Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

MATHS: Assessment of Health-status of Patients With COPD on MAintenance THerapy With Spiriva® HH Measured by CAT Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644734
• Other study ID #: 205.502
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2012
• Last updated: April 30, 2014
• Start date: November 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1328
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Male and female ambulatory outpatients being seen in a participating physicians office for routine care,

• Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),

• Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,

• Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.

Exclusion criteria:

• Uncooperative patients as judged by the physician,

• Patients with any conditions excluded as per Country specific package insert,

• Patients currently enrolled in any clinical trial,

• Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.

Study Design

Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Spiriva HandiHaler

Locations

Country	Name	City	State
Poland	Boehringer Ingelheim Investigational Site 236	Andrychow
Poland	Boehringer Ingelheim Investigational Site 170	Bialystok
Poland	Boehringer Ingelheim Investigational Site 184	Bialystok
Poland	Boehringer Ingelheim Investigational Site 240	Bialystok
Poland	Boehringer Ingelheim Investigational Site 44	Bialystok
Poland	Boehringer Ingelheim Investigational Site 84	Bialystok
Poland	Boehringer Ingelheim Investigational Site 33	Bielsko-Biala
Poland	Boehringer Ingelheim Investigational Site 34	Bielsko-Biala
Poland	Boehringer Ingelheim Investigational Site 35	Bielsko-Biala
Poland	Boehringer Ingelheim Investigational Site 79	Biskupiec
Poland	Boehringer Ingelheim Investigational Site 116	Bochnia
Poland	Boehringer Ingelheim Investigational Site 115	Brzesko
Poland	Boehringer Ingelheim Investigational Site 138	Brzesko
Poland	Boehringer Ingelheim Investigational Site 185	Brzeziny
Poland	Boehringer Ingelheim Investigational Site 90	Brzozow
Poland	Boehringer Ingelheim Investigational Site 105	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 119	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 123	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 222	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 27	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 21	Chelm
Poland	Boehringer Ingelheim Investigational Site 22	Chelm
Poland	Boehringer Ingelheim Investigational Site 11	Chelmsko Slaskie
Poland	Boehringer Ingelheim Investigational Site 233	Chodziez
Poland	Boehringer Ingelheim Investigational Site 226	Chojnice
Poland	Boehringer Ingelheim Investigational Site 149	Chorzow
Poland	Boehringer Ingelheim Investigational Site 153	Chorzow
Poland	Boehringer Ingelheim Investigational Site 88	Ciechanow
Poland	Boehringer Ingelheim Investigational Site 232	Czarnkow
Poland	Boehringer Ingelheim Investigational Site 229	Czestochowa
Poland	Boehringer Ingelheim Investigational Site 4	Czestochowa
Poland	Boehringer Ingelheim Investigational Site 23	Dabrowa Gornicza
Poland	Boehringer Ingelheim Investigational Site 92	Domaradz
Poland	Boehringer Ingelheim Investigational Site 246	Dziergowice
Poland	Boehringer Ingelheim Investigational Site 133	Gdansk
Poland	Boehringer Ingelheim Investigational Site 134	Gdansk
Poland	Boehringer Ingelheim Investigational Site 136	Gdansk
Poland	Boehringer Ingelheim Investigational Site 155	Gdansk
Poland	Boehringer Ingelheim Investigational Site 156	Gdansk
Poland	Boehringer Ingelheim Investigational Site 20	Gdansk
Poland	Boehringer Ingelheim Investigational Site 234	Gdansk
Poland	Boehringer Ingelheim Investigational Site 31	Gdansk
Poland	Boehringer Ingelheim Investigational Site 41	Gdynia
Poland	Boehringer Ingelheim Investigational Site 217	Gliwice
Poland	Boehringer Ingelheim Investigational Site 247	Glucholazy
Poland	Boehringer Ingelheim Investigational Site 85	Gora
Poland	Boehringer Ingelheim Investigational Site 50	Gorzow Wielkopolski
Poland	Boehringer Ingelheim Investigational Site 174	Grodzisk Mazowiecki
Poland	Boehringer Ingelheim Investigational Site 176	Grodzisk Mazowiecki
