Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Jewish Health
Sponsor:
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT01117116
First received: May 3, 2010
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention
Asthma
Drug: fluticasone propionate and salmeterol
Drug: budesonide and formoterol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Improvement in PC20 [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
    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 [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Advair Drug: budesonide and formoterol
80/4.5 two puffs twice daily
Other Name: Symbicort
Active Comparator: Symbicort Drug: fluticasone propionate and salmeterol
45/4.5 two puffs twice daily
Other Name: Advair

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117116

Contacts
Contact: Nina Thompson 303-398-1911 thompsonn@njhealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Principal Investigator: Rohit Katial, MD         
Sponsors and Collaborators
National Jewish Health
Investigators
Principal Investigator: Rohit K Katial, M.D. National Jewish Health
  More Information

No publications provided

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT01117116     History of Changes
Other Study ID Numbers: GSK LABA
Study First Received: May 3, 2010
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Budesonide
Formoterol
Salmeterol
Fluticasone
Symbicort
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on August 20, 2014