Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00385463 |
Recruitment Status :
Withdrawn
First Posted : October 9, 2006
Last Update Posted : June 16, 2016
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The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration (FDA) and are currently available by prescription at your drug store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and one is for treatment of both SAR and asthma. In addition, you will also receive one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may experience throughout the study.
The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma Seasonal Allergic Rhinitis | Drug: Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Versus Montelukast in Adolescents/Adults With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus(R) or Placebo |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

- Mean change from baseline at endpoint in morning PEF compared between fluticasone propionate/salmeterol combination product 100/50mcg BID (FSC) and montelukast 10mg QD (MON) treatment groups.
- Assess superiority and compare between FSC and FSC+MON treatment groups
- Assess equivalence.
- Rhinitis mean change from baseline in subject-rated: daily, total nasal symptom scores averaged over Weeks 1-2 and nighttime total nasal symptom scores averaged over Weeks 1-2.
- Asthma assess superiority and assess equivalence: mean change from baseline at endpoint in predose AM FEV1; percentage of asthma rescue-free days; and percentage of asthma rescue-free days

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Signed and dated written informed consent is obtained.
- Male or female
- 15 Years and older
- Diagnosis of persistent asthma for at least three months.
- 3 months prior and current use of specified asthma therapies
- FEV1 between 65-95% of predicted value
- Diagnosis of seasonal allergic rhinitis
- Active residence within geographical regions where exposure to relevant seasonal allergic is expected
Exclusion Criteria:
- Currently diagnosed with life-threatening asthma
- Asthma instability
- Concurrent respiratory disease
- Nasal obstruction
- Nasal history
- Certain concurrent conditions/diseases
- Drug allergy
- Respiratory tract infections
- Specific (listed in protocol) concurrent medications
- Systemic corticosteroids

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385463
United States, Nebraska | |
Creighton University | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Robert Townley, M.D. | Creighton University |
Responsible Party: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00385463 |
Other Study ID Numbers: |
GSK ADA103575 |
First Posted: | October 9, 2006 Key Record Dates |
Last Update Posted: | June 16, 2016 |
Last Verified: | June 2016 |
Asthma Rhinitis Allergic Asthma |
Asthma Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Montelukast Fluticasone-Salmeterol Drug Combination Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Glucocorticoids |