Poland	Boehringer Ingelheim Investigational Site 56	Gryfice
Poland	Boehringer Ingelheim Investigational Site 179	Jaroslaw
Poland	Boehringer Ingelheim Investigational Site 108	Jaslo
Poland	Boehringer Ingelheim Investigational Site 225	Jaslo
Poland	Boehringer Ingelheim Investigational Site 8	Jaslo
Poland	Boehringer Ingelheim Investigational Site 243	Jedrzejow
Poland	Boehringer Ingelheim Investigational Site 148	Jelenia Gora
Poland	Boehringer Ingelheim Investigational Site 162	Katowice
Poland	Boehringer Ingelheim Investigational Site 163	Katowice
Poland	Boehringer Ingelheim Investigational Site 164	Katowice
Poland	Boehringer Ingelheim Investigational Site 212	Katowice
Poland	Boehringer Ingelheim Investigational Site 69	Kcynia
Poland	Boehringer Ingelheim Investigational Site 112	Kielce
Poland	Boehringer Ingelheim Investigational Site 18	Kielce
Poland	Boehringer Ingelheim Investigational Site 19	Kielce
Poland	Boehringer Ingelheim Investigational Site 13	Klodzko
Poland	Boehringer Ingelheim Investigational Site 49	Kolobrzeg
Poland	Boehringer Ingelheim Investigational Site 219	Konin
Poland	Boehringer Ingelheim Investigational Site 141	Konskie
Poland	Boehringer Ingelheim Investigational Site 142	Konskie
Poland	Boehringer Ingelheim Investigational Site 51	Koszalin
Poland	Boehringer Ingelheim Investigational Site 52	Koszalin
Poland	Boehringer Ingelheim Investigational Site 122	Krakow
Poland	Boehringer Ingelheim Investigational Site 135	Krakow
Poland	Boehringer Ingelheim Investigational Site 143	Krakow
Poland	Boehringer Ingelheim Investigational Site 146	Krakow
Poland	Boehringer Ingelheim Investigational Site 171	Krakow
Poland	Boehringer Ingelheim Investigational Site 177	Krakow
Poland	Boehringer Ingelheim Investigational Site 214	Krakow
Poland	Boehringer Ingelheim Investigational Site 87	Krakow
Poland	Boehringer Ingelheim Investigational Site 94	Krakow
Poland	Boehringer Ingelheim Investigational Site 129	Krasnik
Poland	Boehringer Ingelheim Investigational Site 204	Krasnik
Poland	Boehringer Ingelheim Investigational Site 207	Krasnik
Poland	Boehringer Ingelheim Investigational Site 192	Krosno
Poland	Boehringer Ingelheim Investigational Site 194	Kutno
Poland	Boehringer Ingelheim Investigational Site 86	Ledziny
Poland	Boehringer Ingelheim Investigational Site 97	Legionowo
Poland	Boehringer Ingelheim Investigational Site 127	Lisnik Duzy
Poland	Boehringer Ingelheim Investigational Site 187	Lodz
Poland	Boehringer Ingelheim Investigational Site 188	Lodz
Poland	Boehringer Ingelheim Investigational Site 193	Lodz
Poland	Boehringer Ingelheim Investigational Site 198	Lodz
Poland	Boehringer Ingelheim Investigational Site 206	Lodz
Poland	Boehringer Ingelheim Investigational Site 57	Lomza
Poland	Boehringer Ingelheim Investigational Site 58	Lomza
Poland	Boehringer Ingelheim Investigational Site 186	Lowicz
Poland	Boehringer Ingelheim Investigational Site 158	Luban
Poland	Boehringer Ingelheim Investigational Site 37	Lubartow
Poland	Boehringer Ingelheim Investigational Site 172	Lubin
Poland	Boehringer Ingelheim Investigational Site 173	Lubin
Poland	Boehringer Ingelheim Investigational Site 196	Lubin
Poland	Boehringer Ingelheim Investigational Site 124	Lublin
Poland	Boehringer Ingelheim Investigational Site 17	Lublin
Poland	Boehringer Ingelheim Investigational Site 29	Lublin
Poland	Boehringer Ingelheim Investigational Site 7	Lublin
Poland	Boehringer Ingelheim Investigational Site 242	Lubliniec
Poland	Boehringer Ingelheim Investigational Site 209	Lubon
Poland	Boehringer Ingelheim Investigational Site 106	Ludwikowo
Poland	Boehringer Ingelheim Investigational Site 30	Lukow
Poland	Boehringer Ingelheim Investigational Site 45	Makow Mazowiecki
Poland	Boehringer Ingelheim Investigational Site 168	Malbork
Poland	Boehringer Ingelheim Investigational Site 110	Mielec
Poland	Boehringer Ingelheim Investigational Site 159	Milicz
Poland	Boehringer Ingelheim Investigational Site 150	Myslowice
Poland	Boehringer Ingelheim Investigational Site 25	Myszkow
Poland	Boehringer Ingelheim Investigational Site 215	Nisko
Poland	Boehringer Ingelheim Investigational Site 128	Nowy Dwor Gdanski
Poland	Boehringer Ingelheim Investigational Site 109	Nowy Sacz
