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AzTrials

AsthmaPhase 4NCT00296491

Study Of Allergic Rhinitis In Patients Who Also Have Asthma

A Phase 4 study testing fluticasone propionate/salmeterol (FSC), montelukast (MON) and fluticasone propionate (FP) in people with Asthma, run by GlaxoSmithKline at 121 sites in 4 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 study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Asthma
What is being tested?
fluticasone propionate/salmeterol (FSC), montelukast (MON) and fluticasone propionate (FP)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
725 participants
Where
121 sitesin 4 countries
Study dates
Sep 2005to Oct 2007
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
  • Consent: A signed and dated written informed consent must be obtained from the subject or subject's legally acceptable representative prior to study participation. An informed consent must be signed prior to any change in the subject's medication regimen, including withholding medications prior to Visit 1.
  • Gender: Male or female. Females are eligible to participate only if they are currently not pregnant and not lactating. Females of child-bearing potential will be required to use a highly effective method for avoiding pregnancy (i.e., contraception with a failure rate of <1% per year). Female subjects of child-bearing potential will undergo a urine pregnancy test at Visits 1, 2, 3, and 4. Any female who becomes pregnant during the study will be withdrawn. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
  • Age: 15 years and older.
  • Asthma Diagnosis: A diagnosis of persistent asthma, for at least three months, as defined by the following American Thoracic Society definition:
  • Asthma is a clinical syndrome characterized by increased responsiveness of the tracheobronchial tree to a variety of stimuli. The major symptoms of asthma are paroxysms 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, 1987a].
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  • NOTE: Intermittent and seasonal asthma, as well as exercise-induced bronchospasm alone, are excluded.
  • Asthma Therapy: 3 months' prior and current use of one of the following asthma therapies, with no change in regimen during the month prior to Visit 1:
  • Scheduled or as-needed inhaled or oral short-acting beta2-agonist (SABA). Subjects must be able to replace their current short-acting beta2-agonist with albuterol/salbutamol, to be used only on an as-needed basis for the duration of the study.
  • Allowed non-corticosteroid controller therapy (e.g., anticholinergics and cromolyn).
  • One of the following inhaled corticosteroids taken at the corresponding daily dose:
  • criteria.
  • Inhaled Corticosteroid (Total Daily Dose) Beclomethasone dipropionate (≤420mcg) Beclomethasone dipropionate HFA (≤240mcg) Budesonide (≤400mcg) Flunisolide (≤1000mcg) Fluticasone propionate inhalation aerosol (≤220mcg) Fluticasone propionate inhalation powder (≤250mcg) Mometasone furoate (≤220mcg) Triamcinolone acetonide (≤1000mcg) Subjects taking ADVAIR 100/50mcg BID are eligible to replace ADVAIR with FLOVENT HFA 110mcg BID for 14 days prior to Visit 1. This change will be at the Investigator's clinical discretion, taking each individual's current and past asthma stability into account. The subject must be aware of the risks and benefits of switching their medication and acknowledge this by signing an informed consent prior to any change in the subject's medication regimen.
  • Asthma Severity: An FEV1 between 65% - 95% of predicted value at Visit 1 after withholding asthma medications as detailed in the protocol.
  • At Visit 2, subjects must also be experiencing minimum asthma symptoms as defined in Section 5.2.3, "Randomization Criteria", and in Section 6.2 of the protocol.
  • Predicted FEV1 will be based on the National Health and Nutrition Examination Survey (NHANES III) predicted normal values [Hankinson, 1999].
  • Rhinitis Diagnosis: A diagnosis of seasonal allergic rhinitis defined as follows:
  • A clinical history (written or verbal confirmation) of allergic rhinitis with the seasonal onset and offset of nasal allergy symptoms during each of the previous 2 relevant allergy seasons (captured in source documents only).
  • AND •A positive skin test reaction to a geographically relevant seasonal allergen, as determined by the skin prick method, within 24 months prior to or at Visit 1.
  • For the purposes of this study, a positive skin test reaction is defined as a wheal diameter that is at least 3mm greater than diluent control using 1:20 W:V glycerinated solution.
  • •At Visit 2, subjects must also be experiencing minimum rhinitis symptoms as defined in Section 5.2.3, "Randomization Criteria", and in Section 6.2 of the protocol.
  • Geographical Location: Active residence within a geographical region where exposure to a relevant seasonal allergen is expected to be significant during the entire study period.
  • Note: The principal investigator is responsible for tracking and recording pollen counts for geographically relevant seasonal allergens throughout the entire study. Alternatively, this information may be obtained from a reputable source from within the same geographical area.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Currently Diagnosed with Life-Threatening Asthma: An episode or episodes of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • Asthma Instability: Hospitalization for asthma within 6 months of Visit 1.
