Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00297115

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 287 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Roflumilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,568 participants
Where: 287 sitesin 8 countries
Study dates: Mar 2006to Aug 2008
Phase: Phase 3
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

COPD patients having at least one exacerbation within last year
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

COPD exacerbation not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease

Trial locations and contacts

287 sites in 8 countries.

Country

City, postcode or hospital

287 sites in 8 countries

United States151 sites

Altana Pharma/Nycomed Investigational Site
Absecon, New Jersey, 08201
Altana Pharma/Nycomed Investigational Site
Anaheim, California, 92801
Altana Pharma/Nycomed Investigational Site
Atlanta, Georgia, 30342
Altana Pharma/Nycomed Investigational Site
Bayou La Batre, Alabama, 36509
Altana Pharma/Nycomed Investigational Site
Birmingham, Alabama, 35249
Altana Pharma/Nycomed Investigational Site
Birmingham, Alabama, 35294
Altana Pharma/Nycomed Investigational Site
Blue Ridge, Georgia, 30513
Altana Pharma/Nycomed Investigational Site
Boerne, Texas, 78006
Altana Pharma/Nycomed Investigational Site
Boston, Massachusetts, 02114
Altana Pharma/Nycomed Investigational Site
Bozeman, Montana, 59718
Altana Pharma/Nycomed Investigational Site
Brighton, Michigan, 48114
Altana Pharma/Nycomed Investigational Site
Bullhead City, Arizona, 85442
Altana Pharma/Nycomed Investigational Site
Burbank, California, 91505
Altana Pharma/Nycomed Investigational Site
Butte, Montana, 59701
Altana Pharma/Nycomed Investigational Site
Camillus, New York, 13031
Altana Pharma/Nycomed Investigational Site
Campbellsville, Kentucky, 42718
Altana Pharma/Nycomed Investigational Site
Canton, Ohio, 44718
Altana Pharma/Nycomed Investigational Site
Carlsbad, California, 92008
Altana Pharma/Nycomed Investigational Site
Champaign, Illinois, 61820
Altana Pharma/Nycomed Investigational Site
Charleston, South Carolina, 29406
Altana Pharma/Nycomed Investigational Site
Charleston, West Virginia, 25304
Altana Pharma/Nycomed Investigational Site
Charlotte, North Carolina, 28207
Altana Pharma/Nycomed Investigational Site
Chesterfield, Missouri, 63017
Altana Pharma/Nycomed Investigational Site
Chicago, Illinois, 60611
Altana Pharma/Nycomed Investigational Site
Cincinnati, Ohio, 45231
Altana Pharma/Nycomed Investigational Site
Clearwater, Florida, 33756
Altana Pharma/Nycomed Investigational Site
Columbia, Maryland, 21044
Altana Pharma/Nycomed Investigational Site
Columbus, Georgia, 31901
Altana Pharma/Nycomed Investigational Site
Columbus, Ohio, 43215
Altana Pharma/Nycomed Investigational Site
Corning, New York, 14830
Altana Pharma/Nycomed Investigational Site
Corsicana, Texas, 75110
Altana Pharma/Nycomed Investigational Site
Cortland, New York, 13045
Altana Pharma/Nycomed Investigational Site
Decatur, Georgia, 30033
Altana Pharma/Nycomed Investigational Site
DeLand, Florida, 32720
Altana Pharma/Nycomed Investigational Site
Denver, Colorado, 80206
Altana Pharma/Nycomed Investigational Site
Dubuque, Iowa, 52001
Altana Pharma/Nycomed Investigational Site
Duluth, Minnesota, 55805
Altana Pharma/Nycomed Investigational Site
Edina, Minnesota, 55435
Altana Pharma/Nycomed Investigational Site
Elk Grove Village, Illinois, 60007
Altana Pharma/Nycomed Investigational Site
Elkhart, Indiana, 46514
Altana Pharma/Nycomed Investigational Site
Erie, Pennsylvania, 16506
Altana Pharma/Nycomed Investigational Site
Fort Dodge, Iowa, 50501
Altana Pharma/Nycomed Investigational Site
Fort Eisenhower, Georgia, 30905
Altana Pharma/Nycomed Investigational Site
Fort Lauderdale, Florida, 33316
