A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma

NCT00452348 | Completed Phase 4 Results

• 1 other identifier: ADA109057
• Study Type: interventional
• Target: 628
• Locations: 5 countries
• Sites: 81

Brief Summary

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Conditions

Asthma

Keywords

FLOVENT; fluticasone; 12 month; salmeterol; asthma; ADVAIR

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52

  Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.

  Baseline and Week 1 through Week 52

Secondary Outcomes (3)

• Mean Change From Baseline in AM PEF Over Weeks 1-52

  Baseline and Week 1 through Week 52

• Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52

  Baseline and Week 1 through Week 52

• Rate of Asthma Attacks Per Participant Per Year

  Week 1 through Week 52

Study Arms (2)

Fluticasone propionate 250 mcg BID

ACTIVE COMPARATOR

Fluticasone propionate 250 mcg BID

Drug: Fluticasone propionate 250 mcg BID

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

ACTIVE COMPARATOR

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Drug: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Interventions

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID DRUG

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Also known as: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Fluticasone propionate 250 mcg BID DRUG

Fluticasone propionate 250 mcg BID

Fluticasone propionate 250 mcg BID

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:

• Subjects eligible for enrollment in the study must meet all of the following criteria:
• Consent: A signed and dated written informed consent must be obtained from the subject and/or subject's legally acceptable representative prior to study participation.
• Type of Subject: Outpatient
• Gender: Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating.
• A female is eligible to enter and participate in the study if she is:
• of non-child-bearing potential; OR
• of child-bearing potential but has a negative urinary pregnancy test at Screening (Visit 1 and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study.
• Acceptable methods of contraception \[Hatcher, 2004\] are:
• \- Abstinence
• oral contraceptive (either combined or progestogen only)
• injectable progestogen
• implants of levonorgestrel
• estrogenic vaginal ring
• percutaneous contraceptive devices
• intrauterine device (IUD) or intrauterine system (IUS) with published data showing that the lowest expected failure rate is less than 1% per year

You may not qualify if:

• Subjects meeting any of the following criteria must not be enrolled in the study:
• Life-Threatening Asthma: A subject must not have life-threatening asthma. Life-threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening (Visit 1).
• Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an ER visit, hospitalization or use of oral/parenteral corticosteroids within 4 weeks of screening (Visit 1).
• Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study.
• Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
• Concurrent Conditions/Diseases: A subject with historical or current evidence of any clinically significant, co-morbid or uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
• The list of excluded conditions/diseases includes, but is not limited to:
• congestive heart failure known aortic aneurysm clinically significant coronary clinically significant cardiac arrhythmia heart disease stroke within 3 months of screening (Visit 1) uncontrolled hypertension coronary artery disease hematologic, hepatic, or renal disease cystic fibrosis poorly controlled peptic ulcer dyspnea by any other cause than asthma gastroesophageal reflux disease (GERD) not controlled by pharmacotherapy and may be causing/contributing to subject's respiratory symptoms thyrotoxicosis hypokalemia immunologic compromise current malignancy1 tuberculosis (current or quiescent) Cushing's or Addison's disease pneumonia, pneumothorax, chronic bronchitis or atelectasis uncontrolled diabetes mellitus recent history of drug or alcohol abuse 1.history of malignancy is acceptable only if subject has been in remission for one year prior to screening (Visit 1; remission = no treatment for the malignancy in the 12 months prior to screening \[Visit 1\])
• Drug Allergy: A subject must not have had any immediate or delayed hypersensitivity to any beta2-agonist; sympathomimetic drug; any intranasal; inhaled or systemic corticosteroid therapy; lactose; or have a severe milk protein allergy.
• Respiratory Tract Infections: A subject must not have had any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection symptoms that have not resolved at least 7 days immediately preceding screening (Visit 1).
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• Concurrent Medications: A subject must not have the concurrent use of any of the following medications that interact with any of the study drugs used in this study, or that may affect the course of asthma or interact with sympathomimetic amines, such as:
• \- beta-adrenergic receptor blocking agents
• \- monoamine oxidase (MAO) inhibitors
• \- tricyclic antidepressants

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (81)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Mobile, Alabama, 36608, United States

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GSK Investigational Site

Fresno, California, 93720, United States

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GSK Investigational Site

Fullerton, California, 92835, United States

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GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

Long Beach, California, 90808, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

