  • Roxane Laboratories Research Site #65

    Skillman, New Jersey, 08558

  • Roxane Laboratories Research Site #19

    Smyrna, Tennessee, 37167

  • Roxane Laboratories Research Site #39

    South Burlington, Vermont, 05403

  • Roxane Laboratories Research Site #22

    Spartanburg, South Carolina, 29303

  • Roxane Laboratories Research Site #85

    St Louis, Missouri, 63141

  • Roxane Laboratories Research Site #1

    Surprise, Arizona, 85374

  • Roxane Laboratories Research Site #76

    Tacoma, Washington, 98405

  • Roxane Laboratories Research Site #13

    Tempe, Arizona, 85283

  • Roxane Laboratories Research Site #73

    Toledo, Ohio, 43617

  • Roxane Laboratories Research Site #26

    Warwick, Rhode Island, 02886

  • Roxane Laboratories Research Site #99

    Warwick, Rhode Island, 02886

  • Roxane Laboratories Research Site #42

    West Jordan, Utah, 84088

  • Roxane Laboratories Research Site #21

    Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder Compared With Advair Diskus® 100/50 in Subjects With Asthma

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma

Read the detailed description

The primary objective of this study is to evaluate the clinical bioequivalence of generic fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder (test) to Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma.

The secondary objectives of the study are:

  • To demonstrate statistical superiority of generic fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder to placebo.
  • To demonstrate statistical superiority of Advair 100/50 to placebo.
  • To investigate the safety and tolerability of fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder compared with Advair 100/50 in the target population.
Conditions
Asthma
Being tested
Fluticasone / Salmeterol, Placebo, Advair Diskus 100/50
Medical subject headings
Asthma

What participants receive

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

  • Fluticasone / SalmeterolDrug

    Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura LOMI inhaler device

  • PlaceboDrug

  • Advair Diskus 100/50Drug

    Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)

Study groups in NCT02649478
Study groupRoleWhat they receive
Fluticasone / SalmeterolExperimentalfluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura lever operated multidose inhaler ("LOMI") inhaler device twice a day by inhalation throughout the study
Receives: Drug: Fluticasone / Salmeterol
Advair Diskus 100/50Active comparatorAdvair Diskus (fluticasone propionate and salmeterol xinafoate) twice a day by inhalation throughout the study
Receives: Drug: Advair Diskus 100/50
placebo inhalerPlacebo comparatorplacebo inhaled powder twice a day by inhalation throughout the study
Receives: Drug: Placebo

What is being measured

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

  1. Baseline-adjusted area under the serial FEV1-time curve from time 0 to 12 hours on the first day of the Treatment Period

    Measured: 0-12 hours after dosing on Day 1

  2. Baseline-adjusted, pre-dose FEV1 on the last day of the Treatment Period

    Measured: 30 Days

Secondary outcomes (1)

  1. Adverse Events

    Measured: From Visit 1 (Day -28) until 30 days after the last dose of study drug

Timeline

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

  1. First posted7 Jan 2016 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2015
  4. Study completionNov 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649478
Sponsor's protocol ID
FLSA-P100/50-PVCL-1
Status last verified
Jan 2018
First submitted
5 Jan 2016
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Fluticasone / Salmeterol and Advair Diskus 100/50 in people with Asthma, run by Roxane Laboratories at 100 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 17 inclusion and 14 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Baseline-adjusted area under the serial FEV1-time curve from time 0 to 12 hours on the first day of the Treatment Period (time frame: 0-12 hours after dosing on Day 1). The study lists 2 primary outcomes in all. 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 NCT02649478.

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 23 Jan 2018.

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