Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Information source: National Jewish Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate and salmeterol (Drug); budesonide and formoterol (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Jewish Health Official(s) and/or principal investigator(s): Rohit K Katial, M.D., Principal Investigator, Affiliation: National Jewish Health
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.
Clinical Details
Official title: Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Improvement in PC20
Secondary outcome: Changes in FEV1
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
National Jewish Health, Denver, Colorado 80206, United States
Additional Information
Starting date: March 2010
Last updated: April 14, 2015
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