Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01117116

Run by

National Jewish Health

People needed

20

Starts

2010-03-01

Expected to finish

2013-09-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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