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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluticasone propionate and salmeterol | Active Comparator |
| |
| budesonide and formoterol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate and salmeterol | Drug | 45/4.5 two puffs twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Rohit K Katial, M.D. | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
All subjects will enter a 14 day run-in and will be given Fluticasone propionate 88 mcg BID for 14 days. Subjects will capture their PIKO BID with 3 efforts every morning and 3 efforts every night.
20 subjects males or females 18-65 years of age with physician diagnosed asthma >12 months will be enrolled in a cross over design using Advair 250 1 bid or Symbicort 80 2 bid. Baseline percent FEV1 >50% and ≤80%, positive MC or 12% reversibility in the previous 12 months, currently symptomatic with ACT score <19 at the end of run in, ICS ≥200 and ≤1000 ug/day, non-smoker or ex-smoker with <10 pk year who stopped >1 year ago, and bronchodilator response at Visit 1 or 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Propionate and Salmeterol | All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take fluticasone propionate and salmeterol 45/21mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm budesonide and formoterol in a cross over manner. Subjects will begin period 2 and will take budesonide and formoterol 80/4.5 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit. |
| FG001 | Budesonide and Formoterol | All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take budesonide and formoterol 80/4.5 mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm fluticasone propionate and salmeterol in a cross over manner. Subjects will begin period 2 and will take fluticasone propionate and salmeterol 45/21 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Propionate and Salmeterol | All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take fluticasone propionate and salmeterol 45/21mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm budesonide and formoterol in a cross over manner. Subjects will begin period 2 and will begin taking budesonide and formoterol 80/4.5 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | It was a crossover | Posted | Least Squares Mean | 95% Confidence Interval | PC20 mg/ml | A baseline methacholine challenge was compared to the methacholine challenge performed after 4 weeks of treatment for each arm. |
|
Adverse Events were collected from screening to end of treatment visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Propionate | 88 mcg BID for 14 day Run-in period | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rohit Katial | National Jewish Health | 3033981165 | katialr@njhealth.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| budesonide and formoterol | Drug | 80/4.5 two puffs twice daily |
|
|
| NOT COMPLETED |
|
| BG001 | Budesonide and Formoterol | All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take budesonide and formoterol 80/4.5 mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm fluticasone propionate and salmeterol in a cross over manner. Subjects will begin period 2 and will begin taking fluticasone propionate and salmeterol 45/21 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit.ily |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Fluticasone Propionate and Salmeterol | 45/21mcg 2 puffs BID for 28 days per intervention | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Budesonide and Formoterol | 80/4.5 mcg 2 puffs BID per intervention | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |