Asthma
Conditions
Brief summary
The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects on airway constriction by means of methacholine challenge testing.
Interventions
45/4.5 two puffs twice daily
80/4.5 two puffs twice daily
Sponsors
National Jewish Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma \> 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with \< 10 pk year who stopped \> 1 year ago
Exclusion criteria
* Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and 2. Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event). Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for \>/= 30 days within the 24 months prior to Visit 1. Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for \< 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion. History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator. Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer. Women with a positive urine pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in PC20 | A baseline methacholine challenge was compared to the methacholine challenge performed after 4 weeks of treatment for each arm. | Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRohit K Katial, M.D.
National Jewish Health
Participant flow
Recruitment details
20 subjects males or females 18-65 years of age with physician diagnosed asthma \>12 months will be enrolled in a cross over design using Advair 250 1 bid or Symbicort 80 2 bid. Baseline percent FEV1 \>50% and ≤80%, positive MC or 12% reversibility in the previous 12 months, currently symptomatic with ACT score \<19 at the end of run in, ICS ≥200 and ≤1000 ug/day, non-smoker or ex-smoker with \<10 pk year who stopped \>1 year ago, and bronchodilator response at Visit 1 or 2.
Pre-assignment details
All subjects will enter a 14 day run-in and will be given Fluticasone propionate 88 mcg BID for 14 days. Subjects will capture their PIKO BID with 3 efforts every morning and 3 efforts every night.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
None listed