Asthma
Conditions
Keywords
Asthma, Fluticasone, Salmeterol
Brief summary
The purpose of this study is to find the best asthma treatment to add for Blacks who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if Black adults and children differ in how they respond to the medications used in this study.
Detailed description
BARD is a 66 week prospective, randomized, double-blind, crossover trial in Blacks (individuals who self-report Black ancestry) who have inadequately controlled asthma while taking low-dose inhaled corticosteroids (ICS). BARD will examine the efficacy of increasing the dose of ICS with or without the addition of a long-acting beta agonist (LABA) to determine whether individual patients respond better to one treatment than another and, if so, whether the responses are different for children and adults or if they are related to genetic ancestry.
Interventions
DRUGFlovent Diskus® 100 mcg
Flovent is an ICS
DRUGFlovent Diskus® 250 mcg
Flovent is an ICS
DRUGFlovent Diskus® 500 mcg
Flovent is an ICS
DRUGAdvair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
DRUGAdvair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals who self-report Black ancestry (with at least 1 Black grandparent). 2. Able to perform reproducible spirometry according to ATS criteria. 3. Clinical history consistent with asthma. 4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted. 5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year 6. Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score \<20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20. 7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment. 8. Non-smoker (total lifetime smoking history \< 5 pack-years if \<18, or \<10 pack-years if ≥18 years of age; no smoking for at least 1 year). 9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
Exclusion criteria
1. Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients. 2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment. 3. Unwilling to provide a blood sample for DNA extraction and genetic analysis. 4. Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk. 5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year. 6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years. 7. History of a respiratory tract infection within 4 weeks of enrollment. 8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method. 9. Pregnancy or lactation or planning to get pregnant during the course of the trial. 10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment. 11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | The last 12 weeks of each 14-week treatment period | This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crossover Sequence 1 Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg
Flovent Diskus® 100 mcg: Flovent is an ICS
Flovent Diskus® 250 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 69 |
| Crossover Sequence 2 Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg
Flovent Diskus® 100 mcg: Flovent is an ICS
Flovent Diskus® 250 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 69 |
| Crossover Sequence 3 Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Flovent Diskus® 100 mcg: Flovent is an ICS
Flovent Diskus® 250 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 71 |
| Crossover Sequence 4 Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg
Flovent Diskus® 100 mcg: Flovent is an ICS
Flovent Diskus® 250 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 71 |
| Crossover Sequence 5 Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg
Flovent Diskus® 250 mcg: Flovent is an ICS
Flovent Diskus® 500 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 73 |
| Crossover Sequence 6 Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg
Flovent Diskus® 250 mcg: Flovent is an ICS
Flovent Diskus® 500 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 72 |
| Crossover Sequence 7 Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Flovent Diskus® 250 mcg: Flovent is an ICS
Flovent Diskus® 500 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 75 |
| Crossover Sequence 8 Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg
Flovent Diskus® 250 mcg: Flovent is an ICS
Flovent Diskus® 500 mcg: Flovent is an ICS
Advair Diskus® 100/50 mcg: Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg: Advair is an ICS/LABA combination | 74 |
| Total | 574 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 5 | 3 | 2 | 4 | 8 | 12 | 6 | 8 |
| Overall Study | Physician Decision | 2 | 0 | 2 | 1 | 1 | 1 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 15 | 14 | 10 | 7 | 8 | 9 | 10 | 12 |
Baseline characteristics
| Characteristic | Crossover Sequence 1 | Crossover Sequence 2 | Crossover Sequence 3 | Crossover Sequence 4 | Crossover Sequence 5 | Crossover Sequence 6 | Crossover Sequence 7 | Crossover Sequence 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 8.7 years STANDARD_DEVIATION 2 | 8.5 years STANDARD_DEVIATION 1.7 | 8.4 years STANDARD_DEVIATION 1.9 | 8.4 years STANDARD_DEVIATION 1.8 | 38.5 years STANDARD_DEVIATION 16.5 | 38.5 years STANDARD_DEVIATION 15.9 | 39.3 years STANDARD_DEVIATION 16 | 35.6 years STANDARD_DEVIATION 16 | 23.2 years STANDARD_DEVIATION 18.5 |
| Asthma Control Test | — | — | — | — | 18.9 units on a scale STANDARD_DEVIATION 3.8 | 18.6 units on a scale STANDARD_DEVIATION 3.9 | 19.2 units on a scale STANDARD_DEVIATION 3.7 | 18.8 units on a scale STANDARD_DEVIATION 3.8 | 18.9 units on a scale STANDARD_DEVIATION 3.8 |
