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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

Page last updated: August 23, 2015

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