Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: fluticasone propionate and salmeterol; Drug: budesonide and formoterol

• Registration Number: NCT01117116
• Lead Sponsor: National Jewish Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
budesonide and formoterol	fluticasone propionate and salmeterol	-
fluticasone propionate and salmeterol	budesonide and formoterol	-
fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	-
budesonide and formoterol	budesonide and formoterol	-

Primary Outcome Measures

Name	Time	Method
Improvement in PC20	Study Completion	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.

Secondary Outcome Measures

Name	Time	Method
Changes in FEV1	Study Completion	Changes in peak pre-bronchodilator FEV1 \[measured at hours 10, 11, 12 post evening dose\] over the four week treatment periods and over each 12 hour dosing period (pre evening dose FEV1).

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States