Altana Pharma/Nycomed Investigational Site
Fort Smith, Arkansas, 72917
Altana Pharma/Nycomed Investigational Site
Fort Worth, Texas, 76109
Altana Pharma/Nycomed Investigational Site
Fresno, California, 93720
Altana Pharma/Nycomed Investigational Site
Glendale, Wisconsin, 53212
Altana Pharma/Nycomed Investigational Site
Glendale, Wisconsin, 53217
Altana Pharma/Nycomed Investigational Site
Greenville, South Carolina, 29605
Altana Pharma/Nycomed Investigational Site
Greenville, South Carolina, 29615
Altana Pharma/Nycomed Investigational Site
Greer, South Carolina, 29651
Altana Pharma/Nycomed Investigational Site
Hamilton, New Jersey, 08610
Altana Pharma/Nycomed Investigational Site
Hazard, Kentucky, 41701
Altana Pharma/Nycomed Investigational Site
Hershey, Pennsylvania, 17033
Altana Pharma/Nycomed Investigational Site
Houston, Texas, 77005
Altana Pharma/Nycomed Investigational Site
Houston, Texas, 77024
Altana Pharma/Nycomed Investigational Site
Huntersville, North Carolina, 28070
Altana Pharma/Nycomed Investigational Site
Huntsville, Alabama, 35801
Altana Pharma/Nycomed Investigational Site
Hurst, Texas, 76054
Altana Pharma/Nycomed Investigational Site
Indianapolis, Indiana, 46202
Altana Pharma/Nycomed Investigational Site
Indianapolis, Indiana, 46254
Altana Pharma/Nycomed Investigational Site
Interlochen, Michigan, 49643
Altana Pharma/Nycomed Investigational Site
Iowa City, Iowa, 52242
Altana Pharma/Nycomed Investigational Site
Jacksonville, Florida, 32204
Altana Pharma/Nycomed Investigational Site
Jefferson City, Missouri, 65101
Altana Pharma/Nycomed Investigational Site
Johnson City, Tennessee, 37604
Altana Pharma/Nycomed Investigational Site
Johnston, Rhode Island, 2919
Altana Pharma/Nycomed Investigational Site
Kansas City, Missouri, 64106
Altana Pharma/Nycomed Investigational Site
Kansas City, Missouri, 64111
Altana Pharma/Nycomed Investigational Site
Knoxville, Tennessee, 37920
Altana Pharma/Nycomed Investigational Site
Lakewood, California, 90712
Altana Pharma/Nycomed Investigational Site
Las Vegas, Nevada, 89123
Altana Pharma/Nycomed Investigational Site
Las Vegas, Nevada, 89176
Altana Pharma/Nycomed Investigational Site
Little Rock, Arkansas, 72205
Altana Pharma/Nycomed Investigational Site
Livonia, Michigan, 48152
Altana Pharma/Nycomed Investigational Site
Long Beach, California, 90822
Altana Pharma/Nycomed Investigational Site
Los Alamitos, California, 90720
Altana Pharma/Nycomed Investigational Site
Los Angeles, California, 90033
Altana Pharma/Nycomed Investigational Site
Louisville, Kentucky, 40207
Altana Pharma/Nycomed Investigational Site
Lynchburg, Virginia, 24501
Altana Pharma/Nycomed Investigational Site
Marietta, Georgia, 30060
Altana Pharma/Nycomed Investigational Site
McKinney, Texas, 75069
Altana Pharma/Nycomed Investigational Site
Medford, Oregon, 97504
Altana Pharma/Nycomed Investigational Site
Memphis, Tennessee, 38163
Altana Pharma/Nycomed Investigational Site
Metairie, Louisiana, 70006
Altana Pharma/Nycomed Investigational Site
Miami, Florida, 33173
Altana Pharma/Nycomed Investigational Site
Miami, Florida, 33176
Altana Pharma/Nycomed Investigational Site
Miami Beach, Florida, 33140
Altana Pharma/Nycomed Investigational Site
Minneapolis, Minnesota, 55407
Altana Pharma/Nycomed Investigational Site
Nashville, Tennessee, 37203
Altana Pharma/Nycomed Investigational Site
New Albany, Indiana, 47150
Altana Pharma/Nycomed Investigational Site
New Hyde Park, New York, 11040
Altana Pharma/Nycomed Investigational Site
New Hyde Park, New York, 11042
Altana Pharma/Nycomed Investigational Site
New Tazewell, Tennessee, 37825
Altana Pharma/Nycomed Investigational Site
North Chicago, Illinois, 60064
Altana Pharma/Nycomed Investigational Site
Ocala, Florida, 34471
