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| ID | Type | Description | Link |
|---|---|---|---|
| 1U10HL098115 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone then Tiotropium then Placebo | Experimental | Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo |
|
| Mometasone then Placebo then Tiotropium | Experimental | Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD |
|
| Placebo then Mometasone then Tiotropium | Experimental | Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD |
|
| Placebo then Tiotropium then Mometasone | Experimental | Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID |
|
| Tiotropium then Placebo then Mometasone | Experimental | Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone 220mcg BID | Drug | Mometasone is an ICS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. | 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 treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, 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. | End of 12-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure | Treatment Failure includes:
|
Not provided
Inclusion Criteria:
Physician-diagnosed asthma for at least previous 12 months.
Able to perform reproducible spirometry.
Baseline FEV1≥70% of predicted.
Asthma confirmed either by:
At least 1 of the following indications for chronic controller therapy:
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.
Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
Exclusion Criteria:
Chronic inhaled or oral corticosteroid therapy.
Use of inhaled or oral corticosteroid therapy within 6 weeks.
New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
Use of omalizumab within 3 months.
History of:
Respiratory tract infection within past 6 weeks.
History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of age, or > 5 pack-years total if < 18 years of age.
Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
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| Name | Affiliation | Role |
|---|---|---|
| William Busse, M.D. | University of Wisconsin, Madison | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine | Tucson | Arizona | 85724 | United States | ||
| UCSF Benioff Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38097180 | Derived | Covar R, Lazarus SC, Krishnan JA, Blake KV, Sorkness CA, Dyer AM, Lang JE, Lugogo NL, Mauger DT, Wechsler ME, Wenzel SE, Cardet JC, Castro M, Israel E, Phipatanakul W, King TS; National Heart, Lung, and Blood Institute AsthmaNet. Association of Sputum Eosinophilia With Easily Measured Type-2 Inflammatory Biomarkers in Untreated Mild Persistent Asthma. J Allergy Clin Immunol Pract. 2024 Apr;12(4):960-969.e6. doi: 10.1016/j.jaip.2023.12.010. Epub 2023 Dec 12. | |
| 31112384 |
| Label | URL |
|---|---|
| AsthmaNet | View source |
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Then Tiotropium Then Placebo | Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| FG001 | Mometasone Then Placebo Then Tiotropium |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tiotropium then Mometasone then Placebo | Experimental | Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo |
|
|
| Tiotropium Respimat 5mcg QD | Drug | Tiotropium is a LMA |
|
| Placebo | Drug |
|
| End of 12-week treatment period |
| Annualized Asthma Control Days | Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365. | End of 12-week treatment period |
| Forced Expiratory Volume at One Second (FEV1) Percent of Predicted | FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height. | End of 12-week treatment period |
| Peak Expiratory Flow Rate | Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. | End of 12-week treatment period |
| Asthma Exacerbations | Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following:
| End of 12-week treatment period |
| San Francisco |
| California |
| 94143 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Clinic | Orlando | Florida | 32827 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Ann and Robert H. Lurie Children's Hospital | Chicago | Illinois | 60614 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27110 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Rainbow Babies and Children's Hospital, Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
| Lazarus SC, Krishnan JA, King TS, Lang JE, Blake KV, Covar R, Lugogo N, Wenzel S, Chinchilli VM, Mauger DT, Dyer AM, Boushey HA, Fahy JV, Woodruff PG, Bacharier LB, Cabana MD, Cardet JC, Castro M, Chmiel J, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Hastie A, Holguin F, Israel E, Jackson D, Kraft M, LaForce C, Lemanske RF Jr, Martinez FD, Moore W, Morgan WJ, Moy JN, Myers R, Peters SP, Phipatanakul W, Pongracic JA, Que L, Ross K, Smith L, Szefler SJ, Wechsler ME, Sorkness CA; National Heart, Lung, and Blood Institute AsthmaNet. Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level. N Engl J Med. 2019 May 23;380(21):2009-2019. doi: 10.1056/NEJMoa1814917. Epub 2019 May 19. |
| 30593883 | Derived | Sorkness CA, King TS, Dyer AM, Chinchilli VM, Mauger DT, Krishnan JA, Blake K, Castro M, Covar R, Israel E, Kraft M, Lang JE, Lugogo N, Peters SP, Wechsler ME, Wenzel SE, Lazarus SC; National Heart Lung and Blood Institute's "AsthmaNet". Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era. Contemp Clin Trials. 2019 Feb;77:98-103. doi: 10.1016/j.cct.2018.12.012. Epub 2018 Dec 27. |
Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| FG002 | Placebo Then Mometasone Then Tiotropium | Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| FG003 | Placebo Then Tiotropium Then Mometasone | Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| FG004 | Tiotropium Then Placebo Then Mometasone | Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| FG005 | Tiotropium Then Mometasone Then Placebo | Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| Completed 1st Period |
|
| Completed 2nd Period |
|
