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AzTrials

AsthmaPhase 4NCT00452348

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

A Phase 4 study testing Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID in people with Asthma, run by GlaxoSmithKline at 81 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial 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. 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 Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID
Could I receive a placebo?
No, everyone receives an active treatment
How many people
628 participants
Where
81 sitesin 5 countries
Study dates
May 2007to Apr 2009
Phase
Phase 4
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

  • 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
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  • 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
  • male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject
  • double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent
  • Age: A subject must be 12 years of age at Visit 1 (screening).
  • Asthma Diagnosis: A documented diagnosis of persistent asthma, for at least six months, as defined by the following American Thoracic Society definition:
  • Asthma is a clinical syndrome characterized by increased responsiveness of the airways to a variety of stimuli. The major symptoms of asthma are episodes of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe and unremitting (status asthmaticus). The primary physiological manifestation of this hyperresponsiveness is variable airway obstruction. This can take the form of spontaneous fluctuations in the severity of obstruction, substantial improvements in the severity of obstruction following bronchodilators or corticosteroids, or increased obstruction caused by drugs or other stimuli [American Thoracic Society, 1987].
  • Asthma Medication History: A subject must be using a low to medium dose of an ICS (Table 1) OR a combination of controller medications (Table 2), containing a low (total daily) dose ICS (as defined in Table 1) for at least 4 weeks preceding screening.
  • Table 1 (ICS Dosage Table) Inhaled Corticosteroid (Dosage (mcg/day))(LowMedium) Beclomethasone dipropionate CFC (168 = 504> 504 = 840) Beclomethasone dipropionate HFA (80 = 240>240 = 640) Triamcinolone acetonide (400 = 1000>1000 = 2000) Flunisolide (500 = 1000> 1000 = 2000) Fluticasone propionate inhalation aerosol (176 = 220> 220 = 440) Fluticasone propionate inhalation powder (100 = 250> 250 = 500) Budesonide1 (200 = 600> 600 =1200) Mometasone (200 = 400> 400 = 800) Ciclesonide (80 = 160>160 = 320)
  • 1.Respules are allowed at a dosage of 250-500mcg/day.
  • Table 2 (Asthma Controller Medications) Asthma Controller Medication(s) Low dose ICS + Leukotriene modifiers Low dose ICS + Theophylline products Low Dose ICS + Inhaled anticholinergics or combination products (e.g., Atrovent or Combivent) Low Dose ICS + Long acting inhaled anticholinergic (e.g. Spiriva) Low dose ICS+ long acting beta agonist or combination products containing a low dose ICS and a long-acting beta-agonists (e.g. ADVAIR™/SERETIDE™1 100/50 mcg BID or Symbicort 160/9 mcg BID (i.e 80/4.5 mcg two inhalations BID)
  • 1.ADVAIR/SERETIDE =250/50 mcg BID or Symbicort 320/9 mcg BID (i.e 160/4.5 mcg two inhalation BID) are not permitted.
  • Pulmonary function: A pre-albuterol (salbutamol) FEV1 of 50% and 85% of predicted normal value at screening (Visit 1) after withholding asthma medications as detailed in the protocol (Section 6.8.1). Predicted FEV1 will be based on the National Health and Nutrition Examination Survey (NHANES III) predicted normal values for ages 8 years and older [Hankinson, 1999].
  • Reversibility: An increase in FEV1 of 12% over the pre-albuterol (salbutamol) FEV1 within 30 minutes after the inhalation of 2-4 puffs of albuterol (salbutamol). Historical documentation of reversibility will not be permitted.
  • Asthma symptom criteria: Each subject must have experienced asthma symptoms requiring albuterol (salbutamol) use within the 4 weeks preceding screening (Visit 1).
  • Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the IB and the product labels.

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • 1.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).
  • 2.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).
  • 3.Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study.
  • 4.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.
  • 5.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.
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  • 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).
  • Asthma Medications: Asthma medications listed below must not have been used prior to screening (Visit 1) for the required exclusion period as indicated below:
  • Medication (Exclusion Period Prior to screening (Visit 1)) Oral or parenteral systemic corticosteroids (4 weeks) Omalizumab (Xolair) (6 months)
  • <!-- -->
  • 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
  • ritonavir
  • ketoconazole
  • Concurrent use of asthma medications: Concurrent use of all asthma medications (other than protocol defined study and rescue medications and oral/parenteral corticosteroids) are prohibited during the study.
  • Concomitant use of leukotriene modifiers (LTM) for allergies is prohibited. A subject must not be on LTM for treatment of nasal allergies that requires regular maintenance therapy. Substitution with any other antihistamine is permitted.
  • Immunosuppressive Medications: A subject must not be using, or require the use of, immunosuppressive medications during the study.
  • Immunotherapy for the treatment of allergies is not allowed during the study unless the subject has used a constant dose for 4 weeks prior to Screening (Visit 1) and the same dose will be continued throughout the study.
  • Tobacco Use: >10 pack year history or use of any tobacco products within 1 year of screening (Visit 1). This includes cigarettes, cigars, pipe, chewing tobacco, and snuff.
  • Questionable Validity of Consent: A subject must not have any infirmity or disability that would limit the subject's consent.
  • Positive Pregnancy Test (for all females who have had menarche): A current positive pregnancy test.
  • Investigational Medications: A subject must not have had use of any investigational drug within 30 days of screening (Visit 1).
  • Site Affiliation: A subject may not participate if he/she is a participating investigator, sub-investigator, study coordinator, employee of a participating investigator or is in any way associated with the administration of the study. Immediate family members of these individuals are also excluded.
  • Compliance with Study Requirements: A subject may not participate if, in the opinion of the investigator, there are present or anticipated circumstances that will prohibit the subject from being compliant with study visits and procedures (e.g. geographic location that will prohibit subject from required clinic visit schedule).