| Childhood Asthma Control Test | 21.5 units on a scale STANDARD_DEVIATION 3.7 | 21.2 units on a scale STANDARD_DEVIATION 3.6 | 20.7 units on a scale STANDARD_DEVIATION 4.1 | 22.1 units on a scale STANDARD_DEVIATION 3.6 | — | — | — | — | 21.4 units on a scale STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 7 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 65 Participants | 64 Participants | 65 Participants | 71 Participants | 70 Participants | 73 Participants | 71 Participants | 541 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Forced expiratory volume at one second (FEV1) Percent of Predicted | 98.1 percent STANDARD_DEVIATION 15.4 | 92.6 percent STANDARD_DEVIATION 17.9 | 95 percent STANDARD_DEVIATION 13.6 | 96.2 percent STANDARD_DEVIATION 19.1 | 83.8 percent STANDARD_DEVIATION 19.1 | 82.9 percent STANDARD_DEVIATION 15.5 | 83.7 percent STANDARD_DEVIATION 17.3 | 83.4 percent STANDARD_DEVIATION 18 | 89.3 percent STANDARD_DEVIATION 18.1 |
| Race/Ethnicity, Customized Black | 63 Participants | 65 Participants | 68 Participants | 66 Participants | 69 Participants | 71 Participants | 74 Participants | 73 Participants | 549 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 25 Participants |
| Region of Enrollment United States | 69 participants | 69 participants | 71 participants | 71 participants | 73 participants | 72 participants | 75 participants | 74 participants | 574 participants |
| Sex: Female, Male Female | 29 Participants | 27 Participants | 26 Participants | 28 Participants | 52 Participants | 48 Participants | 47 Participants | 52 Participants | 309 Participants |
| Sex: Female, Male Male | 40 Participants | 42 Participants | 45 Participants | 43 Participants | 21 Participants | 24 Participants | 28 Participants | 22 Participants | 265 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 280 | 0 / 280 | 0 / 280 | 0 / 280 | 0 / 294 | 0 / 294 | 0 / 294 | 0 / 294 |
| other Total, other adverse events | 64 / 280 | 52 / 280 | 43 / 280 | 27 / 280 | 53 / 294 | 47 / 294 | 35 / 294 | 34 / 294 |
| serious Total, serious adverse events | 8 / 280 | 1 / 280 | 2 / 280 | 4 / 280 | 10 / 294 | 7 / 294 | 7 / 294 | 8 / 294 |
Outcome results
Primary
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Time frame: The last 12 weeks of each 14-week treatment period
Population: Not all treatments were used in all participants. Flovent 500 was not used in children and Flovent 100 was not used in adolescents and adults
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 250/50 superior to Flovent 250 | .46 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 inferior to Flovent 250 | .28 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 250/50 inferior to Flovent 250 | .33 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 inferior to Advair 250/50 | .36 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 250/50 superior to Flovent 500 | .49 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 250/50 inferior to Flovent 500 | .31 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Flovent 500 superior to Flovent 250 | .35 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Flovent 500 inferior to Flovent 250 | .40 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 superior to Flovent 500 | .53 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 superior to Flovent 250 | .49 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 inferior to Flovent 500 | .27 probability |
| Adolescents and Adults | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 superior to Advair 250/50 | .42 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Flovent 250 inferior to Flovent 100 | .37 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 superior to Flovent 250 | .46 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 inferior to Flovent 250 | .46 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 superior to Advair 250/50 | .47 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 inferior to Advair 250/50 | .49 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 superior to Flovent 100 | .53 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 100/50 inferior to Flovent 100 | .41 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 250/50 superior to Flovent 250 | .43 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Advair 250/50 inferior to Flovent 250 | .47 probability |
| Children | The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. | Flovent 250 superior to Flovent 100 | .51 probability |
Comparison: Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250p-value: 0.003Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250p-value: 0.9Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500p-value: <0.001Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50p-value: 0.42Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50p-value: 0.84Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500p-value: 0.015Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250p-value: 0.085Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250p-value: 0.62Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250p-value: 0.48Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100p-value: 0.14Mixed Models Analysis
Comparison: Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100p-value: 0.096Mixed Models Analysis