Asthma
Conditions
Keywords
Asthma, Asthma Control
Brief summary
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.
Detailed description
This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).
Interventions
DRUGfluticasone
fluticasone (100 microgram twice daily) treatment
DRUGmontelukast
Montelukast (5 or 10 mg each night).
DRUGFluticasone plus salmeterol
fluticasone (100 microgram) plus salmeterol (50 microgram) each night
Sponsors
GlaxoSmithKline
JHSPH Center for Clinical Trials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* physician-diagnosed asthma * age 6 or older * pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted * beta-agonist reversibility OR airways hyperreactivity by methacholine challenge * Juniper Asthma Control Score of 1.5 or greater if not on daily controller * good current health
Exclusion criteria
* current or past smoking (greater than 20 pack-years) * chronic or current oral steroid therapy * pregnancy, lack of effective contraception (when appropriate), lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | 16 weeks | The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night | 169 |
| Montelukast Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night | 166 |
| Fluticasone Plus Salmeterol Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night | 165 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Fluticasone | Montelukast | Fluticasone Plus Salmeterol | Total |
|---|---|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 14.6 | 32.4 years STANDARD_DEVIATION 15.4 | 30.8 years STANDARD_DEVIATION 14.9 | 30.8 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 103 Participants | 95 Participants | 103 Participants | 301 Participants |
| Sex: Female, Male Male | 66 Participants | 71 Participants | 62 Participants | 199 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 | 159 / 168 | 156 / 165 | 157 / 162 |
| serious Total, serious adverse events | 6 / 168 | 4 / 165 | 4 / 162 |
Outcome results
Primary
Treatment Failure
The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluticasone | Treatment Failure | 34 participants |
| Montelukast | Treatment Failure | 50 participants |
| Fluticasone Plus Salmeterol | Treatment Failure | 33 participants |