  • Concurrent Respiratory Disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, or any other respiratory abnormalities other than asthma.
  • Nasal Obstruction: Severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug.
  • Nasal History: History of nasal septal perforation or recent nasal septal surgery.
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  • Other Concurrent Conditions/Diseases: Any evidence of rhinitis medicamentosa, history of glaucoma and/or cataracts or ocular herpes simplex, or any clinically significant, 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 additional excluded conditions/diseases includes, but is not limited to: cardiac arrhythmias; congestive heart failure; coronary artery disease; poorly controlled diabetes, poorly controlled hypertension, poorly controlled peptic ulcer, hematologic, hepatic, or renal disease; immunologic compromise; current malignancy; current or quiescent tuberculosis, and Cushing's or Addison's disease.
  • Drug Allergy: Any immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, leukotriene modifier, or any intranasal, inhaled, or systemic corticosteroid therapy, or sensitivity to aspirin or other NSAIDS. Subjects with severe milk protein allergies are also excluded from participation.
  • Respiratory Tract Infections: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 14 days immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 14 days prior to Visit 1.
  • Concurrent Medications: Concurrent use of any of the following medications that may affect the course of asthma, rhinitis, or interact with sympathomimetic amines or montelukast.
  • Beta-blockers
  • tricyclic antidepressants
  • monoamine oxidase inhibitors
  • phenobarbital
  • rifampin
  • ritonavir
  • ketoconazole
  • Systemic Corticosteroids: Use of oral or parenteral systemic corticosteroids within 28 days of Visit 1, or requirement for more than two courses of parenteral systemic corticosteroids for asthma within 6 months of Visit 1.
  • NOTE: Topical hydrocortisone cream or ointment (1% or less) is permitted during the study.
  • Excluded Rhinitis Medications: The following rhinitis medications must be withheld during the corresponding "exclusion period" prior to Visit 1 and are not allowed any time during the study, unless dispensed as double-blind study drug:
  • Medication (Exclusion Period Prior to Visit 1) Intranasal and ocular corticosteroids (28 days) Leukotriene modifiers (e.g., Singulair, Accolate, Zyflo) (28 days) Intranasal and ocular cromolyn (14 days) Long-acting antihistamines (e.g., loratadine, cetirizine) (10 days) Short-acting antihistamines (includes prescription and OTC) (72 hours) Oral and intranasal decongestants (72 hours) Intranasal anticholinergics (e.g., Atrovent) (24 hours)
  • Excluded Asthma Medications: The following asthma medications must be withheld during the corresponding "exclusion period" prior to Visit 1.
  • These asthma medications, with the exception of an inhaled corticosteroid/long-acting beta2-agonist combination product and Xolair, may be continued during the run-in period of the study (between Visits 1 and 2), but must be withheld prior to Visit 2 for the appropriate "exclusion period" as shown below.
  • These asthma medications are not allowed any time after randomization at Visit 2 (with the exception of as as-needed rescue albuterol/salbutamol), unless dispensed as double-blind study drug:
  • Medicationª (Exclusion Period Prior to Visit 1 and/or Visit 2) Inhaled corticosteroid/long-acting beta2-agonist combination product (e.g., ADVAIR) (14 days) Inhaled anticholinergics (e.g., Atrovent, Combivent, Spiriva) (24 hours) Theophylline products (48 hours) Inhaled cromolyn or nedocromil (24 hours) Inhaled corticosteroids (12 hours) Long-acting beta2-agonists (e.g., Foradil, SEREVENT™) (14 days) Oral beta2-agonists (12 hours) Inhaled short-acting beta2-agonists^b (e.g., Proventil) (6 hours) Xolair (12 months)
  • For the leukotriene modifier "exclusion period" prior to Visit 1, refer to Exclusion Criterion 11.
  • Replaced at Visit 1 with albuterol/salbutamol.
  • Ophthalmic preparations: Use of artificial tears, eyewashes, homeopathic preparations, irrigation solutions, lubricants, sympathomimetic preparations, vasoconstrictors, or combinations of any of the aforementioned products during the study.
  • Immunosuppressive Medications: Use of immunosuppressive medications during the study.
  • NOTE: Immunotherapy for the treatment of allergies is allowed during the study, provided that it was not initiated within 30 days of Visit 1, the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
  • Positive Pregnancy Test: A positive pregnancy test at Visit 1.
  • Tobacco Use: Greater than a 10 pack-year history of cigarette smoking or use of any tobacco products within 1 year of Visit 1. This includes cigarettes, cigars, pipe, chewing tobacco, and snuff.
  • Note: Pack years = number of cigarettes smoked per day divided by 20, multiplied by the number of years of smoking.
  • Questionable Validity of Consent: Any infirmity or disability that would limit the subject's consent or geographic location that would limit the compliance for scheduled visits.
  • Investigational Medications: Use of any investigational drug within 30 days of Visit 1.
  • 3rd shift/Nighttime employment: Any employment during the nighttime hours (10 p.m. - 6 a.m.) or 3rd shift.
  • Site affiliation: Participation of anyone associated with the administration of the study or their immediate family members

