Study Of RV-39 In Patients Who Also Have Asthma

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 4

Conditions: Asthma

Treatments: Drug: fluticasone propionate/salmeterol; Drug: fluticasone propionate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503009

HZA109895

Details and patient eligibility

About

This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have asthma for at least 3 months prior to the study.
• Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
• Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.
• Have a positive allergic status antibody test.

Exclusion criteria

• Have a history of life-threatening asthma.
• Been hospitalized for asthma within the 24 months prior to the study.
• Have certain conditions that would make study participation unsafe.
• The study doctor will evaluate other inclusion and exclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 3 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: fluticasone propionate/salmeterol

Arm 2

Active Comparator group

Treatment:

Drug: fluticasone propionate

Arm 3

Placebo Comparator group

Treatment:

Drug: placebo