Altana Pharma/Nycomed Investigational Site
Oklahoma City, Oklahoma, 73120
Altana Pharma/Nycomed Investigational Site
Olathe, Kansas, 66061
Altana Pharma/Nycomed Investigational Site
Omaha, Nebraska, 68131
Altana Pharma/Nycomed Investigational Site
Ormand Beach, Florida, 32174
Altana Pharma/Nycomed Investigational Site
Peoria, Illinois, 61603
Altana Pharma/Nycomed Investigational Site
Philadelphia, Pennsylvania, 19107
Altana Pharma/Nycomed Investigational Site
Philadelphia, Pennsylvania, 19140
Altana Pharma/Nycomed Investigational Site
Phoenix, Arizona, 85012
Altana Pharma/Nycomed Investigational Site
Phoenix, Arizona, 85023
Altana Pharma/Nycomed Investigational Site
Pittsburgh, Pennsylvania, 15221
Altana Pharma/Nycomed Investigational Site
Port Orange, Florida, 33127
Altana Pharma/Nycomed Investigational Site
Portage, Michigan, 49002
Altana Pharma/Nycomed Investigational Site
Portland, Oregon, 97220
Altana Pharma/Nycomed Investigational Site
Rincon, Georgia, 594
Altana Pharma/Nycomed Investigational Site
River Forest, Illinois, 60305
Altana Pharma/Nycomed Investigational Site
Rochester, Minnesota, 55905
Altana Pharma/Nycomed Investigational Site
Roseville, California, 95678
Altana Pharma/Nycomed Investigational Site
Sacramento, California, 95831
Altana Pharma/Nycomed Investigational Site
Saginaw, Michigan, 48602
Altana Pharma/Nycomed Investigational Site
Salt Lake City, Utah, 84107
Altana Pharma/Nycomed Investigational Site
Salt Lake City, Utah, 84124
Altana Pharma/Nycomed Investigational Site
San Antonio, Texas, 78205
Altana Pharma/Nycomed Investigational Site
San Antonio, Texas, 78229
Altana Pharma/Nycomed Investigational Site
San Diego, California, 92103
Altana Pharma/Nycomed Investigational Site
San Diego, California, 92120
Altana Pharma/Nycomed Investigational Site
Savannah, Georgia, 31406
Altana Pharma/Nycomed Investigational Site
Seattle, Washington, 98104
Altana Pharma/Nycomed Investigational Site
Seguin, Texas, 78155
Altana Pharma/Nycomed Investigational Site
Sepulveda, California, 91343
Altana Pharma/Nycomed Investigational Site
South Bound Brook, New Jersey, 08880
Altana Pharma/Nycomed Investigational Site
Spokane, Washington, 99216
Altana Pharma/Nycomed Investigational Site
St Louis, Missouri, 63122
Altana Pharma/Nycomed Investigational Site
St Louis, Missouri, 63141
Altana Pharma/Nycomed Investigational Site
Stockton, California, 95207
Altana Pharma/Nycomed Investigational Site
Stoneboro, Pennsylvania, 16153
Altana Pharma/Nycomed Investigational Site
Sunset, Missouri, 70584
Altana Pharma/Nycomed Investigational Site
Swarthmore, Pennsylvania, 19081
Altana Pharma/Nycomed Investigational Site
Sylvania, Ohio, 43560
Altana Pharma/Nycomed Investigational Site
Syracuse, New York, 13210
Altana Pharma/Nycomed Investigational Site
Tamarac, Florida, 33321
Altana Pharma/Nycomed Investigational Site
Toledo, Ohio, 43608
Altana Pharma/Nycomed Investigational Site
Toledo, Ohio, 43614
Altana Pharma/Nycomed Investigational Site
Toledo, Ohio, 43617
Altana Pharma/Nycomed Investigational Site
Topeka, Kansas, 66606
Altana Pharma/Nycomed Investigational Site
Twin Falls, Idaho, 83301
Altana Pharma/Nycomed Investigational Site
Tyler, Texas, 75708
Altana Pharma/Nycomed Investigational Site
Union, South Carolina, 29379
Altana Pharma/Nycomed Investigational Site
Vero Beach, Florida, 32960
Altana Pharma/Nycomed Investigational Site
Washington D.C., District of Columbia, 20017
Altana Pharma/Nycomed Investigational Site
Waterbury, Connecticut, 6708
Altana Pharma/Nycomed Investigational Site
Waterloo, Iowa, 50702
Altana Pharma/Nycomed Investigational Site
West Monroe, Louisiana, 71291
Altana Pharma/Nycomed Investigational Site
Williamston, South Carolina, 29697
Altana Pharma/Nycomed Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada40 sites

