Pulmonary Disease, Chronic ObstructivePhase 4NCT01644734

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

A Phase 4 study testing Spiriva HandiHaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 247 sites in Poland.

Completed

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

Official record

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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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Spiriva HandiHaler
How many people: 1,328 participants
Where: 247 sitesPoland
Study dates: Nov 2011to Mar 2013
Phase: Phase 4
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

247 sites in 1 country.

City, postcode or hospital

247 sites in 1 country

Poland247 sites

Boehringer Ingelheim Investigational Site 236
Andrychów
Boehringer Ingelheim Investigational Site 170
Bialystok
Boehringer Ingelheim Investigational Site 184
Bialystok
Boehringer Ingelheim Investigational Site 240
Bialystok
Boehringer Ingelheim Investigational Site 44
Bialystok
Boehringer Ingelheim Investigational Site 84
Bialystok
Boehringer Ingelheim Investigational Site 33
Bielsko-Biala
Boehringer Ingelheim Investigational Site 34
Bielsko-Biala
Boehringer Ingelheim Investigational Site 35
Bielsko-Biala
Boehringer Ingelheim Investigational Site 79
Biskupiec
Boehringer Ingelheim Investigational Site 116
Bochnia
Boehringer Ingelheim Investigational Site 115
Brzesko
Boehringer Ingelheim Investigational Site 138
Brzesko
Boehringer Ingelheim Investigational Site 185
Brzeziny
Boehringer Ingelheim Investigational Site 90
Brzozów
Boehringer Ingelheim Investigational Site 105
Bydgoszcz
Boehringer Ingelheim Investigational Site 119
Bydgoszcz
Boehringer Ingelheim Investigational Site 123
Bydgoszcz
Boehringer Ingelheim Investigational Site 222
Bydgoszcz
Boehringer Ingelheim Investigational Site 27
Bydgoszcz
Boehringer Ingelheim Investigational Site 21
Chełm
Boehringer Ingelheim Investigational Site 22
Chełm
Boehringer Ingelheim Investigational Site 11
Chełmsko Śląskie
Boehringer Ingelheim Investigational Site 233
Chodzież
Boehringer Ingelheim Investigational Site 226
Chojnice
Boehringer Ingelheim Investigational Site 149
Chorzów
Boehringer Ingelheim Investigational Site 153
Chorzów
Boehringer Ingelheim Investigational Site 88
Ciechanów
Boehringer Ingelheim Investigational Site 232
Czarnków
Boehringer Ingelheim Investigational Site 229
Częstochowa
Boehringer Ingelheim Investigational Site 4
Częstochowa
Boehringer Ingelheim Investigational Site 23
Dąbrowa Górnicza
Boehringer Ingelheim Investigational Site 92
Domaradz
Boehringer Ingelheim Investigational Site 246
Dziergowice
Boehringer Ingelheim Investigational Site 133
Gdansk
Boehringer Ingelheim Investigational Site 134
Gdansk
Boehringer Ingelheim Investigational Site 136
Gdansk
Boehringer Ingelheim Investigational Site 155
Gdansk
Boehringer Ingelheim Investigational Site 156
Gdansk
Boehringer Ingelheim Investigational Site 20
Gdansk
Boehringer Ingelheim Investigational Site 234
Gdansk
Boehringer Ingelheim Investigational Site 31
Gdansk
Boehringer Ingelheim Investigational Site 41
Gdynia
Boehringer Ingelheim Investigational Site 217
Gliwice
Boehringer Ingelheim Investigational Site 247
Głuchołazy
Boehringer Ingelheim Investigational Site 243
Gmina Jędrzejów
Boehringer Ingelheim Investigational Site 141
Gmina Końskie
Boehringer Ingelheim Investigational Site 142
Gmina Końskie
Boehringer Ingelheim Investigational Site 73
Gmina Sawin
Boehringer Ingelheim Investigational Site 107
Gmina Śrem
Boehringer Ingelheim Investigational Site 213
Gmina Śrem
Boehringer Ingelheim Investigational Site 181
Gmina Świecie
Boehringer Ingelheim Investigational Site 38
Gmina Uchanie
Boehringer Ingelheim Investigational Site 85
Góra
Boehringer Ingelheim Investigational Site 50
Gorzów Wielkopolski
Boehringer Ingelheim Investigational Site 174
Grodzisk Mazowiecki
Boehringer Ingelheim Investigational Site 176
Grodzisk Mazowiecki
Boehringer Ingelheim Investigational Site 56
Gryfice
Boehringer Ingelheim Investigational Site 179
Jarosław
Boehringer Ingelheim Investigational Site 108
Jasło
Boehringer Ingelheim Investigational Site 225
Jasło
Boehringer Ingelheim Investigational Site 8
Jasło
Boehringer Ingelheim Investigational Site 148
Jelenia Góra
Boehringer Ingelheim Investigational Site 162
Katowice
Boehringer Ingelheim Investigational Site 163
Katowice
Boehringer Ingelheim Investigational Site 164
Katowice
Boehringer Ingelheim Investigational Site 212
Katowice
Boehringer Ingelheim Investigational Site 69
Kcynia
Boehringer Ingelheim Investigational Site 112
Kielce
Boehringer Ingelheim Investigational Site 18
Kielce
Boehringer Ingelheim Investigational Site 19
Kielce
Boehringer Ingelheim Investigational Site 13
Kłodzko