San Diego, California, 92120, United States

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GSK Investigational Site

Stockton, California, 95207, United States

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GSK Investigational Site

Vista, California, 92083, United States

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Pueblo, Colorado, 81008, United States

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Hudson, Florida, 34667, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33613, United States

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Albany, Georgia, 31707, United States

Location

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Gainesville, Georgia, 30501, United States

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Lawrenceville, Georgia, 30045, United States

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Savannah, Georgia, 31406, United States

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Coeur d'Alene, Idaho, 83814, United States

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Evansville, Indiana, 47710, United States

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Owensboro, Kentucky, 42301, United States

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Sunset, Louisiana, 70584, United States

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Rochester, Minnesota, 55905, United States

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Chesterfield, Missouri, 63017, United States

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Jefferson City, Missouri, 65101, United States

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Missoula, Montana, 59808, United States

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Lincoln, Nebraska, 68505, United States

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GSK Investigational Site

Papillion, Nebraska, 68046, United States

Location

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Ocean City, New Jersey, 07712, United States

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New York, New York, 10016, United States

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Charlotte, North Carolina, 28207, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Canton, Ohio, 44718, United States

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Oklahoma City, Oklahoma, 73120, United States

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Lake Oswego, Oregon, 97035, United States

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Medford, Oregon, 97504, United States

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Collegeville, Pennsylvania, 19426, United States

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Erie, Pennsylvania, 16508, United States

Location

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Philadelphia, Pennsylvania, 19102, United States

Location

GSK Investigational Site

Cumberland, Rhode Island, 02864, United States

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GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

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Greenville, South Carolina, 29615, United States

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Greer, South Carolina, 29651, United States

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El Paso, Texas, 79903, United States

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GSK Investigational Site

Houston, Texas, 77070, United States

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GSK Investigational Site

Killeen, Texas, 76542, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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Waco, Texas, 76712, United States

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Murray, Utah, 84107, United States

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GSK Investigational Site

Norfolk, Virginia, 23507, United States

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GSK Investigational Site

Gig Harbor, Washington, 98335, United States

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GSK Investigational Site

Tacoma, Washington, 98405, United States

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GSK Investigational Site

Morgantown, West Virginia, 26505, United States

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GSK Investigational Site

Greenfield, Wisconsin, 53228, United States

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Madison, Wisconsin, 53972, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

GSK Investigational Site

Buenos Aires, Buenos Aires, 1221, Argentina

Location

GSK Investigational Site

Buenos Aires, Buenos Aires, 1437, Argentina

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GSK Investigational Site

Mendoza, Mendoza Province, M5500CCG, Argentina

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GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

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GSK Investigational Site

Santa Fe, Santa Fe Province, 3000, Argentina

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GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

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GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

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GSK Investigational Site

Rio de Janeiro, Rio de Janeiro, 20221-903, Brazil

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GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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GSK Investigational Site

Florianópolis, Santa Catarina, Brazil

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GSK Investigational Site

Santo André, São Paulo, 09060-670, Brazil

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GSK Investigational Site

São Paulo, São Paulo, 04079002, Brazil

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GSK Investigational Site

Vancouver, British Columbia, V5Z 1K3, Canada

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GSK Investigational Site

Moncton, New Brunswick, E1C 2Z3, Canada

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GSK Investigational Site

Kitchener, Ontario, N2C 2N9, Canada

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GSK Investigational Site

Newmarket, Ontario, L3Y 5G8, Canada

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GSK Investigational Site

Oshawa, Ontario, L1H 7K4, Canada

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GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

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GSK Investigational Site

Saint Romuald, Quebec, G6W 5M6, Canada

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GSK Investigational Site

Saint-Léonard, Quebec, H1S 3A9, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, G1W 4R4, Canada

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GSK Investigational Site

Quezon City, 1101, Philippines

Location

GSK Investigational Site

Quezon City, 1109, Philippines

Location

Related Publications (2)

• Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.

  PMID: 23706709 BACKGROUND

• Kerwin E, Prazma CM, Sutton L, Stempel DA. Safety and efficacy of long-term treatment with fluticasone propionate and salmeterol via DISKUS versus fluticasone propionate alone. Clin Res Reg Aff 2011;28(1):14-21.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; BID protein, human

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 9, 2016
• Results First Posted: February 15, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (5); CA (9); US (58); AR (7); PH (2)