Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Asthma Clinical Trial

Official title:

Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117116
• Other study ID #: GSK LABA
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: September 2013

Study information

• Verified date: January 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Hypersensitivity

Intervention

Drug:
• fluticasone propionate and salmeterol
45/4.5 two puffs twice daily
• budesonide and formoterol
80/4.5 two puffs twice daily

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in PC20	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.	Study Completion
Secondary	Changes in FEV1	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).	Study Completion