Trial locations and contacts

121 sites in 4 countries.

121 sites in 4 countries

United States104 sites

  • GSK Investigational Site

    Albany, Georgia, 31707

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austin, Texas, 78750

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70808

  • GSK Investigational Site

    Bend, Oregon, 97701

  • GSK Investigational Site

    Berkeley, California, 94705

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Boulder, Colorado, 80304

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Charleston, South Carolina, 29414

  • GSK Investigational Site

    Chattanooga, Tennessee, 37421

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75231-4307

  • GSK Investigational Site

    Dallas, Texas, 75240

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Danville, Virginia, 24541

  • GSK Investigational Site

    El Paso, Texas, 79902

  • GSK Investigational Site

    El Paso, Texas, 79925

  • GSK Investigational Site

    Forked River, New Jersey, 08731

  • GSK Investigational Site

    Fort Collins, Colorado, 80526

  • GSK Investigational Site

    Gainesville, Georgia, 30501

  • GSK Investigational Site

    Germantown, Tennessee, 38138

  • GSK Investigational Site

    Glendale, Arizona, 85304

  • GSK Investigational Site

    Greenville, South Carolina, 29607

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Houston, Texas, 77054

  • GSK Investigational Site

    Houston, Texas, 77070

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Indianapolis, Indiana, 46208

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jefferson City, Missouri, 65101

  • GSK Investigational Site

    Kerrville, Texas, 78028

  • GSK Investigational Site

    Kirkland, Washington, 98034

  • GSK Investigational Site

    Knoxville, Tennessee, 37909

  • GSK Investigational Site

    Lafayette, Louisiana, 70503

  • GSK Investigational Site

    Lakewood, Colorado, 80401

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Louisville, Kentucky, 40215

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    North Andover, Massachusetts, 01845

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Omaha, Nebraska, 68130

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Overland Park, Kansas, 66210

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Papillion, Nebraska, 68046

  • GSK Investigational Site

    Parma, Ohio, 44129

  • GSK Investigational Site

    Pensacola, Florida, 32504

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    Providence, Rhode Island, 02906

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Richmond, Virginia, 23298

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rochester, New York, 14618

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    Roseville, California, 95678

  • GSK Investigational Site

    Salt Lake City, Utah, 84121

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78233

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Jose, California, 95117

  • GSK Investigational Site

    San Jose, California, 95128

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    Savannah, Tennessee, 38372

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Shreveport, Louisiana, 71105

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    South Bend, Indiana, 46617

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Springfield, Illinois, 62704

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stockton, California, 95207

  • GSK Investigational Site

    Summit, New Jersey, 07091

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Upland, Pennsylvania, 19013

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Waco, Texas, 76708

  • GSK Investigational Site

    Warrensburg, Missouri, 64093

  • GSK Investigational Site

    West Jordan, Utah, 84084

Other trials in United States

Canada11 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Kanata, Ontario, K2L 3C8