Altana Pharma/Nycomed Investigational Site
Antigonish Nova Scotia, B2G2C2
Altana Pharma/Nycomed Investigational Site
Bridgewater, B4V3N2
Altana Pharma/Nycomed Investigational Site
Burnaby, British Columbia, V5G 1T4
Altana Pharma/Nycomed Investigational Site
Calgary, Alberta, T2N 4N1
Altana Pharma/Nycomed Investigational Site
Calgary, Alberta, T3C 3P1
Altana Pharma/Nycomed Investigational Site
Calgary, T1Y6J4
Altana Pharma/Nycomed Investigational Site
Chatham, Ontario, N7M 1R2
Altana Pharma/Nycomed Investigational Site
Corunna, N0N1G0
Altana Pharma/Nycomed Investigational Site
Edmonton, Alberta, T5C 0A3
Altana Pharma/Nycomed Investigational Site
Edmonton, T5N4L8
Altana Pharma/Nycomed Investigational Site
Fort Erie, L2A1Z3
Altana Pharma/Nycomed Investigational Site
Grimsby, L3M1P3
Altana Pharma/Nycomed Investigational Site
Hamilton, Ontario, L8M 1K7
Altana Pharma/Nycomed Investigational Site
Hamilton, L8N3Z5
Altana Pharma/Nycomed Investigational Site
London, Ontario, N5Y 5K7
Altana Pharma/Nycomed Investigational Site
Longueuil, J4N1E1
Altana Pharma/Nycomed Investigational Site
Mississauga, Ontario, L5M 2V8
Altana Pharma/Nycomed Investigational Site
Montreal, Quebec, H1V 1X5
Altana Pharma/Nycomed Investigational Site
Montreal, Quebec, H3S 2W1
Altana Pharma/Nycomed Investigational Site
Montreal, H2L2W5
Altana Pharma/Nycomed Investigational Site
Ontario, L2R2Z9
Altana Pharma/Nycomed Investigational Site
Ottawa, Ontario, K1Y 4E9
Altana Pharma/Nycomed Investigational Site
Penticton, British Columbia, V2A 5C8
Altana Pharma/Nycomed Investigational Site
Richmond Hill, L4C2N9
Altana Pharma/Nycomed Investigational Site
Saint John, E3M3W5
Altana Pharma/Nycomed Investigational Site
Saint Romuald, Quebec, G6W 5M6
Altana Pharma/Nycomed Investigational Site
Saint-Jérôme, J7Z5T3
Altana Pharma/Nycomed Investigational Site
Saint-Léonard, H1S3A9
Altana Pharma/Nycomed Investigational Site
Sainte-Foy, Quebec, G1V4G5
Altana Pharma/Nycomed Investigational Site
Sarnia, Ontario, N7T 4X3
Altana Pharma/Nycomed Investigational Site
Scarborough Village, Ontario, M1B 4Z8
Altana Pharma/Nycomed Investigational Site
Sherbrooke, Quebec, J1H 4J6
Altana Pharma/Nycomed Investigational Site
Sherbrooke, J1H5N4
Altana Pharma/Nycomed Investigational Site
Spruce Grove, Alberta, T7X 2Z8
Altana Pharma/Nycomed Investigational Site
Ste-Foy, Quebec, G1W 4R4
Altana Pharma/Nycomed Investigational Site
Toronto, Ontario, M5S 2A5
Altana Pharma/Nycomed Investigational Site
Toronto, M5G1X5
Altana Pharma/Nycomed Investigational Site
Truro, Nova Scotia, B2N 1L2
Altana Pharma/Nycomed Investigational Site
Vancouver, British Columbia, V5Z 4E1
Altana Pharma/Nycomed Investigational Site
Winnipeg, R2K3S8

