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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18 mcg tiotropium | Active Comparator | Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler |
|
| Placebo | Placebo Comparator | Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler |
|
| Control | No Intervention | Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | double blind randomized crossover |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Inspiratory Capacity (IC) at Isotime | Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate. | baseline, six weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Work Rate (CWR) Endurance Time | CWR exercise duration calculated as the length of time of the exercise period | six weeks of treatment |
| Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime |
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Inclusion criteria:
For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.
Exclusion criteria:
Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.
Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 205.440.1006 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| 205.440.1015 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26775292 | Derived | Porszasz J, Blonshine S, Cao R, Paden HA, Casaburi R, Rossiter HB. Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulm Med. 2016 Jan 16;16:13. doi: 10.1186/s12890-016-0174-8. | |
| 25906326 | Derived | Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015. |
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The study has two stages, in the first (exploratory) stage, the Control group (Healthy volunteer) is compared to the age-gender matched COPD patients in terms of baseline characteristics. In the second (confirmatory) stage, Placebo and Tiotropium are compared using a cross-over. Since the first stage is exploratory it is not reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Tiotropium | Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks |
| FG001 | Tiotropium/Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period One |
|
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| Placebo |
| Drug |
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder |
|
Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).
| baseline, six weeks of treatment |
| Jasper |
| Alabama |
| United States |
| 205.440.1002 Boehringer Ingelheim Investigational Site | Torrance | California | United States |
| 205.440.1018 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | United States |
| 205.440.1008 Boehringer Ingelheim Investigational Site | Springfield | Illinois | United States |
| 205.440.1017 Boehringer Ingelheim Investigational Site | Muncie | Indiana | United States |
| 205.440.1020 Boehringer Ingelheim Investigational Site | Livonia | Michigan | United States |
| 205.440.1011 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | United States |
| 205.440.1019 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States |
| 205.440.1013 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States |
| 205.440.1007 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| 205.440.2003 Boehringer Ingelheim Investigational Site | Kingston | Ontario | Canada |
| 205.440.2001 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 205.440.2004 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 205.440.2002 Boehringer Ingelheim Investigational Site | Ste-Foy | Quebec | Canada |
| 25289942 | Derived | Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, Paden HA, O'Donnell DE; 205.440 Investigators. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Nov;11(9):1351-61. doi: 10.1513/AnnalsATS.201404-174OC. |
| 24788342 | Derived | O'Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, Iqbal A, Paden HA, Casaburi R; 205.440 investigators. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PLoS One. 2014 May 1;9(5):e96574. doi: 10.1371/journal.pone.0096574. eCollection 2014. |
Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
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| NOT COMPLETED |
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| Washout Period |
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| Period Two |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Tiotropium | Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks |
| BG001 | Tiotropium/Placebo | Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Smoking Status | Number | Participants |
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| Smoking history | Mean | Standard Deviation | pack years |
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| Duration of COPD (Chronic Obstructive Pulmonary Disease) | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Inspiratory Capacity (IC) at Isotime | Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate. | Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint. | Posted | Least Squares Mean | Standard Error | liter | baseline, six weeks of treatment |
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| Secondary | Constant Work Rate (CWR) Endurance Time | CWR exercise duration calculated as the length of time of the exercise period | Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint. | Posted | Least Squares Mean | Standard Error | seconds | six weeks of treatment |
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| Secondary | Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime | Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced). | Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint. | Posted | Least Squares Mean | Standard Error | Scores on a scale | baseline, six weeks of treatment |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients who received placebo in period one or period two | 2 | 123 | 0 | 123 | ||
| EG001 | Tiotropium | Patients who received tiotropium in period one or period two | 1 | 121 | 0 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MeDRA Version 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA Version 14.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 14.1 | Systematic Assessment |
| |
| Lentigo maligna stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 14.1 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| >55 to <=65 years |
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| >65 years |
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| Male |
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| White |
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| Currently smokes |
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