  • GSK Investigational Site

    Mississauga, Ontario, L5A 3V4

  • GSK Investigational Site

    Niagara Falls, Ontario, L2G 1J4

  • GSK Investigational Site

    Ottawa, Ontario, K1N 6N5

  • GSK Investigational Site

    Ottawa, Ontario, K2C 3R2

  • GSK Investigational Site

    Québec, Quebec, G1V 4M6

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Poland4 sites

  • GSK Investigational Site

    Bialystok, 15-025

  • GSK Investigational Site

    Bialystok, 15-274

  • GSK Investigational Site

    Krakow, 31-023

  • GSK Investigational Site

    Lodz, 93-513

Other trials in Poland

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Read the detailed description

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Conditions
Asthma
Being tested
fluticasone propionate/salmeterol (FSC), montelukast (MON), fluticasone propionate (FP), placebo nasal, ADVAIR DISKUS
Keywords
Allergic Rhinitis, Asthma
Medical subject headings
Asthma, Rhinitis, Allergic

What participants receive

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

  • fluticasone propionate/salmeterol (FSC)Drug

    fluticasone propionate/salmeterol DISKUS combination

  • montelukast (MON)Drug

    montelukast capsule

  • fluticasone propionate (FP)Drug

    fluticasone propionate aqueous nasal spray

  • placebo nasalDrug

    vehicle placebo nasal spray

  • ADVAIR DISKUSDrug

    ADVAIR DISKUS

  • placebo capsuleDrug

    placebo capsule

  • placebo DISKUSDrug

    placebo DISKUS

Study groups in NCT00296491
Study groupRoleWhat they receive
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)Active comparatorFluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
Receives: Drug: fluticasone propionate/salmeterol (FSC); Drug: montelukast (MON); Drug: placebo nasal; Drug: ADVAIR DISKUS
Fluticasone Propionate/Salmeterol (FSC)Active comparatorFSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Receives: Drug: fluticasone propionate/salmeterol (FSC); Drug: placebo nasal; Drug: ADVAIR DISKUS; Drug: placebo capsule
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)Active comparatorFluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
Receives: Drug: fluticasone propionate/salmeterol (FSC); Drug: fluticasone propionate (FP); Drug: ADVAIR DISKUS; Drug: placebo capsule
Montelukast (MON)Active comparatorPlacebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Receives: Drug: montelukast (MON); Drug: placebo nasal; Drug: placebo DISKUS

What is being measured

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

  1. Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population

    Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.

    Measured: Baseline to Endpoint (weeks 3-4)

  2. Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population

    Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.

    Measured: Baseline to Endpoint (weeks 3-4)

Secondary outcomes (8)

  1. Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).

    The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)

    Measured: Baseline to 1-2 Weeks

  2. Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)

    The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.

    Measured: Baseline To 1-2 Weeks

  3. Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population

    Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.

    Measured: Baseline to Endpoint (weeks 3-4)

  4. Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population

    Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.

    Measured: Baseline to Endpoint (weeks 3-4)

  5. Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population

    Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.

    Measured: Baseline to Endpoint (weeks 3-4)

  6. Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population

    Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied

    Measured: Baseline to Endpoint (weeks 3-4)

  7. Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population

    Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).

    Measured: Baseline to Endpoint (weeks 3-4)

  8. Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population

    Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).

    Measured: Baseline to Endpoint (weeks 3-4)

Timeline

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

  1. First posted27 Feb 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionOct 2007
  4. Study completionOct 2007

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
Double blind
Who is masked
Participant, Investigator
Enrolment
725 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00296491
Sponsor's protocol ID
ADA103575
Status last verified
Nov 2016
First submitted
23 Feb 2006
Last updated
16 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

  • Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan-Feb;31(1):68-75. doi: 10.2500/aap.2010.31.3306.

    PubMed 20167147

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fluticasone propionate/salmeterol (FSC), montelukast (MON) and fluticasone propionate (FP) in people with Asthma, run by GlaxoSmithKline at 121 sites in 4 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 23 inclusion and 38 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 16 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 121 sites in United States, Canada, Poland, Estonia. 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 13 May 2009). 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 at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (time frame: Baseline to Endpoint (weeks 3-4)). 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 NCT00296491, which also lists 1 linked publication.

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 16 Dec 2016.

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