Trial locations and contacts

81 sites in 5 countries.

81 sites in 5 countries

United States58 sites

  • GSK Investigational Site

    Albany, Georgia, 31707

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Collegeville, Pennsylvania, 19426

  • GSK Investigational Site

    Cumberland, Rhode Island, 02864

  • GSK Investigational Site

    El Paso, Texas, 79903

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Evansville, Indiana, 47710

  • GSK Investigational Site

    Fargo, North Dakota, 58104

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Gainesville, Georgia, 30501

  • GSK Investigational Site

    Gig Harbor, Washington, 98335

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Houston, Texas, 77070

  • GSK Investigational Site

    Hudson, Florida, 34667

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Jefferson City, Missouri, 65101

  • GSK Investigational Site

    Killeen, Texas, 76542

  • GSK Investigational Site

    Lake Oswego, Oregon, 97035

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Madison, Wisconsin, 53972

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    Murray, Utah, 84107

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    Ocean City, New Jersey, 07712

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Papillion, Nebraska, 68046

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19102

  • GSK Investigational Site

    Pueblo, Colorado, 81008

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    South Miami, Florida, 33143

  • GSK Investigational Site

    Stockton, California, 95207

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada9 sites

  • GSK Investigational Site

    Kitchener, Ontario, N2C 2N9

  • GSK Investigational Site

    Moncton, New Brunswick, E1C 2Z3

  • GSK Investigational Site

    Newmarket, Ontario, L3Y 5G8

  • GSK Investigational Site

    Oshawa, Ontario, L1H 7K4

  • GSK Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • GSK Investigational Site

    Saint-Léonard, Quebec, H1S 3A9

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1W 4R4

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B4

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1K3

Other trials in Canada

Argentina7 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1221

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1437

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Mendoza, Mendoza Province, M5500CCG

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    Santa Fe, Santa Fe Province, 3000

Other trials in Argentina

Brazil5 sites

  • GSK Investigational Site

    Florianópolis, Santa Catarina

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • GSK Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20221-903

  • GSK Investigational Site

    Santo André, São Paulo, 09060-670

  • GSK Investigational Site

    São Paulo, São Paulo, 04079002

Other trials in Brazil

Philippines2 sites

  • GSK Investigational Site

    Quezon City, 1101

  • GSK Investigational Site

    Quezon City, 1109

Other trials in Philippines

About this study

Official title: A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects With Asthma

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
Being tested
Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID, Fluticasone propionate 250 mcg BID
Keywords
FLOVENT, fluticasone, 12 month, salmeterol, asthma, ADVAIR
Medical subject headings
Asthma

What participants receive

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

  • Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BIDDrug

    Also called 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 BIDDrug

    Fluticasone propionate 250 mcg BID

Study groups in NCT00452348
Study groupRoleWhat they receive
Fluticasone propionate 250 mcg BIDActive comparatorFluticasone propionate 250 mcg BID
Receives: Drug: Fluticasone propionate 250 mcg BID
Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BIDActive comparatorFluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
Receives: Drug: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

What is being measured

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

  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.

    Measured: Baseline and Week 1 through Week 52

Secondary outcomes (3)

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

    Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.

    Measured: Baseline and Week 1 through Week 52

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

    A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.

    Measured: Baseline and Week 1 through Week 52

  3. Rate of Asthma Attacks Per Participant Per Year

    The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a >=20% decrease in AM PEF, a >=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.

    Measured: Week 1 through Week 52

Timeline

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

  1. First posted27 Mar 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452348
Sponsor's protocol ID
ADA109057
Status last verified
Oct 2016
First submitted
26 Mar 2007
Last updated
9 Dec 2016
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 23706709

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID in people with Asthma, run by GlaxoSmithKline at 81 sites in 5 countries.

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 29 inclusion and 29 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Canada, Argentina, Brazil, Philippines. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Feb 2010). 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?

Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52 (time frame: Baseline and Week 1 through Week 52). 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 NCT00452348, which also lists 2 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 Dec 2016.

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