Pulmonary Disease, Chronic ObstructivePhase 3NCT00274560
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.
A Phase 3 study testing Tiotropium and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 50 sites in 8 countries.
Trial summary
The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol . Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium and Salmeterol
- How many people
- 653 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 1 May 2002to 27 Mar 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- Ability to sign a written Informed Consent Form consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial (i.e., prior to any study procedures, including any pre-study washout of medications).
- Age of 40 years or older.
- Smoking history of ≥10 pack-years.
- A diagnosis of relatively stable chronic obstructive pulmonary disease with an Forced expiratory volume in one second (FEV1) ≤60% of predicted normal and FEV1 ≤70% of Forced vital capacity (FVC).
- Ability to perform technically acceptable pulmonary function tests, and ability to maintain records during the study period as required in the protocol.
- Ability to inhale medication from the HandiHaler® and from a metered dose inhaler.
Who cannot join
- Clinically significant diseases other than Chronic obstructive pulmonary disease (COPD). A clinically significant disease was defined as a disease or condition which, in the opinion of the investigator, could have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patient's ability to participate in the study.
- Known moderate or severe renal insufficiency.
- A recent history (i.e., six months or less) of myocardial infarction.
- Unstable or life-threatening cardiac arrhythmias, including newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed on Visit 1. Unstable arrhythmias included arrhythmias that required an intervention (i.e., hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the year preceding study enrollment.
- Hospitalization for heart failure during the past three years.
- History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- Other exclusion criteria apply.
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
United States20 sites
University Medical Associates, LLP
Augusta, Georgia
UAB Medical Center
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Boulder, Colorado
Attention: Thomas D. Kaelin, Jr., D.O.
Charleston, South Carolina
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
Colorado Pulmonary Associates
Denver, Colorado
Boehringer Ingelheim Investigational Site
Fullerton, California
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Jasper, Alabama
Boehringer Ingelheim Investigational Site
Melbourne, Florida
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
Temple University School of Medicine
Philadelphia, Pennsylvania
Boehringer Ingelheim Investigational Site
Phoenix, Arizona
The Oregon Clinic
Portland, Oregon
VA Greater Los angeles Health Care Systems
Sepulveda, California
LSU MC-Sheveport
Shreveport, Louisiana
Olive View UCLA Medical Center
Sylmar, California
Southern Arizona VA Health Care System
Tucson, Arizona
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
Sweden7 sites
Lindesbergs lasarett
Lindesberg
Boehringer Ingelheim Investigational Site
Linköping
Vårdcentralen Brinken
Motala
Boehringer Ingelheim Investigational Site
Örebro
Boehringer Ingelheim Investigational Site
Stockholm
Fysiologlaboratoriet
Stockholm
Boehringer Ingelheim Investigational Site
Uppsala
Greece6 sites
Gen. Hosp. "Evangelismos",
Athens
Gen. Hosp. of Chest Diseases "Sotiria"
Athens
Gen. Hosp. of Chest Diseases"Sotiria"
Athens
University Hospital of Ioannina
Ioannina
General Hospital "Sismanoglio", 3rd Pneumonology Dpt
Maroussi, Athens
General Hospital "Papanicolaou",
Thessaloniki
Portugal4 sites
Hospital de Santa Maria
Lisbon
Hospital Pulido Valente
Lisbon
Hospital de São João
Porto
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia
Turkey (Türkiye)4 sites
Gazi Universitesi Tip Fakultesi
Ankara
Istanbul Universitesi Cerrahpasa Tip Fakültesi
Istanbul
Yedikule Gögüs Hastaliklari Hastanesi
Istanbul
Ege Universitesi Tip Fakultesi
Izmir
United Kingdom4 sites
Frenchay Healthcare NHS Trust
Bristol
Boehringer Ingelheim Investigational Site
Glasgow
West Middlesex University Hospital
Isleworth
Medicines Evaluation Unit
Manchester
Finland3 sites
HEMO Oy Health Center
Lahti
Boehringer Ingelheim Investigational Site
Mikkeli
Boehringer Ingelheim Investigational Site
Oulu
About this study
Official title: A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, 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.
TiotropiumDrug
SalmeterolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
Measured: 12 weeks
peak FEV1
Measured: 12 weeks
Secondary outcomes (11)
Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing
Measured: 12 weeks
Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day
Measured: 12 weeks
Individual FEV1 and FVC measurements at each timepoint
Measured: 12 weeks
Number (%) of patients with at least one exacerbation of COPD
Measured: 12 weeks
time to first exacerbation
Measured: 12 weeks
number of exacerbations
Measured: 12 weeks
number of exacerbation days
Measured: 12 weeks
Average daily occasions of rescue medication [albuterol (salbutamol)] use each week
Measured: 12 weeks
All adverse events
Measured: 12 weeks
Pulse rate measured in conjunction with spirometry
Measured: 12 weeks
Blood pressure (seated) measured in conjunction with spirometry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study start1 May 2002
- Primary completion27 Mar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274560
- Sponsor's protocol ID
- 205.264
- Status last verified
- Nov 2023
- First submitted
- 9 Jan 2006
- Last updated
- 1 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00274560
- Acronym / sponsor ID
- 205.264
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 May 2002 (actual)
- Primary completion
- 27 Mar 2003 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to sign a written Informed Consent Form consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial (i.e., prior to any study procedures, including any pre-study washout of medications).
- Age of 40 years or older.
- Smoking history of ≥10 pack-years.
- A diagnosis of relatively stable chronic obstructive pulmonary disease with an Forced expiratory volume in one second (FEV1) ≤60% of predicted normal and FEV1 ≤70% of Forced vital capacity (FVC).
- Ability to perform technically acceptable pulmonary function tests, and ability to maintain records during the study period as required in the protocol.
Key exclusion criteria (7 listed)
- Clinically significant diseases other than Chronic obstructive pulmonary disease (COPD). A clinically significant disease was defined as a disease or condition which, in the opinion of the investigator, could have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patient's ability to participate in the study.
- Known moderate or severe renal insufficiency.
- A recent history (i.e., six months or less) of myocardial infarction.
- Unstable or life-threatening cardiac arrhythmias, including newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed on Visit 1. Unstable arrhythmias included arrhythmias that required an intervention (i.e., hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the year preceding study enrollment.
- Hospitalization for heart failure during the past three years.
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 | Drug | – |
| Salmeterol | Drug | – |
Primary outcome
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
Time frame: 12 weeks
peak FEV1
Time frame: 12 weeks
11 secondary outcomes
Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing
Time frame: 12 weeks
Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day
Time frame: 12 weeks
Individual FEV1 and FVC measurements at each timepoint
Time frame: 12 weeks
Number (%) of patients with at least one exacerbation of COPD
Time frame: 12 weeks
time to first exacerbation
Time frame: 12 weeks
number of exacerbations
Time frame: 12 weeks
number of exacerbation days
Time frame: 12 weeks
Average daily occasions of rescue medication [albuterol (salbutamol)] use each week
Time frame: 12 weeks
All adverse events
Time frame: 12 weeks
Pulse rate measured in conjunction with spirometry
Time frame: 12 weeks
Blood pressure (seated) measured in conjunction with spirometry
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Related InfoLink provided by the sponsor.
- 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 Coordinator study chair
Boehringer Ingelheim
50 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 Tiotropium and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 50 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?
The sponsor lists 6 inclusion and 7 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Sweden, Greece, Portugal, Turkey (Türkiye) 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12) (time frame: 12 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?
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 1 Dec 2023.