Asthma
Conditions
Keywords
Rhinovirus, Asthma
Brief summary
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.
Interventions
comparator
DRUGfluticasone propionate
Comparator
DRUGplacebo
Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 | Days 1 through 4 | The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 | Days 1 through 4 | PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed. |
| Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4 | Days 1 through 4 | FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed. |
| Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4 | Days 1 through 4 | eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed. |
Countries
United States
Participant flow
Pre-assignment details
Eligible subjects were randomized to one of two sputum induction groups (sputum induction, no sputum induction) and then stratified at a second randomization to one of three treatment groups (Fluticasone Propionate/Salmeterol \[FSC 250/50\] mcg twice a day \[BID\], Fluticasone Propionate \[FP\] 250 mcg BID, or Placebo BID).
Participants by arm
| Arm | Count |
|---|---|
| FSC 250/50 mcg BID Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily | 5 |
| FP 250 mcg BID Fluticasone Propionate (FP) (250 microgram) twice daily | 5 |
| Placebo Diskus BID Placebo twice daily | 6 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | FSC 250/50 mcg BID | FP 250 mcg BID | Placebo Diskus BID | Total |
|---|---|---|---|---|
| Age, Continuous | 20.4 years STANDARD_DEVIATION 2.07 | 20.0 years STANDARD_DEVIATION 1 | 23.0 years STANDARD_DEVIATION 5.83 | 21.25 years STANDARD_DEVIATION 3.8 |
| Gender Female | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Gender Male | 5 Participants | 3 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 0 participants | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native/Native Hawaiian/Pac | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 5 participants | 2 participants | 4 participants | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 5 | 1 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 6 |
Outcome results
Primary
Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4
The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.
Time frame: Days 1 through 4
Secondary
Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4
eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.
Time frame: Days 1 through 4
Secondary
Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4
FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.
Time frame: Days 1 through 4
Secondary
Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4
PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.
Time frame: Days 1 through 4