| Completed 3rd Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Then Tiotropium Then Placebo | Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| BG001 | Mometasone Then Placebo Then Tiotropium | Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| BG002 | Placebo Then Mometasone Then Tiotropium | Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| BG003 | Placebo Then Tiotropium Then Mometasone | Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| BG004 | Tiotropium Then Placebo Then Mometasone | Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| BG005 | Tiotropium Then Mometasone Then Placebo | Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Forced expiratory volume at one second (FEV1) Percent of Predicted | FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height. | Mean | Standard Deviation | percentage of predicted FEV1 |
| ||||||||||||||
| Asthma Control Test | Measure Description: Asthma Control Test: The score is calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Sputum differential count - Percent eosinophils | Percentage of cells collected from induced sputum that are eosinophils | Median | Inter-Quartile Range | percentage of cells |
| ||||||||||||||
| Blood differential count - Percent eosinophils | Percentage of blood cells that are eosinophils | Median | Inter-Quartile Range | percentage of cells |
|
| 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 | Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. | 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 treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, 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. | For each pairwise comparison (mometasone vs. placebo and tiotropium vs. placebo), participants were required to complete both of the relevant treatment periods in order to be included in the analysis. | Posted | Count of Participants | Participants | End of 12-week treatment period |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Failure | Treatment Failure includes:
| participants who completed the treatment period with data to evaluate treatment failure outcome | Posted | Count of Participants | Participants | End of 12-week treatment period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Asthma Control Days | Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365. | participants who completed the treatment period with data to evaluate asthma control days | Posted | Mean | Standard Deviation | days | End of 12-week treatment period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume at One Second (FEV1) Percent of Predicted | FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height. | participants who completed the treatment period and were able to provide FEV1 measurements | Posted | Mean | Standard Deviation | percentage of predicted FEV1 | End of 12-week treatment period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Expiratory Flow Rate | Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. | participants who completed the treatment period and were able to provide FEV1 measurements | Posted | Mean | Standard Deviation | liters per minute | End of 12-week treatment period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Asthma Exacerbations | Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following:
| participants who completed the treatment period with data to evaluate exacerbations | Posted | Count of Participants | Participants | End of 12-week treatment period |
|
|
Each participant was followed over the course of three 12-week treatment periods for a total of 36 weeks. The adverse events recorded below are reported at the treatment period level and represent 12 weeks of "at risk" exposure time.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The placebo treatment period for all participants | 0 | 276 | 0 | 276 | 45 | 276 |
| EG001 | Mometasone 220mcg BID | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | 0 | 275 | 6 | 275 | 47 | 275 |
| EG002 | Tiotropium Respimat 5mcg QD | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD | 0 | 271 | 2 | 271 | 38 | 271 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pregnancy | Pregnancy, puerperium and perinatal conditions | ICD-9 | Non-systematic Assessment |
| |
| closed fracture of lower end of humerus | Musculoskeletal and connective tissue disorders | ICD-9 | Non-systematic Assessment |
| |
| Partial bowel obstruction. | Gastrointestinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-9 | Non-systematic Assessment |
| |
| Unspecified nonpsychotic mental disorder | Psychiatric disorders | ICS-9 | Non-systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | ICD-9 | Non-systematic Assessment |
| |
| malignant neoplasm of skin of other and unspecified parts of face | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-9 | Non-systematic Assessment |
| |
| Acute appendicitis without mention of peritonitis | Gastrointestinal disorders | ICD-9 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute nasopharyngitis | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
| |
| Acute URI not otherwise specified | Respiratory, thoracic and mediastinal disorders | ICD-9 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Mauger | Penn State University | 717-531-7178 | dmauger@psu.edu |
| Mar 26, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Placebo superior to mometasone |
|
|
| Mometesone equal to placebo |
|
|
| Tiotropium superior to placebo |
|
|
| Placebo superior to tiotropium |
|
|
| Tiotropium equal to placebo |
|
|
| The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025. | exact binomial test | 0.029 | a priori threshold for significance was 0.025 | Superiority |
| The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations. | exact binomial test | 0.001 | this analysis is considered exploratory | Superiority |
| The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations. | exact binomial test | 0.45 | this analysis is considered exploratory | Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Participants |
|
|