Boehringer Ingelheim Investigational Site 49
Kołobrzeg
Boehringer Ingelheim Investigational Site 219
Konin
Boehringer Ingelheim Investigational Site 51
Koszalin
Boehringer Ingelheim Investigational Site 52
Koszalin
Boehringer Ingelheim Investigational Site 122
Krakow
Boehringer Ingelheim Investigational Site 135
Krakow
Boehringer Ingelheim Investigational Site 143
Krakow
Boehringer Ingelheim Investigational Site 146
Krakow
Boehringer Ingelheim Investigational Site 171
Krakow
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Krakow
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Krakow
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Krakow
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Krakow
Boehringer Ingelheim Investigational Site 129
Kraśnik
Boehringer Ingelheim Investigational Site 204
Kraśnik
Boehringer Ingelheim Investigational Site 207
Kraśnik
Boehringer Ingelheim Investigational Site 192
Krosno
Boehringer Ingelheim Investigational Site 194
Kutno
Boehringer Ingelheim Investigational Site 86
Lędziny
Boehringer Ingelheim Investigational Site 97
Legionowo
Boehringer Ingelheim Investigational Site 127
Liśnik Duży
Boehringer Ingelheim Investigational Site 187
Lodz
Boehringer Ingelheim Investigational Site 188
Lodz
Boehringer Ingelheim Investigational Site 193
Lodz
Boehringer Ingelheim Investigational Site 198
Lodz
Boehringer Ingelheim Investigational Site 206
Lodz
Boehringer Ingelheim Investigational Site 57
Łomża
Boehringer Ingelheim Investigational Site 58
Łomża
Boehringer Ingelheim Investigational Site 186
Lowicz
Boehringer Ingelheim Investigational Site 158
Lubań
Boehringer Ingelheim Investigational Site 37
Lubartów
Boehringer Ingelheim Investigational Site 172
Lubin
Boehringer Ingelheim Investigational Site 173
Lubin
Boehringer Ingelheim Investigational Site 196
Lubin
Boehringer Ingelheim Investigational Site 124
Lublin
Boehringer Ingelheim Investigational Site 17
Lublin
Boehringer Ingelheim Investigational Site 29
Lublin
Boehringer Ingelheim Investigational Site 7
Lublin
Boehringer Ingelheim Investigational Site 242
Lubliniec
Boehringer Ingelheim Investigational Site 209
Luboń
Boehringer Ingelheim Investigational Site 106
Ludwikowo
Boehringer Ingelheim Investigational Site 30
Łuków
Boehringer Ingelheim Investigational Site 45
Maków Mazowiecki
Boehringer Ingelheim Investigational Site 168
Malbork
Boehringer Ingelheim Investigational Site 110
Mielec
Boehringer Ingelheim Investigational Site 159
Milicz
Boehringer Ingelheim Investigational Site 150
Mysłowice
Boehringer Ingelheim Investigational Site 25
Myszków
Boehringer Ingelheim Investigational Site 215
Nisko
Boehringer Ingelheim Investigational Site 128
Nowy Dwór Gdański
Boehringer Ingelheim Investigational Site 109
Nowy Sącz
Boehringer Ingelheim Investigational Site 154
Oława
Boehringer Ingelheim Investigational Site 72
Olecko
Boehringer Ingelheim Investigational Site 36
Olsztyn
Boehringer Ingelheim Investigational Site 245
Opatów
Boehringer Ingelheim Investigational Site 114
Ostrowiec Świętokrzyski
Boehringer Ingelheim Investigational Site 145
Ostrowiec Świętokrzyski
Boehringer Ingelheim Investigational Site 237
Pabianice
Boehringer Ingelheim Investigational Site 182
Papowo Biskupie
Boehringer Ingelheim Investigational Site 216
Pawonków
Boehringer Ingelheim Investigational Site 189
Piekary Śląskie
Boehringer Ingelheim Investigational Site 32
Pietrzykowice
Boehringer Ingelheim Investigational Site 40
Piła
Boehringer Ingelheim Investigational Site 203
Piotrkow Trybunalski
Boehringer Ingelheim Investigational Site 59
Płock
Boehringer Ingelheim Investigational Site 93
Pniewy
Boehringer Ingelheim Investigational Site 130
Poniatowa
Boehringer Ingelheim Investigational Site 201
Poznan
Boehringer Ingelheim Investigational Site 208
Poznan
Boehringer Ingelheim Investigational Site 227
Poznan
Boehringer Ingelheim Investigational Site 228
Poznan
Boehringer Ingelheim Investigational Site 231
Poznan
Boehringer Ingelheim Investigational Site 126
Prabuty
Boehringer Ingelheim Investigational Site 218
Proszowice
Boehringer Ingelheim Investigational Site 131
Pruszcz Gdański
Boehringer Ingelheim Investigational Site 191
Przemyśl
Boehringer Ingelheim Investigational Site 169
Rabka-Zdrój
Boehringer Ingelheim Investigational Site 117
Radom
Boehringer Ingelheim Investigational Site 118
Radom
Boehringer Ingelheim Investigational Site 151
Ruda Śląska
Boehringer Ingelheim Investigational Site 152
Ruda Śląska
Boehringer Ingelheim Investigational Site 230
Ruda Śląska
Boehringer Ingelheim Investigational Site 82
Ruda Śląska
Boehringer Ingelheim Investigational Site 180
Rumia
Boehringer Ingelheim Investigational Site 239
Rumia
Boehringer Ingelheim Investigational Site 5
Rumia
Boehringer Ingelheim Investigational Site 104
Rybnik
Boehringer Ingelheim Investigational Site 183
