An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

NCT ID: NCT00528996

Last Updated: 2021-08-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-06

Study Completion Date

2009-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution

BEA 2180 BR low dose

Low dose

Group Type EXPERIMENTAL

BEA 2180 BR

Intervention Type DRUG

Solution

BEA 2180 BR medium dose

Medium dose

Group Type EXPERIMENTAL

BEA 2180 BR

Intervention Type DRUG

Solution

BEA 2180 BR high dose

High dose

Group Type EXPERIMENTAL

BEA 2180 BR

Intervention Type DRUG

Solution

Tiotropium Bromide

Tiotropium Bromide

Group Type EXPERIMENTAL

Tiotropium Bromide

Intervention Type DRUG

Solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BEA 2180 BR

Solution

Intervention Type DRUG

Tiotropium Bromide

Solution

Intervention Type DRUG

Placebo

Solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:

Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
3. Male or female patients 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

Exclusion Criteria

1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3. Patients with a recent history (one year or less) of myocardial infarction.
4. Patients with any unstable or life-threatening cardiac arrhythmia.
5. Patients who have been hospitalized for heart failure within the past 3 years.
6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
8. Patients with known narrow-angle glaucoma.
9. Patients with asthma or a history of asthma.
10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
11. Patients with known active tuberculosis.
12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1205.14.061 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1205.14.054 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1205.14.042 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

1205.14.017 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Site Status

1205.14.022 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Site Status

1205.14.046 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Site Status

1205.14.008 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1205.14.047 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1205.14.037 Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

Site Status

1205.14.041 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1205.14.027 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

1205.14.034 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1205.14.050 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1205.14.013 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Site Status

1205.14.016 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1205.14.048 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1205.14.043 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

1205.14.040 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1205.14.007 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

1205.14.053 Boehringer Ingelheim Investigational Site

Stockbridge, Georgia, United States

Site Status

1205.14.014 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

1205.14.035 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

Site Status

1205.14.057 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Site Status

1205.14.052 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Site Status

1205.14.036 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

1205.14.019 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Site Status

1205.14.018 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Site Status

1205.14.032 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1205.14.033 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Site Status

1205.14.044 Boehringer Ingelheim Investigational Site

Brick, New Jersey, United States

Site Status

1205.14.056 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

Site Status

1205.14.058 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Site Status

1205.14.010 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1205.14.062 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Site Status

1205.14.028 Boehringer Ingelheim Investigational Site

Mineola, New York, United States

Site Status

1205.14.030 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Site Status

1205.14.021 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1205.14.059 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1205.14.012 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1205.14.031 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

1205.14.003 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1205.14.004 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

1205.14.005 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

Site Status

1205.14.029 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1205.14.055 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1205.14.020 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1205.14.045 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Site Status

1205.14.025 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1205.14.060 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1205.14.002 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1205.14.023 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1205.14.024 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1205.14.026 Boehringer Ingelheim Investigational Site

Roanoke, Virginia, United States

Site Status

1205.14.009 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1205.14.039 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1205.14.001 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Site Status

1205.14.151 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1205.14.144 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1205.14.148 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1205.14.143 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

Site Status

1205.14.142 Boehringer Ingelheim Investigational Site

Downsview, Ontario, Canada

Site Status

1205.14.150 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

Site Status

1205.14.149 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Site Status

1205.14.146 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1205.14.145 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1205.14.381 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1205.14.164 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.167 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.168 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.172 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.175 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.177 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.178 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.377 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.382 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.387 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.388 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1205.14.165 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

1205.14.176 Boehringer Ingelheim Investigational Site

Cottbus, , Germany

Site Status

1205.14.171 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1205.14.379 Boehringer Ingelheim Investigational Site

Geesthacht, , Germany

Site Status

1205.14.174 Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

Site Status

1205.14.173 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1205.14.375 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1205.14.378 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

1205.14.170 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

Site Status

1205.14.162 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1205.14.384 Boehringer Ingelheim Investigational Site

Marburg, , Germany

Site Status

1205.14.166 Boehringer Ingelheim Investigational Site

Minden, , Germany

Site Status

1205.14.372 Boehringer Ingelheim Investigational Site

Neumünster, , Germany

Site Status

1205.14.386 Boehringer Ingelheim Investigational Site

Neuruppin, , Germany

Site Status

1205.14.385 Boehringer Ingelheim Investigational Site

Oschersleben, , Germany

Site Status

1205.14.169 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1205.14.179 Boehringer Ingelheim Investigational Site

Rüsselsheim am Main, , Germany

Site Status

1205.14.376 Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

Site Status

1205.14.374 Boehringer Ingelheim Investigational Site

Schwetzingen, , Germany

Site Status

1205.14.371 Boehringer Ingelheim Investigational Site

Witten, , Germany

Site Status

1205.14.373 Boehringer Ingelheim Investigational Site

Witten, , Germany

Site Status

1205.14.279 Boehringer Ingelheim Investigational Site

Budakeszi, , Hungary

Site Status

1205.14.273 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1205.14.283 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1205.14.287 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1205.14.286 Boehringer Ingelheim Investigational Site

Cegléd, , Hungary

Site Status

1205.14.281 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1205.14.272 Boehringer Ingelheim Investigational Site

