Pulmonary Disease, Chronic ObstructivePhase 4NCT00530842

Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

A Phase 4 study testing Tiotropium plus Salmeterol and Fluticasone/Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 42 sites in 7 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 primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium plus Salmeterol and Fluticasone/Salmeterol
How many people: 344 participants
Where: 42 sitesin 7 countries
Study dates: Sep 2007to Jan 2009
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient has signed an Informed Consent Form in accordance with GCP and local legislative requirements prior to participation in the trial, i.e., prior to pre-trial washout of any restricted medications.
The patient has a clinical diagnosis of chronic obstructive pulmonary disease (COPD).
The patient has relatively stable, moderate to severe airway obstruction.
The patient has a pre-bronchodilator forced expiratory volume in the first second (FEV1) less than or equal to 65% of predicted normal determined at Visit 1 using the following predicted equations (R94-1408):
Males Forced expiratory volume in the first second (FEV1) predicted [Litres (L)] = 4.30 x Height [metres] minus 0.029 x Age [years] minus 2.49
Females Forced expiratory volume in the first second (FEV1) predicted [Litres (L)] = 3.95 x Height [metres] minus 0.025 x Age [years] minus 2.60 and a Thoracic Gas Volume (Functional residual volume) ((TGV)(FRC)) bigger than 120% predicted normal at visit 1 (or historical data not older than 6 month)

Show all 13Show fewer

Males Thoracic Gas Volume (Functional residual volume) ((TGV(FRC)) pred. [Litres (L)] = 2.34 x Height [metres] + 0.009 x Age [years] minus 1.09
Females Thoracic Gas Volume (Functional residual volume) ((TGV(FRC)) pred. [Litres (L)] = 2.24 x Height [metres] + 0.001 x Age [years] minus 1.00
The patient is at least 40 years and less than or equal to 75 years old.
The patient has a cigarette smoking history of at least 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
The patient is able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol.
The patient is able to inhale the trial medication from the HandiHaler device.
The patient is able to inhale the trial medication from the Diskus/Accuhaler device.

Who cannot join

a significant disease other than chronic obstructive pulmonary disease (COPD). (review contraindications for exercise testing),
a recent history of myocardial infarction within one year.
a recent history of heart failure, pulmonary oedema, or patients with cardiac arrhythmia or any contraindication to exercise described in the CTProtocol within the last 3.
daytime supplemental oxygen.
a diagnosis of known active tuberculosis.
a history of cancer within the last 5 years.

Show all 28Show fewer

a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
thoracotomy with pulmonary resection.
an upper respiratory tract infection or an exacerbation of chronic obstructive pulmonary disease (COPD)
a known hypersensitivity to anticholinergic drug, ß-adrenergic or corticosteroids, lactose or any other component of the inhalation capsule delivery system.
a known symptomatic prostatic hypertrophy or bladder neck obstruction.
a known moderate or severe renal insufficiency.
a known narrow-angle glaucoma.
a known untreated hypokalemia.
a known untreated thyrotoxicosis.
a history of asthma, allergic rhinitis or atopy, or a total blood eosinophil count larger than 600/mm3.
treatment with cromolyn sodium or nedocromil sodium
treatment with antihistamines or antileukotrienes.
treatment with tiotropium for 1 month before Visit 1.
treatment with oral corticosteroid medication.
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
a history of or active alcohol or drug abuse.
an investigational drug within 1 month or 10 half lives
a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea.
participation in a rehabilitation program for chronic obstructive pulmonary disease (COPD).
treatment with monoamine oxidase inhibitors inhibitors or tricyclic antidepressants.
participation in another study.
more than eight puffs of salbutamol/day during the run-in period

Trial locations and contacts

42 sites in 7 countries.

Country

City, postcode or hospital

42 sites in 7 countries

Canada9 sites

205.334.1003 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
205.334.1005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
205.334.1008 Boehringer Ingelheim Investigational Site
Kingston, Ontario
205.334.1001 Boehringer Ingelheim Investigational Site
Montreal, Quebec
205.334.1004 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
205.334.1006 Boehringer Ingelheim Investigational Site
Québec, Quebec
205.334.1007 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
205.334.1010 Boehringer Ingelheim Investigational Site
Toronto, Ontario
205.334.1009 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

France9 sites

205.334.3303A Boehringer Ingelheim Investigational Site
Beuvry
205.334.3303B Boehringer Ingelheim Investigational Site
Beuvry
205.334.3305A Boehringer Ingelheim Investigational Site
Créteil
205.334.3301A Boehringer Ingelheim Investigational Site
Grenoble
205.334.3304A Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez
205.334.3306A Boehringer Ingelheim Investigational Site
Strasbourg
205.334.3306B Boehringer Ingelheim Investigational Site
Strasbourg
205.334.3302A Boehringer Ingelheim Investigational Site
Toulouse
205.334.3302B Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

