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| ID | Type | Description | Link |
|---|---|---|---|
| IIS Boehringer-Ingelheim | Other Grant/Funding Number | Boehringer-Ingelheim and Pfizer | |
| IIS Pfizer | Other Grant/Funding Number | Pfizer |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Pfizer | INDUSTRY |
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We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.
Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium 18 µg capsule, bronchodilator | Active Comparator | tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo |
|
| 2 | Placebo Comparator | placebo 18ug tiotropium for 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)- | Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second | 30 days |
| Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity) | Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients. | 30 days |
| Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo | Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters | 30 days |
| Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo | Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters | 30 days |
| Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo | Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage | 30 days |
| Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo | Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium | Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium | baseline to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur F Gelb, MD | Arthur F Gelb Medical Corporation | Principal Investigator |
| Noe Zamel, MD | Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur F Gelb MD | Lakewood | California | 90712 | United States | ||
| Noe Zamel MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15596684 | Background | Gelb AF, Gutierrez CA, Weisman IM, Newsom R, Taylor CF, Zamel N. Simplified detection of dynamic hyperinflation. Chest. 2004 Dec;126(6):1855-60. doi: 10.1378/chest.126.6.1855. | |
| 17356081 | Background | Gelb AF, Taylor CF, McClean PA, Shinar CM, Rodrigues MT, Gutierrez CA, Chapman KR, Zamel N. Tiotropium and simplified detection of dynamic hyperinflation. Chest. 2007 Mar;131(3):690-695. doi: 10.1378/chest.06-1662. |
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Please see published data
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We recruited 30 patients with smoking history >20 pack yr with documented GOLD Stage 2 moderate COPD who were clinically stable for at least 6 weeks prior to the present study and were not on oxygen or oral corticosteroids.
Patients with COPD (chronic obstructive pulmonary disease), GOLD (Global Initiative for Chronic Obstructive Lung Disease)Stage 2 were recruited from pulmonary out-patient offices at Mt. Sinai Hosp. Toronto and from Arthur F Gelb MD Lakewood, Calif from June 2009 thru January 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium 18 µg Capsule First, Then Placebo | tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo |
| FG001 | Placebo First, Then Tiotropium Bromide 18 µg | tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period: First Intervention |
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| Period: Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive placebo first and Tiotropium first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)- | Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second | Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
|
6 months
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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 | Tiotropium Bromide 18 µg, Capsule, | tiotropium 18 µg capsule for 1 month. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium. (30 enrolled subjects, one drop-out) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur F Gelb MD Principal Investigator | Arthur F Gelb MD | 562-633-2204 | afgelb@msn.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 30 days |
| Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo | Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters) | 30 days |
| Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo | Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters) | 30 days |
| Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo | Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | 30 days |
| Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo | Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters | 30 days |
| Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo | Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage | 30 days |
| Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo | Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | 30 days |
| IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline | IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo | baseline and 30 days (+2h) post dose |
| TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo | Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium | one hour before intervention & 2 hrs. after after 30 days |
| IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema | Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema | baseline to 30 days |
| Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium | Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema | baseline to trough tiotropium |
| Toronto |
| Ontario |
| Canada |
| 21159499 | Derived | Gelb AF, Fraser C, Zamel N. Lack of protective effect of tiotropium vs induced dynamic hyperinflation in moderate COPD. Respir Med. 2011 May;105(5):755-60. doi: 10.1016/j.rmed.2010.11.020. Epub 2010 Dec 14. |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Average participant age +/- SD | One patient was dropped due to a protocol violation. | Mean | Standard Deviation | years |
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| FVC (forced vital capacity) | forced vital capacity (observed) | Mean | Standard Deviation | liters |
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| FVC | Forced vital capacity - % predicted | Mean | Standard Deviation | percentage of liters expected |
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| FEV1(L) (forces expiratory volume) observed | Forced expiratory volume in 1s, observed | Mean | Standard Deviation | liters |
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| FEV1 (L) percent predicted | forced vital capacity (L) - percent predicted | Mean | Standard Deviation | percentage of liters expected |
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| FEV1/FVC percentage | forced expiratory volume in 1s/forced vital capacity - percent | Mean | Standard Deviation | percentage of liters expected |
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| SGaw (Lps/cmH2O/L) (specific airway conductance) | specific airway conductance (observed) | Mean | Standard Deviation | Lps/cmH2O/L |
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| FRC (L) (functional residual capacity) observed | functional residual capacity - observed | Mean | Standard Deviation | liters |
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| FRC percent of liters predicted | functional residual capacity percent of liters predicted | Mean | Standard Deviation | percentage of liters predicted |
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| RV (L) (residual volume) observed | residual volume (liters) observed | Mean | Standard Deviation | liters |
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| RV (L) - % predicted | residual volume (L) - percent predicted | Mean | Standard Deviation | percentage |
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| TLC (L) (total lung capacity) observed | total lung capacity - observed | Mean | Standard Deviation | liters |
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| TLC Percent of liters predicted | total lung capacity - percent of liters predicted | Mean | Standard Deviation | percentage of liters predicted |
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| D(L)CO(SB) - ml/min/mmHg observed (Single-breath diffusing capacity ) | Single-breath diffusing capacity (ml/min/mmHg)observed | Mean | Standard Deviation | ml/min/mmHg |
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| D(L)CO(SB) - ml/min/mmHg % predicted | single-breath diffusing capacity - ml/min/mmHg - percent predicted | Mean | Standard Deviation | ml/min/mmHg |
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| Secondary | Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium | Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium | High-resolution, thin-section scans of the lung were obtained from a subset of 19 patients. | Posted | Aug 2011 | Mean | Standard Deviation | percentage of lung tissue | baseline to 30 days |
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| Primary | Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity) | Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients. | Includes groups randomized to receive placebo first and Tiotropium first. | Posted | Aug 2011 | Mean | Standard Deviation | Liters | 30 days |
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| Primary | Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo | Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters | Peak FVC after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Secondary | IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema | Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema | Analysis was carried out per protocol | Posted | Mean | Standard Deviation | percentage of lung tissue | baseline to 30 days |
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| Primary | Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo | Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters | Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo | Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage | Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage | Posted | Aug 2011 | Mean | Standard Deviation | percentage of FRC/TLC | 30 days |
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| Primary | Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo | Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters | Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo | Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters) | Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo | Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters) | Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters) | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo | Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo | Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters | Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo | Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage | Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage | Posted | Aug 2011 | Mean | Standard Deviation | percentage of FRC/TLC | 30 days |
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| Primary | Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo | Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients | Posted | Aug 2011 | Mean | Standard Deviation | liters | 30 days |
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| Primary | IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline | IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo | Inspiratory capacity (IC) (mean +/- SD) from baseline and after 30 days of tiotropium versus placebo in 29 moderate COPD patients. | Posted | Jul 2011 | Mean | Standard Deviation | liters | baseline and 30 days (+2h) post dose |
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| Primary | TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo | Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium | lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. | Posted | Jul 2011 | Mean | Standard Deviation | liters | one hour before intervention & 2 hrs. after after 30 days |
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| Secondary | Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium | Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema | High resolution, thin-section scans of the lung were obtained in a subset of 19 patients. | Posted | Mean | Standard Deviation | percentage of lung tissue | baseline to trough tiotropium |
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | Adverse events after placebo. (30 enrolled subjects, one drop-out) | 0 | 30 | 0 | 30 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Tiotropium IC |
|