Poland	Boehringer Ingelheim Investigational Site 154	Olawa
Poland	Boehringer Ingelheim Investigational Site 72	Olecko
Poland	Boehringer Ingelheim Investigational Site 36	Olsztyn
Poland	Boehringer Ingelheim Investigational Site 245	Opatow
Poland	Boehringer Ingelheim Investigational Site 114	Ostrowiec Swietokrzyski
Poland	Boehringer Ingelheim Investigational Site 145	Ostrowiec Swietokrzyski
Poland	Boehringer Ingelheim Investigational Site 237	Pabianice
Poland	Boehringer Ingelheim Investigational Site 182	Papowo Biskupie
Poland	Boehringer Ingelheim Investigational Site 216	Pawonkow
Poland	Boehringer Ingelheim Investigational Site 189	Piekary Slaskie
Poland	Boehringer Ingelheim Investigational Site 32	Pietrzykowice
Poland	Boehringer Ingelheim Investigational Site 40	Pila
Poland	Boehringer Ingelheim Investigational Site 203	Piotrkow Trybunalski
Poland	Boehringer Ingelheim Investigational Site 59	Plock
Poland	Boehringer Ingelheim Investigational Site 93	Pniewy
Poland	Boehringer Ingelheim Investigational Site 130	Poniatowa
Poland	Boehringer Ingelheim Investigational Site 201	Poznan
Poland	Boehringer Ingelheim Investigational Site 208	Poznan
Poland	Boehringer Ingelheim Investigational Site 227	Poznan
Poland	Boehringer Ingelheim Investigational Site 228	Poznan
Poland	Boehringer Ingelheim Investigational Site 231	Poznan
Poland	Boehringer Ingelheim Investigational Site 126	Prabuty
Poland	Boehringer Ingelheim Investigational Site 218	Proszowice
Poland	Boehringer Ingelheim Investigational Site 131	Pruszcz Gdanski
Poland	Boehringer Ingelheim Investigational Site 191	Przemysl
Poland	Boehringer Ingelheim Investigational Site 169	Rabka Zdroj
Poland	Boehringer Ingelheim Investigational Site 117	Radom
Poland	Boehringer Ingelheim Investigational Site 118	Radom
Poland	Boehringer Ingelheim Investigational Site 151	Ruda Slaska
Poland	Boehringer Ingelheim Investigational Site 152	Ruda Slaska
Poland	Boehringer Ingelheim Investigational Site 230	Ruda Slaska
Poland	Boehringer Ingelheim Investigational Site 82	Ruda Slaska
Poland	Boehringer Ingelheim Investigational Site 180	Rumia
Poland	Boehringer Ingelheim Investigational Site 239	Rumia
Poland	Boehringer Ingelheim Investigational Site 5	Rumia
Poland	Boehringer Ingelheim Investigational Site 104	Rybnik
Poland	Boehringer Ingelheim Investigational Site 183	Rybnik
Poland	Boehringer Ingelheim Investigational Site 83	Rybnik
Poland	Boehringer Ingelheim Investigational Site 175	Rzeszow
Poland	Boehringer Ingelheim Investigational Site 178	Rzeszow
Poland	Boehringer Ingelheim Investigational Site 190	Sanok
Poland	Boehringer Ingelheim Investigational Site 73	Sawin
Poland	Boehringer Ingelheim Investigational Site 78	Sejny
Poland	Boehringer Ingelheim Investigational Site 160	Siewierz
Poland	Boehringer Ingelheim Investigational Site 241	Skarzysko Kamienna
Poland	Boehringer Ingelheim Investigational Site 157	Skawina
Poland	Boehringer Ingelheim Investigational Site 10	Skoczow
Poland	Boehringer Ingelheim Investigational Site 167	Skrzyszow
Poland	Boehringer Ingelheim Investigational Site 53	Slawno
Poland	Boehringer Ingelheim Investigational Site 96	Slubice
Poland	Boehringer Ingelheim Investigational Site 205	Slupca
Poland	Boehringer Ingelheim Investigational Site 14	Sokolowsko
Poland	Boehringer Ingelheim Investigational Site 113	Sopot
Poland	Boehringer Ingelheim Investigational Site 166	Sosnowiec
Poland	Boehringer Ingelheim Investigational Site 24	Sosnowiec
Poland	Boehringer Ingelheim Investigational Site 107	Srem
Poland	Boehringer Ingelheim Investigational Site 213	Srem
Poland	Boehringer Ingelheim Investigational Site 125	Stalowa Wola
Poland	Boehringer Ingelheim Investigational Site 144	Starachowice
Poland	Boehringer Ingelheim Investigational Site 80	Starachowice
Poland	Boehringer Ingelheim Investigational Site 120	Stargard Szczecinski
Poland	Boehringer Ingelheim Investigational Site 95	Sucha Beskidzka
Poland	Boehringer Ingelheim Investigational Site 16	Suprasl
Poland	Boehringer Ingelheim Investigational Site 54	Suwalki
Poland	Boehringer Ingelheim Investigational Site 55	Suwalki
Poland	Boehringer Ingelheim Investigational Site 1	Swidnik
Poland	Boehringer Ingelheim Investigational Site 181	Swiecie
