Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Sponsor

National Jewish Health (Other)

Overall Status

Completed

CT.gov ID

NCT01117116

Collaborator

(none)

Enrollment

Location

Arms

42.1

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: fluticasone propionate and salmeterol Drug: budesonide and formoterol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: fluticasone propionate and salmeterol	Drug: fluticasone propionate and salmeterol 45/4.5 two puffs twice daily Other Names: Advair Drug: budesonide and formoterol 80/4.5 two puffs twice daily Other Names: Symbicort
Active Comparator: budesonide and formoterol	Drug: fluticasone propionate and salmeterol 45/4.5 two puffs twice daily Other Names: Advair Drug: budesonide and formoterol 80/4.5 two puffs twice daily Other Names: Symbicort

Arm

Intervention/Treatment

Active Comparator: fluticasone propionate and salmeterol

Drug: fluticasone propionate and salmeterol

45/4.5 two puffs twice daily

Other Names:

Advair

Drug: budesonide and formoterol

80/4.5 two puffs twice daily

Other Names:

Symbicort

Active Comparator: budesonide and formoterol

Drug: fluticasone propionate and salmeterol

45/4.5 two puffs twice daily

Other Names:

Advair

Drug: budesonide and formoterol

80/4.5 two puffs twice daily

Other Names:

Symbicort

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.