Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes

NCT00521222 | Completed Results DMC

• 1 other identifier: AAAC1135
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators are conducting a study of asthma patients who use fluticasone with salmeterol (Advair) or any other combination of an inhaled corticosteroid (ICS) and a long acting beta agonist (LABA) to manage their asthma symptoms. Participants begin the study by continuing to use fluticasone with salmeterol or substituting fluticasone with salmeterol for their current ICS/LABA medication at their regular dose or the comparable dose(all study medications are provided) for a six-week period. Patients are then separated into 2 groups: one group is asked to use fluticasone (Flovent), the other to use fluticasone with salmeterol , twice daily over a 16-week period (patients will need to be seen monthly during this time). Neither study personnel nor patients will know which drug is being used. Patients are also asked to use a peak flow meter and record their daily results on a form, along with the number of puffs they use of their rescue inhaler each day. They also record any changes in asthma medications and information on any asthma episodes. The investigators hypothesize that there are certain patients with asthma who will do better when a long acting beta agonist is removed from their maintenance asthma medications.

Conditions

Asthma

Keywords

asthma; beta agonist; bronchodilator; pulmonary; genotype; pharmacogenomics; corticosteroid; allergy; immunology

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Morning Peak Flow

  Absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). Peak flow measurement is a test to measure air flowing out of the lung.

  Up to 16 weeks from baseline

Secondary Outcomes (4)

• Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator

  Up to 16 weeks from baseline

• Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator

  Up to 16 weeks from baseline

• Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator

  Up to 16 weeks from baseline

• Change in Asthma Symptom Score

  Up to 16 weeks from baseline

Study Arms (4)

Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA

ACTIVE COMPARATOR

Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.

Drug: Fluticasone with salmeterol; Drug: Ipratropium HFA; Drug: Albuterol HFA

Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA

ACTIVE COMPARATOR

Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.

Drug: Fluticasone with salmeterol; Drug: Ipratropium HFA; Drug: Albuterol HFA

Arg/Arg genotype on Fluticasone HFA

EXPERIMENTAL

Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.

Drug: Fluticasone HFA; Drug: Ipratropium HFA; Drug: Albuterol HFA

Gly/Gly genotype on Fluticasone HFA

EXPERIMENTAL

Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.

Drug: Fluticasone HFA; Drug: Ipratropium HFA; Drug: Albuterol HFA

Interventions

Fluticasone with salmeterol DRUG

Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.

Also known as: Advair HFA

Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA; Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA

Fluticasone HFA DRUG

Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.

Also known as: Flovent HFA

Arg/Arg genotype on Fluticasone HFA; Gly/Gly genotype on Fluticasone HFA

Ipratropium HFA DRUG

Primary as-needed rescue medication in all treatment groups

Also known as: Atrovent

Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA; Arg/Arg genotype on Fluticasone HFA; Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA; Gly/Gly genotype on Fluticasone HFA

Albuterol HFA DRUG

Secondary as-needed rescue medication in all treatment groups

Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA; Arg/Arg genotype on Fluticasone HFA; Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA; Gly/Gly genotype on Fluticasone HFA

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• History of moderate or severe and persistent asthma
• Currently being treated with a long acting beta agonist and inhaled corticosteroid
• Forced expiratory volume at one second (FEV1) \> or = 70% at randomization visit (pulmonary function test result)
• Women of childbearing potential must be on an effective form of contraception
• Ability to read and understand English

You may not qualify if:

• Active smoking or greater than 10-pack-year history of smoking
• History of intubation for asthma within the past 10 years
• Patients who are pregnant, become pregnant during the study or are breast feeding
• Major comorbidity including: severe cardiac disease, uncontrolled hypertension, poorly controlled diabetes, malignancy within the past 5 years (except non-melanoma skin lesions), and pulmonary disease other than asthma

Sponsors & Collaborators

• Columbia University: lead

Study Sites (3)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Columbia University Medical Center Eastside

New York, New York, 10022, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity

Interventions

Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Marjorie Slankard, MD
• Organization: Columbia University Irving Medical Center

ms53@columbia.edu

212-326-8410

Study Officials

• Marjorie Slankard, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Locations

US (3)