Austria6 sites

205.334.4309 Boehringer Ingelheim Investigational Site
Gänserndorf
205.334.4308 Boehringer Ingelheim Investigational Site
Hallein
205.334.4306 Boehringer Ingelheim Investigational Site
Leoben
205.334.4301 Boehringer Ingelheim Investigational Site
Linz
205.334.4302 Boehringer Ingelheim Investigational Site
Neumarkt am Wallersee
205.334.4305 Boehringer Ingelheim Investigational Site
Salzburg

Other trials in Austria

Germany6 sites

205.334.4908 Boehringer Ingelheim Investigational Site
Berlin
205.334.4909 Boehringer Ingelheim Investigational Site
Berlin
205.334.4902 Boehringer Ingelheim Investigational Site
Cologne
205.334.4904 Boehringer Ingelheim Investigational Site
Donaustauf
205.334.4901 Boehringer Ingelheim Investigational Site
Großhansdorf
205.334.4907 Boehringer Ingelheim Investigational Site
Kiel

Other trials in Germany

Italy6 sites

205.334.39007 Boehringer Ingelheim Investigational Site
Catania
205.334.39002 Boehringer Ingelheim Investigational Site
Gaiato Pavullo (mo)
205.334.39004 Boehringer Ingelheim Investigational Site
Milan
205.334.39001 Boehringer Ingelheim Investigational Site
Pisa
205.334.39005 Boehringer Ingelheim Investigational Site
Roma
205.334.39006 Boehringer Ingelheim Investigational Site
Roma

Other trials in Italy

Russia3 sites

205.334.7001 Boehringer Ingelheim Investigational Site
Moscow
205.334.7002 Boehringer Ingelheim Investigational Site
Moscow
205.334.7003 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Sweden3 sites

205.334.46003 Boehringer Ingelheim Investigational Site
Jönköping
205.334.46002 Boehringer Ingelheim Investigational Site
Lund
205.334.46001 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

About this study

Official title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).

The secondary objective includes assessment of safety.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium plus Salmeterol, Fluticasone/Salmeterol
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.

Tiotropium plus SalmeterolDrug
Fluticasone/SalmeterolDrug

What is being measured

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

Post-dose TGV(FRC) (After 8 Weeks)
Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks
Measured: 8 weeks
Endurance Time (After 8 Weeks)
Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)
Measured: 8 weeks

Secondary outcomes (57)

Post-dose TGV(FRC) (After 4 Weeks)
Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks
Measured: 4 weeks
Endurance Time (After 4 Weeks)
Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)
Measured: 4 weeks
Static Lung Volumes
Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes
Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes
Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes (Percent)
Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes (Percent)
Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes (Percent)
Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes (Percent)
Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes (Percent)
Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes (Percent)
Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Static Lung Volumes (Percent)
Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)
Measured: 8 weeks
Static Lung Volumes (Percent)
Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)
Measured: 4 weeks
Slow Vital Capacity (SVC)
Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)
Measured: 8 weeks
Slow Vital Capacity (SVC)
Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)
Measured: 4 weeks
Slow Vital Capacity (SVC)
Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)
Measured: 8 weeks
Slow Vital Capacity (SVC)
Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)
Measured: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)
Measured: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)
Measured: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)
Measured: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)
Measured: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)
Measured: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)
Measured: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)
Measured: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)
Measured: 4 weeks
Forced Vital Capacity (FVC)
Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Measured: 8 weeks
Forced Vital Capacity (FVC)
Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Measured: 4 weeks
Forced Vital Capacity (FVC)
Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Measured: 8 weeks
Forced Vital Capacity (FVC)
Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Measured: 4 weeks
FEV1 Over FVC (Percent)
Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Measured: 8 weeks
FEV1 Over FVC (Percent)
Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Measured: 4 weeks
FEV1 Over FVC (Percent)
Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)
Measured: 8 weeks
FEV1 Over FVC (Percent)
Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)
Measured: 4 weeks
Symptom Intensity During Exercise
Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea
Measured: 8 weeks
Symptom Intensity During Exercise
Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea
Measured: 4 weeks
Symptom Intensity During Exercise
Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort
Measured: 8 weeks
Symptom Intensity During Exercise
Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort
Measured: 4 weeks
Dyspnea and Leg Discomfort
Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)
Measured: 8 weeks
Dyspnea and Leg Discomfort
Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)
Measured: 8 weeks
Locus of Symptom Limitation at Peak Exercise During Exercise
Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)
Measured: baseline
Locus of Symptom Limitation at Peak Exercise During Exercise
Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)
Measured: 4 weeks
Locus of Symptom Limitation at Peak Exercise During Exercise
Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)
Measured: 8 weeks

Timeline

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

Sep 2007Jan 2009

First posted18 Sep 2007 (estimated)
Study startSep 2007
Primary completionJan 2009

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 (1)Papers the sponsor has linked to this study.
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
Primary purpose: Treatment
Intervention model: Crossover
Enrolment: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00530842
Sponsor's protocol ID: 205.334
Status last verified: Sep 2013
First submitted: 17 Sep 2007
Last updated: 24 Dec 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.
PubMed 22749044

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?