Deszk, , Hungary

Site Status

1205.14.289 Boehringer Ingelheim Investigational Site

Deszk, , Hungary

Site Status

1205.14.271 Boehringer Ingelheim Investigational Site

Érd, , Hungary

Site Status

1205.14.276 Boehringer Ingelheim Investigational Site

Gödöllö, , Hungary

Site Status

1205.14.282 Boehringer Ingelheim Investigational Site

Gyula, , Hungary

Site Status

1205.14.277 Boehringer Ingelheim Investigational Site

Komárom, , Hungary

Site Status

1205.14.278 Boehringer Ingelheim Investigational Site

Mátraháza, , Hungary

Site Status

1205.14.280 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, , Hungary

Site Status

1205.14.285 Boehringer Ingelheim Investigational Site

Sopron, , Hungary

Site Status

1205.14.275 Boehringer Ingelheim Investigational Site

Szarvas, , Hungary

Site Status

1205.14.288 Boehringer Ingelheim Investigational Site

Százhalombatta, , Hungary

Site Status

1205.14.284 Boehringer Ingelheim Investigational Site

Tatabánya, , Hungary

Site Status

1205.14.274 Boehringer Ingelheim Investigational Site

Zalaegerszeg, , Hungary

Site Status

1205.14.108 Boehringer Ingelheim Investigational Site

Cuernavaca, Mor. México, , Mexico

Site Status

1205.14.101 Boehringer Ingelheim Investigational Site

Hermosillo, Sonora, , Mexico

Site Status

1205.14.119 Boehringer Ingelheim Investigational Site

Metepec, , Mexico

Site Status

1205.14.117 Boehringer Ingelheim Investigational Site

Mexico City, , Mexico

Site Status

1205.14.120 Boehringer Ingelheim Investigational Site

Mexico City, , Mexico

Site Status

1205.14.102 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1205.14.116 Boehringer Ingelheim Investigational Site

Monterrey, Nuevo León, , Mexico

Site Status

1205.14.105 Boehringer Ingelheim Investigational Site

Zapopan, Jal., , Mexico

Site Status

1205.14.251 Boehringer Ingelheim Investigational Site

Chrzanów, , Poland

Site Status

1205.14.253 Boehringer Ingelheim Investigational Site

Gdansk, , Poland

Site Status

1205.14.254 Boehringer Ingelheim Investigational Site

Gdansk, , Poland

Site Status

1205.14.246 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1205.14.241 Boehringer Ingelheim Investigational Site

Lodz, , Poland

Site Status

1205.14.242 Boehringer Ingelheim Investigational Site

Lodz, , Poland

Site Status

1205.14.255 Boehringer Ingelheim Investigational Site

Miechów, , Poland

Site Status

1205.14.248 Boehringer Ingelheim Investigational Site

Ruda Śląska, , Poland

Site Status

1205.14.249 Boehringer Ingelheim Investigational Site

Tarnowskie Góry, , Poland

Site Status

1205.14.252 Boehringer Ingelheim Investigational Site

Wilkowice, , Poland

Site Status

1205.14.243 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

Site Status

1205.14.244 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

Site Status

1205.14.245 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

Site Status

1205.14.247 Boehringer Ingelheim Investigational Site

Zabrze, , Poland

Site Status

1205.14.301 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1205.14.302 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1205.14.303 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1205.14.304 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1205.14.305 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1205.14.306 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1205.14.310 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1205.14.311 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1205.14.312 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1205.14.313 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1205.14.314 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1205.14.307 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1205.14.308 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1205.14.309 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1205.14.225 Boehringer Ingelheim Investigational Site

Gyeonggi-do, , South Korea

Site Status

1205.14.228 Boehringer Ingelheim Investigational Site

Gyeonggi-do, , South Korea

Site Status

1205.14.227 Boehringer Ingelheim Investigational Site

Seongdong-gu, , South Korea

Site Status

1205.14.221 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1205.14.222 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1205.14.223 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1205.14.224 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1205.14.226 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1205.14.182 Boehringer Ingelheim Investigational Site

Badajoz, , Spain

Site Status

1205.14.186 Boehringer Ingelheim Investigational Site

Cáceres, , Spain

Site Status

1205.14.183 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1205.14.191 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1205.14.181 Boehringer Ingelheim Investigational Site

Terrassa (Barcelona), , Spain

Site Status

1205.14.190 Boehringer Ingelheim Investigational Site

Torrevieja, , Spain

Site Status

1205.14.189 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1205.14.187 Boehringer Ingelheim Investigational Site

Vigo, , Spain

Site Status

1205.14.207 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1205.14.208 Boehringer Ingelheim Investigational Site

Chiayi City, , Taiwan

Site Status

1205.14.210 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1205.14.209 Boehringer Ingelheim Investigational Site

Kaohsiung County, , Taiwan

Site Status

1205.14.205 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1205.14.206 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1205.14.202 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1205.14.204 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1205.14.201 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Germany Hungary Mexico Poland Russia South Korea Spain Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respir Med. 2013 Jun;107(6):854-62. doi: 10.1016/j.rmed.2013.02.005. Epub 2013 Mar 13.

Reference Type DERIVED
PMID: 23490224 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-007946-42

Identifier Type: -

Identifier Source: secondary_id

1205.14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.