Other trials in Canada

India22 sites

Altana Pharma/Nycomed Investigational Site
Bangalore, 560 002
Altana Pharma/Nycomed Investigational Site
Bangalore, 560 034
Altana Pharma/Nycomed Investigational Site
Bangalore, Karnataka, 560 029
Altana Pharma/Nycomed Investigational Site
Chennai, 600 034
Altana Pharma/Nycomed Investigational Site
Coimbatore, 641 004
Altana Pharma/Nycomed Investigational Site
Coimbatore, 641 014
Altana Pharma/Nycomed Investigational Site
Coimbatore, Tamilnadu, 641 044
Altana Pharma/Nycomed Investigational Site
Goa, 403 002
Altana Pharma/Nycomed Investigational Site
Hyderabad, 12
Altana Pharma/Nycomed Investigational Site
Indore, South Tukuganj, 452001
Altana Pharma/Nycomed Investigational Site
Mangalore, 574 160
Altana Pharma/Nycomed Investigational Site
Mangalore, 575 001
Altana Pharma/Nycomed Investigational Site
Mumbai, 400022
Altana Pharma/Nycomed Investigational Site
Mumbai, Byculla, 400 008
Altana Pharma/Nycomed Investigational Site
Mumbai, Dadar (E), 400 014
Altana Pharma/Nycomed Investigational Site
Mysore, 570004
Altana Pharma/Nycomed Investigational Site
Nagpur, 440 012
Altana Pharma/Nycomed Investigational Site
Nagpur, 440 013
Altana Pharma/Nycomed Investigational Site
Nagpur, 440012
Altana Pharma/Nycomed Investigational Site
Pune, 411 014
Altana Pharma/Nycomed Investigational Site
Pune, 411033
Altana Pharma/Nycomed Investigational Site
Shastri Nagar, Jaipur, 302 016

Other trials in India

Germany20 sites

Altana Pharma/Nycomed Investigational Site
Berlin, 10559
Altana Pharma/Nycomed Investigational Site
Berlin, 10717
Altana Pharma/Nycomed Investigational Site
Berlin, 10965
Altana Pharma/Nycomed Investigational Site
Berlin, 10969
Altana Pharma/Nycomed Investigational Site
Berlin, 12165
Altana Pharma/Nycomed Investigational Site
Berlin, 12203
Altana Pharma/Nycomed Investigational Site
Berlin, 13507
Altana Pharma/Nycomed Investigational Site
Berlin, 13597
Altana Pharma/Nycomed Investigational Site
Donaustauf, 93093
Altana Pharma/Nycomed Investigational Site
Großhansdorf, 22927
Altana Pharma/Nycomed Investigational Site
Halle, 6108
Altana Pharma/Nycomed Investigational Site
Hamburg, 20535
Altana Pharma/Nycomed Investigational Site
Landsberg/Lech, 86899
Altana Pharma/Nycomed Investigational Site
Neuruppin, 16816
Altana Pharma/Nycomed Investigational Site
Oschersleben, 39387
Altana Pharma/Nycomed Investigational Site
Potsdam, 14464
Altana Pharma/Nycomed Investigational Site
Potsdam, 14467
Altana Pharma/Nycomed Investigational Site
Regensburg, 93059
Altana Pharma/Nycomed Investigational Site
Rüdersdorf, 15562
Altana Pharma/Nycomed Investigational Site
Ulm, 89073

