Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

NCT01117116 | Completed Results

• 1 other identifier: GSK LABA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  A baseline methacholine challenge was compared to the methacholine challenge performed after 4 weeks of treatment for each arm.

Study Arms (2)

fluticasone propionate and salmeterol

ACTIVE COMPARATOR

Drug: fluticasone propionate and salmeterol; Drug: budesonide and formoterol

budesonide and formoterol

ACTIVE COMPARATOR

Drug: fluticasone propionate and salmeterol; Drug: budesonide and formoterol

Interventions

fluticasone propionate and salmeterol DRUG

45/4.5 two puffs twice daily

Also known as: Advair

budesonide and formoterol; fluticasone propionate and salmeterol

budesonide and formoterol DRUG

80/4.5 two puffs twice daily

Also known as: Symbicort

budesonide and formoterol; fluticasone propionate and salmeterol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Pregnanes

Limitations and Caveats

Forced expiratory volume in 1 second (FEV1) was not collected as an independent spirometric assessment. These measurements were intrinsically tied to the administration of the methacholine challenge. Consequently, the FEV1 data were neither captured nor analyzed outside the calculation of the provocative concentration threshold PC20. This limits the ability to evaluate standalone baseline shifts or isolated spirometric variability independently from the challenge.

Results Point of Contact

• Title: Rohit Katial
• Organization: National Jewish Health

katialr@njhealth.org

3033981165

Study Officials

• Rohit K Katial, M.D.

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 6, 2026
• Results First Posted: July 6, 2026

Record last verified: 2026-06

Locations

US (1)