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

NCT00385463 | Withdrawn

• 1 other identifier: GSK ADA103575
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Asthma; Seasonal Allergic Rhinitis

Keywords

Asthma; Rhinitis; Allergic Asthma

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (2)

• 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

Interventions

Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID DRUG

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent is obtained.
• Male or female
• Years and older
• Diagnosis of persistent asthma for at least three months.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic, Seasonal; Rhinitis

Interventions

BID protein, human; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections

Study Officials

• Robert Townley, M.D.

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 9, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

US (1)