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
ClinicalTrials.gov ID: NCT00530842
Acronym / sponsor ID: 205.334
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jan 2009 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 10 Mar 2010

Clinical summary

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

The secondary objective includes assessment of safety.

Study design

Primary purpose: Treatment
Intervention model: Crossover

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

The patient has signed an Informed Consent Form in accordance with GCP and local legislative requirements prior to participation in the trial, i.e., prior to pre-trial washout of any restricted medications.
The patient has a clinical diagnosis of chronic obstructive pulmonary disease (COPD).
The patient has relatively stable, moderate to severe airway obstruction.
The patient has a pre-bronchodilator forced expiratory volume in the first second (FEV1) less than or equal to 65% of predicted normal determined at Visit 1 using the following predicted equations (R94-1408):
The patient is at least 40 years and less than or equal to 75 years old.

Key exclusion criteria (28 listed)

a significant disease other than chronic obstructive pulmonary disease (COPD). (review contraindications for exercise testing),
a recent history of myocardial infarction within one year.
a recent history of heart failure, pulmonary oedema, or patients with cardiac arrhythmia or any contraindication to exercise described in the CTProtocol within the last 3.
daytime supplemental oxygen.
a diagnosis of known active tuberculosis.

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
Tiotropium plus Salmeterol	Drug	–
Fluticasone/Salmeterol	Drug	–

Primary outcome

Post-dose TGV(FRC) (After 8 Weeks)
Time frame: 8 weeks
Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks
Endurance Time (After 8 Weeks)
Time frame: 8 weeks
Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)

57 secondary outcomes

Post-dose TGV(FRC) (After 4 Weeks)
Time frame: 4 weeks
Endurance Time (After 4 Weeks)
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes
Time frame: 8 weeks
Static Lung Volumes
Time frame: 4 weeks
Static Lung Volumes (Percent)
Time frame: 8 weeks
Static Lung Volumes (Percent)
Time frame: 4 weeks
Static Lung Volumes (Percent)
Time frame: 8 weeks
Static Lung Volumes (Percent)
Time frame: 4 weeks
Static Lung Volumes (Percent)
Time frame: 8 weeks
Static Lung Volumes (Percent)
Time frame: 4 weeks
Static Lung Volumes (Percent)
Time frame: 8 weeks
Static Lung Volumes (Percent)
Time frame: 4 weeks
Slow Vital Capacity (SVC)
Time frame: 8 weeks
Slow Vital Capacity (SVC)
Time frame: 4 weeks
Slow Vital Capacity (SVC)
Time frame: 8 weeks
Slow Vital Capacity (SVC)
Time frame: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 4 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 8 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 10 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tiotropium + Salmeterol / Fluticasone + Salmeterol	172	149
Fluticasone + Salmeterol / Tiotropium + Salmeterol	172	151

Primary outcome: Post-dose TGV(FRC) (After 8 Weeks)

Time frame: 8 weeks. Mean (Standard Error). Unit: Litres

Measure	Tiotropium + Salmeterol n = 309	Fluticasone + Salmeterol n = 309
Value	4.99 (0.07)	5.07 (0.07)

Tiotropium + Salmeterol vs Fluticasone + Salmeterol: Mean Difference (Final Values): -0.087 (95% CI -0.174 to -0.001), p = 0.0482, ANOVA

Population analysed: FAS using imputed values. The full analysis set (FAS) was defined to include all treated patients with any post-dosing efficacy data after at least 4 weeks for both investigational treatments in TGV(FRC) or endurance time.

Primary outcome: Endurance Time (After 8 Weeks)

Time frame: 8 weeks. Median (Inter-Quartile Range). Unit: Seconds

Measure	Tiotropium + Salmeterol n = 309	Fluticasone + Salmeterol n = 309
Value	463 (375)	453 (413)

Tiotropium + Salmeterol vs Fluticasone + Salmeterol: Median Difference (Final Values): 3.0 (95% CI -9.5 to 27.5), p = 0.3407, Wilcoxon signed-rank test

Population analysed: FAS using imputed values

57 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of second treatment period plus 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium + Salmeterol (Period 1)	7 of 172 (4.1%)	18 of 172 (10.5%)	Not reported
Tiotropium + Salmeterol (Period 2)	5 of 160 (3.1%)	18 of 160 (11.3%)	Not reported
Fluticasone + Salmeterol (Period 1)	4 of 172 (2.3%)	21 of 172 (12.2%)	Not reported
Fluticasone + Salmeterol (Period 2)	4 of 157 (2.5%)	12 of 157 (7.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22749044Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

42 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium plus Salmeterol and Fluticasone/Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 42 sites in 7 countries.

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 13 inclusion and 28 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Canada, France, Austria, Germany, Italy and 2 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. 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 10 Mar 2010). 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?

Post-dose TGV(FRC) (After 8 Weeks) (time frame: 8 weeks). 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 NCT00530842, which also lists 1 linked publication.

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 24 Dec 2013.