Poland	Boehringer Ingelheim Investigational Site 76	Sycow
Poland	Boehringer Ingelheim Investigational Site 43	Szczecin
Poland	Boehringer Ingelheim Investigational Site 48	Szczecin
Poland	Boehringer Ingelheim Investigational Site 61	Szczecin
Poland	Boehringer Ingelheim Investigational Site 66	Szczecin
Poland	Boehringer Ingelheim Investigational Site 67	Szczecin
Poland	Boehringer Ingelheim Investigational Site 26	Szczecinek
Poland	Boehringer Ingelheim Investigational Site 111	Tarnobrzeg
Poland	Boehringer Ingelheim Investigational Site 224	Tarnobrzeg
Poland	Boehringer Ingelheim Investigational Site 139	Tarnow
Poland	Boehringer Ingelheim Investigational Site 140	Tarnow
Poland	Boehringer Ingelheim Investigational Site 200	Tarnowskie Gory
Poland	Boehringer Ingelheim Investigational Site 101	Torun
Poland	Boehringer Ingelheim Investigational Site 70	Torun
Poland	Boehringer Ingelheim Investigational Site 71	Torun
Poland	Boehringer Ingelheim Investigational Site 220	Trzcianka Lubuska
Poland	Boehringer Ingelheim Investigational Site 103	Twardogora
Poland	Boehringer Ingelheim Investigational Site 147	Tychy
Poland	Boehringer Ingelheim Investigational Site 244	Tychy
Poland	Boehringer Ingelheim Investigational Site 38	Uchanie
Poland	Boehringer Ingelheim Investigational Site 39	Walcz
Poland	Boehringer Ingelheim Investigational Site 100	Warszawa
Poland	Boehringer Ingelheim Investigational Site 121	Warszawa
Poland	Boehringer Ingelheim Investigational Site 137	Warszawa
Poland	Boehringer Ingelheim Investigational Site 161	Warszawa
Poland	Boehringer Ingelheim Investigational Site 165	Warszawa
Poland	Boehringer Ingelheim Investigational Site 2	Warszawa
Poland	Boehringer Ingelheim Investigational Site 210	Warszawa
Poland	Boehringer Ingelheim Investigational Site 223	Warszawa
Poland	Boehringer Ingelheim Investigational Site 238	Warszawa
Poland	Boehringer Ingelheim Investigational Site 3	Warszawa
Poland	Boehringer Ingelheim Investigational Site 42	Warszawa
Poland	Boehringer Ingelheim Investigational Site 46	Warszawa
Poland	Boehringer Ingelheim Investigational Site 74	Warszawa
Poland	Boehringer Ingelheim Investigational Site 91	Warszawa
Poland	Boehringer Ingelheim Investigational Site 99	Warszawa
Poland	Boehringer Ingelheim Investigational Site 6	Wejherowo
Poland	Boehringer Ingelheim Investigational Site 199	Wieliczna
Poland	Boehringer Ingelheim Investigational Site 235	Wielun
Poland	Boehringer Ingelheim Investigational Site 197	Witonia
Poland	Boehringer Ingelheim Investigational Site 65	Wloc³awek
Poland	Boehringer Ingelheim Investigational Site 28	Wodzislaw Slaski
Poland	Boehringer Ingelheim Investigational Site 98	Wolomin
Poland	Boehringer Ingelheim Investigational Site 102	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 202	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 221	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 62	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 63	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 64	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 89	Wroclaw
Poland	Boehringer Ingelheim Investigational Site 12	Zabkowice Slaskie
Poland	Boehringer Ingelheim Investigational Site 9	Zabkowice Slaskie
Poland	Boehringer Ingelheim Investigational Site 68	Zabrze
Poland	Boehringer Ingelheim Investigational Site 75	Zabrze
Poland	Boehringer Ingelheim Investigational Site 77	Zabrze
Poland	Boehringer Ingelheim Investigational Site 60	Zagoty
Poland	Boehringer Ingelheim Investigational Site 132	Zblewo
Poland	Boehringer Ingelheim Investigational Site 195	Zgierz
Poland	Boehringer Ingelheim Investigational Site 15	Zielona Gora
Poland	Boehringer Ingelheim Investigational Site 47	Zielona Gora
Poland	Boehringer Ingelheim Investigational Site 81	Zielonka k/Warszawy
Poland	Boehringer Ingelheim Investigational Site 211	Zyrardow

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Maintaining or Improving Their Health Status	The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is =0.	Baseline, 3 months	No
Secondary	Change in the Total CAT Score (Value Baseline Minus 3 Months)	The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.	Baseline, 3 months	No