Other trials in Germany

Spain18 sites

Altana Pharma/Nycomed Investigational Site
Badajoz, 6080
Altana Pharma/Nycomed Investigational Site
Calde (Lugo), 27210
Altana Pharma/Nycomed Investigational Site
Cartagena, 30203
Altana Pharma/Nycomed Investigational Site
Elda, 3600
Altana Pharma/Nycomed Investigational Site
Getafe, 28905
Altana Pharma/Nycomed Investigational Site
Guadalajara, 19002
Altana Pharma/Nycomed Investigational Site
Madrid, 28006
Altana Pharma/Nycomed Investigational Site
Madrid, 28041
Altana Pharma/Nycomed Investigational Site
Merida (Badajoz), 6800
Altana Pharma/Nycomed Investigational Site
Partida de Bacarot (Alicante), 3114
Altana Pharma/Nycomed Investigational Site
Pontevedra, 36071
Altana Pharma/Nycomed Investigational Site
Requena, 46340
Altana Pharma/Nycomed Investigational Site
Santiago de Compostela, 15706
Altana Pharma/Nycomed Investigational Site
Talavera de La Reina (Toledo), 45600
Altana Pharma/Nycomed Investigational Site
Tarrasa (Barcelona), 8221
Altana Pharma/Nycomed Investigational Site
Toldeo, 45004
Altana Pharma/Nycomed Investigational Site
Valencia, 46015
Altana Pharma/Nycomed Investigational Site
Valencia, 46017

Other trials in Spain

South Africa13 sites

Altana Pharma/Nycomed Investigational Site
Bellville, Cape Town, 7530
Altana Pharma/Nycomed Investigational Site
Berea, Durban, 4000
Altana Pharma/Nycomed Investigational Site
Bloemfontein, 9301
Altana Pharma/Nycomed Investigational Site
C/O Netcare & Garsfontein Roads, 44
Altana Pharma/Nycomed Investigational Site
Cape Town, 7764
Altana Pharma/Nycomed Investigational Site
Cape Town, 8001
Altana Pharma/Nycomed Investigational Site
Cape Town, Tygerberg, 7505
Altana Pharma/Nycomed Investigational Site
Durban, Amanzimtoti, 4126
Altana Pharma/Nycomed Investigational Site
Durbanville / Cape Town, 7550
Altana Pharma/Nycomed Investigational Site
Mowbray, Cape Town, 7925
Altana Pharma/Nycomed Investigational Site
Paarl, Cape Town, 7626
Altana Pharma/Nycomed Investigational Site
Pretoria, 181
Altana Pharma/Nycomed Investigational Site
Somerset West, 7130

Other trials in South Africa

Poland12 sites

Altana Pharma/Nycomed Investigational Site
Chrzanów, 32500
Altana Pharma/Nycomed Investigational Site
Częstochowa, 42200
Altana Pharma/Nycomed Investigational Site
Działdowo, 13-200
Altana Pharma/Nycomed Investigational Site
Katowice, 40-752
Altana Pharma/Nycomed Investigational Site
Krakow, 31-202
Altana Pharma/Nycomed Investigational Site
Krakow, 31202
Altana Pharma/Nycomed Investigational Site
Lublin, 20-718
Altana Pharma/Nycomed Investigational Site
Poznan, 60-569
Altana Pharma/Nycomed Investigational Site
Warsaw, 01-138
Altana Pharma/Nycomed Investigational Site
Warsaw, 1140
Altana Pharma/Nycomed Investigational Site
Wodzisław Śląski, 44300
Altana Pharma/Nycomed Investigational Site
Zgierz, 95100

Other trials in Poland

Italy11 sites

Altana Pharma/Nycomed Investigational Site
Bergamo, 24100
Altana Pharma/Nycomed Investigational Site
Bologna, 40136
Altana Pharma/Nycomed Investigational Site
Cassano Murge, 70020
Altana Pharma/Nycomed Investigational Site
Florence, 50134
Altana Pharma/Nycomed Investigational Site
Milan, 20142
Altana Pharma/Nycomed Investigational Site
Parma, 43100
Altana Pharma/Nycomed Investigational Site
Pavia, 27100
Altana Pharma/Nycomed Investigational Site
Roma, 135
Altana Pharma/Nycomed Investigational Site
Trieste, 34100
Altana Pharma/Nycomed Investigational Site
Verona, 37100
Altana Pharma/Nycomed Investigational Site
Veruno, 28010

