Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo

• Status: Withdrawn
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Creighton University
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Montelukast

Criteria

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