Rybnik
Boehringer Ingelheim Investigational Site 83
Rybnik
Boehringer Ingelheim Investigational Site 175
Rzeszów
Boehringer Ingelheim Investigational Site 178
Rzeszów
Boehringer Ingelheim Investigational Site 190
Sanok
Boehringer Ingelheim Investigational Site 78
Sejny
Boehringer Ingelheim Investigational Site 160
Siewierz
Boehringer Ingelheim Investigational Site 241
Skarżysko-Kamienna
Boehringer Ingelheim Investigational Site 157
Skawina
Boehringer Ingelheim Investigational Site 10
Skoczów
Boehringer Ingelheim Investigational Site 167
Skrzyszów
Boehringer Ingelheim Investigational Site 53
Sławno
Boehringer Ingelheim Investigational Site 96
Słubice
Boehringer Ingelheim Investigational Site 205
Słupca
Boehringer Ingelheim Investigational Site 14
Sokołowsko
Boehringer Ingelheim Investigational Site 113
Sopot
Boehringer Ingelheim Investigational Site 166
Sosnowiec
Boehringer Ingelheim Investigational Site 24
Sosnowiec
Boehringer Ingelheim Investigational Site 125
Stalowa Wola
Boehringer Ingelheim Investigational Site 144
Starachowice
Boehringer Ingelheim Investigational Site 80
Starachowice
Boehringer Ingelheim Investigational Site 120
Stargard
Boehringer Ingelheim Investigational Site 95
Sucha Beskidzka
Boehringer Ingelheim Investigational Site 16
Supraśl
Boehringer Ingelheim Investigational Site 54
Suwałki
Boehringer Ingelheim Investigational Site 55
Suwałki
Boehringer Ingelheim Investigational Site 1
Świdnik
Boehringer Ingelheim Investigational Site 76
Syców
Boehringer Ingelheim Investigational Site 43
Szczecin
Boehringer Ingelheim Investigational Site 48
Szczecin
Boehringer Ingelheim Investigational Site 61
Szczecin
Boehringer Ingelheim Investigational Site 66
Szczecin
Boehringer Ingelheim Investigational Site 67
Szczecin
Boehringer Ingelheim Investigational Site 26
Szczecinek
Boehringer Ingelheim Investigational Site 111
Tarnobrzeg
Boehringer Ingelheim Investigational Site 224
Tarnobrzeg
Boehringer Ingelheim Investigational Site 139
Tarnów
Boehringer Ingelheim Investigational Site 140
Tarnów
Boehringer Ingelheim Investigational Site 200
Tarnowskie Góry
Boehringer Ingelheim Investigational Site 101
Torun
Boehringer Ingelheim Investigational Site 70
Torun
Boehringer Ingelheim Investigational Site 71
Torun
Boehringer Ingelheim Investigational Site 220
Trzcianka Lubuska
Boehringer Ingelheim Investigational Site 103
Twardogóra
Boehringer Ingelheim Investigational Site 147
Tychy
Boehringer Ingelheim Investigational Site 244
Tychy
Boehringer Ingelheim Investigational Site 39
Wałcz
Boehringer Ingelheim Investigational Site 100
Warsaw
Boehringer Ingelheim Investigational Site 121
Warsaw
Boehringer Ingelheim Investigational Site 137
Warsaw
Boehringer Ingelheim Investigational Site 161
Warsaw
Boehringer Ingelheim Investigational Site 165
Warsaw
Boehringer Ingelheim Investigational Site 210
Warsaw
Boehringer Ingelheim Investigational Site 223
Warsaw
Boehringer Ingelheim Investigational Site 238
Warsaw
Boehringer Ingelheim Investigational Site 2
Warsaw
Boehringer Ingelheim Investigational Site 3
Warsaw
Boehringer Ingelheim Investigational Site 42
Warsaw
Boehringer Ingelheim Investigational Site 46
Warsaw
Boehringer Ingelheim Investigational Site 74
Warsaw
Boehringer Ingelheim Investigational Site 91
Warsaw
Boehringer Ingelheim Investigational Site 99
Warsaw
Boehringer Ingelheim Investigational Site 6
Wejherowo
Boehringer Ingelheim Investigational Site 199
Wieliczna
Boehringer Ingelheim Investigational Site 235
Wieluń
Boehringer Ingelheim Investigational Site 197
Witonia
Boehringer Ingelheim Investigational Site 65
Wloc³awek
Boehringer Ingelheim Investigational Site 28
Wodzisław Śląski
Boehringer Ingelheim Investigational Site 98
Wołomin
Boehringer Ingelheim Investigational Site 102
Wroclaw
Boehringer Ingelheim Investigational Site 202
Wroclaw
Boehringer Ingelheim Investigational Site 221
Wroclaw
Boehringer Ingelheim Investigational Site 62
Wroclaw
Boehringer Ingelheim Investigational Site 63
Wroclaw
Boehringer Ingelheim Investigational Site 64
Wroclaw
Boehringer Ingelheim Investigational Site 89
Wroclaw
Boehringer Ingelheim Investigational Site 12
Ząbkowice Śląskie
Boehringer Ingelheim Investigational Site 9
Ząbkowice Śląskie
Boehringer Ingelheim Investigational Site 68
Zabrze
Boehringer Ingelheim Investigational Site 75
Zabrze
Boehringer Ingelheim Investigational Site 77
Zabrze
Boehringer Ingelheim Investigational Site 60
Zągoty
Boehringer Ingelheim Investigational Site 132
Zblewo
Boehringer Ingelheim Investigational Site 195
Zgierz
Boehringer Ingelheim Investigational Site 15
Zielona Góra
Boehringer Ingelheim Investigational Site 47
Zielona Góra
Boehringer Ingelheim Investigational Site 81
Zielonka k/Warszawy
Boehringer Ingelheim Investigational Site 211
Żyrardów

