AsthmaARGARGNCT00521222
Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes
A study testing Fluticasone with salmeterol, Fluticasone HFA and Ipratropium HFA in people with Asthma, run by Columbia University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone with salmeterol, Fluticasone HFA and Ipratropium HFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Columbia University Medical Center Eastside
New York, New York, 10022
Columbia Presbyterian Medical Center
New York, New York, 10032
About this study
Official title: Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.
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.
Read more
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.
Read the detailed description
Beta 2 (b2) agonists are the most common type of bronchodilator used to treat asthma. Beta 2 (b2) agonists are agents that bind to b2 receptors and cause muscle relaxation of the airways. There are different variants of the gene (genotypes) that influence how b2 agonists perform among the population.
A recent study demonstrated that patients with mild asthma and the Arg/Arg variant at the 16th amino acid position have improved lung function and asthma control when albuterol (Proventil-HFA), a short acting b2 agonist, is replaced with a different class of bronchodilator. The investigators plan to study asthma patients with distinct genetic makeups of the b2 receptor; specifically Arg/Arg and Gly/Gly.
Throughout the treatment period, patients will be instructed to use ipratropium bromide (Atrovent-HFA), a bronchodilator which works through a different mechanism for rescue therapy; albuterol will be available for use if necessary.
The goal of this study is to determine if the withdrawal of a beta 2 agonist leads to improved asthma control in those asthmatic patients with the Arg/Arg genotype compared with those with the Gly/Gly genotype.
- Conditions
- Asthma
- Being tested
- Fluticasone with salmeterol, Fluticasone HFA, Ipratropium HFA, Albuterol HFA
- Keywords
- asthma, beta agonist, bronchodilator, pulmonary, genotype, pharmacogenomics, corticosteroid, allergy, immunology
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone with salmeterolDrug
Also called Advair HFA
Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.
Fluticasone HFADrug
Also called Flovent HFA
Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Ipratropium HFADrug
Also called Atrovent
Primary as-needed rescue medication in all treatment groups
Albuterol HFADrug
Secondary as-needed rescue medication in all treatment groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Fluticasone HFA; Drug: Ipratropium HFA; Drug: Albuterol HFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 16 weeks from baseline
Secondary outcomes (4)
Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator
Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator as measured by spirometry
Measured: Up to 16 weeks from baseline
Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator
Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator as measured by spirometry
Measured: Up to 16 weeks from baseline
Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator
Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator as measured by spirometry
Measured: Up to 16 weeks from baseline
Change in Asthma Symptom Score
Asthma symptom score measures asthma symptoms on a scale from 0 to 3. 0 = No asthma symptoms; 1 = 1-3 asthma episodes each lasting 2 hours or less, all mild; 2= 4 or more asthma episodes that interfered with activity, play, school, or sleep for less than 2 hours; 3= 1 or more asthma episodes lasting longer than 2 hours, or resulting in shortening normal activity, or seeing a doctor, or going to a hospital. A higher score indicates a worse outcome.
Measured: Up to 16 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjorie Slankard, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521222
- Sponsor's protocol ID
- AAAC1135
- Acronym
- ARGARG
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2007
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.
- ClinicalTrials.gov ID
- NCT00521222
- Acronym / sponsor ID
- ARGARG / AAAC1135
- Conditions
- Asthma
- Keywords
- asthma, beta agonist, bronchodilator, pulmonary, genotype, pharmacogenomics, corticosteroid, allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Beta 2 (b2) agonists are the most common type of bronchodilator used to treat asthma. Beta 2 (b2) agonists are agents that bind to b2 receptors and cause muscle relaxation of the airways. There are different variants of the gene (genotypes) that influence how b2 agonists perform among the population.
A recent study demonstrated that patients with mild asthma and the Arg/Arg variant at the 16th amino acid position have improved lung function and asthma control when albuterol (Proventil-HFA), a short acting b2 agonist, is replaced with a different class of bronchodilator. The investigators plan to study asthma patients with distinct genetic makeups of the b2 receptor; specifically Arg/Arg and Gly/Gly.
Throughout the treatment period, patients will be instructed to use ipratropium bromide (Atrovent-HFA), a bronchodilator which works through a different mechanism for rescue therapy; albuterol will be available for use if necessary.
The goal of this study is to determine if the withdrawal of a beta 2 agonist leads to improved asthma control in those asthmatic patients with the Arg/Arg genotype compared with those with the Gly/Gly genotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA | Active comparator | Drug: Fluticasone with salmeterol, Drug: Ipratropium HFA, Drug: Albuterol HFAAsthma 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. |
| Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA | Active comparator | Drug: Fluticasone with salmeterol, Drug: Ipratropium HFA, Drug: Albuterol HFAAsthma 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. |
| Arg/Arg genotype on Fluticasone HFA | Experimental | Drug: Fluticasone HFA, Drug: Ipratropium HFA, Drug: Albuterol HFAAsthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone. |
| Gly/Gly genotype on Fluticasone HFA | Experimental | Drug: Fluticasone HFA, Drug: Ipratropium HFA, Drug: Albuterol HFAAsthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone with salmeterolAlso: Advair HFAFluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. | Drug | Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA, Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA |
| Fluticasone HFAAlso: Flovent HFAFluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. | Drug | Arg/Arg genotype on Fluticasone HFA, Gly/Gly genotype on Fluticasone HFA |
| Ipratropium HFAAlso: AtroventPrimary as-needed rescue medication in all treatment groups | Drug | 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 HFASecondary as-needed rescue medication in all treatment groups | Drug | 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 |
Primary outcome
Absolute Change in Morning Peak Flow
Time frame: Up to 16 weeks from baseline
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.
4 secondary outcomes
Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator
Time frame: Up to 16 weeks from baseline
Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator
Time frame: Up to 16 weeks from baseline
Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator
Time frame: Up to 16 weeks from baseline
Change in Asthma Symptom Score
Time frame: Up to 16 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie Slankard, M.D. principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluticasone with salmeterol, Fluticasone HFA and Ipratropium HFA in people with Asthma, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Morning Peak Flow (time frame: Up to 16 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.