Other trials in Italy

About this study

Official title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Roflumilast, Placebo
Keywords: Roflumilast, COPD, Chronic obstructive pulmonary disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RoflumilastDrug
500 mcg, once daily, oral administration in the morning
PlaceboDrug
once daily

Study groups in NCT00297115
Study group	Role	What they receive
Roflumilast	Active comparator	500 mcg, once daily, oral administration in the morning Receives: Drug: Roflumilast
Placebo	Placebo comparator	once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Measured: Change from baseline over 52 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].
Measured: 52 weeks treatment period

Secondary outcomes (4)

Post-bronchodilator FEV1 [L]
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Measured: Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason
Measured: 52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Measured: Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.
Measured: Change from baseline over 52 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Aug 2008

First posted28 Feb 2006 (estimated)
Study startMar 2006
Primary completionApr 2008
Study completionAug 2008

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00297115
Sponsor's protocol ID: BY217/M2-125
Status last verified: Sep 2016
First submitted: 27 Feb 2006
Last updated: 7 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.
PubMed 19716960
Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
PubMed 28419462
Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
PubMed 24120253
Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
PubMed 23117188
Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
PubMed 20102307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
ClinicalTrials.gov ID: NCT00297115
Acronym / sponsor ID: BY217/M2-125
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast, COPD, Chronic obstructive pulmonary disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,568 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Apr 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 28 Feb 2006 (estimated)
Results: Posted 19 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Roflumilast	Active comparator	Drug: Roflumilast500 mcg, once daily, oral administration in the morning
Placebo	Placebo comparator	Drug: Placeboonce daily

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Roflumilast500 mcg, once daily, oral administration in the morning	Drug	Roflumilast
Placeboonce daily	Drug	Placebo

Primary outcome

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Time frame: Change from baseline over 52 weeks of treatment
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
COPD Exacerbation Rate (Moderate or Severe)
Time frame: 52 weeks treatment period
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].

4 secondary outcomes

Post-bronchodilator FEV1 [L]
Time frame: Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason
Time frame: 52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)
Time frame: Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
Time frame: Change from baseline over 52 weeks of treatment

Results and safety

Results posted to the registry on 19 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roflumilast	772	527
Placebo	796	550

Primary outcome: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)

Time frame: Change from baseline over 52 weeks of treatment. Least squares mean (Standard Error). Unit: mL

Measure	Roflumilast n = 730	Placebo n = 766
Value	33 (7)	-25 (7)

Roflumilast vs Placebo: Mean Difference (Net): 58 (95% CI 41 to 75), p <0.0001, ANCOVA

Population analysed: ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

Primary outcome: COPD Exacerbation Rate (Moderate or Severe)

Time frame: 52 weeks treatment period. Mean (95% Confidence Interval). Unit: exacerbations per patient per year

Measure	Roflumilast n = 772	Placebo n = 796
Value	1.210 (1.074 to 1.364)	1.485 (1.333 to 1.655)

Roflumilast vs Placebo: Rate ratio: 0.815 (95% CI 0.710 to 0.935), p = 0.0035, Poisson regression

Population analysed: ITT analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roflumilast	157 of 778 (20.2%)	145 of 778 (18.6%)	Not reported
Placebo	183 of 790 (23.2%)	81 of 790 (10.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19716960Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.
Derived from this study: PubMed 28419462Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
Derived from this study: PubMed 24120253Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
Derived from this study: PubMed 23117188Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
Derived from this study: PubMed 20102307Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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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.

AstraZeneca AstraZeneca study director

AstraZeneca

287 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 287 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 287 sites in United States, Canada, India, Germany, Spain and 3 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2011). 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?

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (time frame: Change from baseline over 52 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00297115, which also lists 5 linked publications.

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 7 Nov 2016.