Other trials in Poland

About this study

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

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Spiriva HandiHaler
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.

Spiriva HandiHalerDrug

What is being measured

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

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.
Measured: Baseline, 3 months

Secondary outcomes (1)

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.
Measured: Baseline, 3 months

Timeline

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

Nov 2011Mar 2013

First posted19 Jul 2012 (estimated)
Study startNov 2011
Primary completionMar 2013
Study completionMar 2013

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.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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 4
Allocation: Not applicable
Intervention model: Single group
Enrolment: 1,328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01644734
Sponsor's protocol ID: 205.502
Status last verified: Apr 2014
First submitted: 17 Jul 2012
Last updated: 26 May 2014
Results posted: Yes, on ClinicalTrials.gov

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

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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MATHS: Assessment of Health-status of Patients With COPD on MAintenance THerapy With Spiriva® HH Measured by CAT Test
ClinicalTrials.gov ID: NCT01644734
Acronym / sponsor ID: 205.502
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,328 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Nov 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 19 Jul 2012 (estimated)
Results: Posted 26 May 2014

Clinical summary

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

Study design

Allocation: Not applicable
Intervention model: Single group

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

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
Spiriva HandiHaler	Drug	–

Primary outcome

Number of Patients Maintaining or Improving Their Health Status
Time frame: Baseline, 3 months
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.

1 secondary outcome

Change in the Total CAT Score (Value Baseline Minus 3 Months)
Time frame: Baseline, 3 months

Results and safety

Results posted to the registry on 26 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Treated With Spiriva HandiHaler	1,282	1,016

Primary outcome: Number of Patients Maintaining or Improving Their Health Status

Time frame: Baseline, 3 months. Number. Unit: participants

Measure	Patients Treated With Spiriva HandiHaler n = 1016
Value	972 (94.2 to 96.8)

Population analysed: Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Average of 92.4 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Treated With Spiriva HandiHaler	0 of 1,282 (0%)	0 of 1,282 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Disease, Chronic Obstructive

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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

247 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Spiriva HandiHaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 247 sites in Poland.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 247 sites in Poland. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 26 May 2014). 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?

Number of Patients Maintaining or Improving Their Health Status (time frame: Baseline, 3 months). 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 NCT01644734.

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 26 May 2014.