Improvements in Symptom-Limited Exercise Performance Over 8 h With Once-Daily Tiotropium in Patients With COPD
We have previously shown that tiotropium at 18 μg reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD. The present study was designed to gain further insight into the duration of improvements. A randomized, double-blind, placebo-controlled, p...
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| Veröffentlicht in: | Chest 2005-09, Vol.128 (3), p.1168-1178 |
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| creator | Maltais, François Hamilton, Alan Marciniuk, Darcy Hernandez, Paul Sciurba, Frank C. Richter, Kai Kesten, Steven O’Donnell, Denis |
| description | We have previously shown that tiotropium at 18 μg reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD. The present study was designed to gain further insight into the duration of improvements.
A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 261 COPD patients (mean age, 62.5 ± 7.4 years [± SD]; 189 men and 72 women; mean FEV1, 1.2 ± 0.4 L [43 ± 12.7% predicted]). On day 0 (first dose), day 21, and day 42 of treatment, pulmonary function tests were performed before and 1 h 20 min after dosing, followed by a constant work rate cycle ergometry test (75% maximum work capacity) to symptom limitation at 2.25 h after dosing. On day 42, an additional constant work rate cycle ergometry test was performed at 8 h after dosing.
Adjusted mean (± SE) endurance time (ET) on day 42 was 803 ± 40 s (tiotropium), vs 568 ± 42 s (placebo) at 2.25 h after dosing (primary end point; treatment difference, 236 ± 58 s; p = 0.0001) and 665 ± 40 s (tiotropium) vs 494 ± 42 s (placebo) at 8 h after dosing (treatment difference, 171 ± 58 s; p = 0.0035). Adjusted mean dyspnea intensity at isotime on day 42 was 4.60 ± 0.16 Borg units (tiotropium), vs 5.65 ± 0.16 Borg units (placebo) at 2.25 h after dosing (p < 0.001), and 5.54 ± 0.17 Borg units (tiotropium) vs 6.51 ± 0.18 Borg units (placebo) at 8 h after dosing (p < 0.001). Adjusted mean pre-exercise inspiratory capacity (IC) on day 42 was 2.41 ± 0.03 L (tiotropium) vs 2.19 ± 0.03 L (placebo) at 2.25 h after dosing (p < 0.001), and 2.31 ± 0.03 L (tiotropium) vs 2.16 ± 0.03 L (placebo) at 8 h after dosing (p < 0.001). The significant increase in IC with tiotropium compared with placebo was maintained throughout exercise.
The present study confirms that tiotropium reduces lung hyperinflation at rest and during exercise, reduces exertional dyspnea, and improves symptom-limited exercise tolerance in COPD patients. Furthermore, this study shows that this improvement is present at 2.25 h and at 8 h after dosing after 6 weeks of treatment. |
| doi_str_mv | 10.1378/chest.128.3.1168 |
| format | Article |
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A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 261 COPD patients (mean age, 62.5 ± 7.4 years [± SD]; 189 men and 72 women; mean FEV1, 1.2 ± 0.4 L [43 ± 12.7% predicted]). On day 0 (first dose), day 21, and day 42 of treatment, pulmonary function tests were performed before and 1 h 20 min after dosing, followed by a constant work rate cycle ergometry test (75% maximum work capacity) to symptom limitation at 2.25 h after dosing. On day 42, an additional constant work rate cycle ergometry test was performed at 8 h after dosing.
Adjusted mean (± SE) endurance time (ET) on day 42 was 803 ± 40 s (tiotropium), vs 568 ± 42 s (placebo) at 2.25 h after dosing (primary end point; treatment difference, 236 ± 58 s; p = 0.0001) and 665 ± 40 s (tiotropium) vs 494 ± 42 s (placebo) at 8 h after dosing (treatment difference, 171 ± 58 s; p = 0.0035). Adjusted mean dyspnea intensity at isotime on day 42 was 4.60 ± 0.16 Borg units (tiotropium), vs 5.65 ± 0.16 Borg units (placebo) at 2.25 h after dosing (p < 0.001), and 5.54 ± 0.17 Borg units (tiotropium) vs 6.51 ± 0.18 Borg units (placebo) at 8 h after dosing (p < 0.001). Adjusted mean pre-exercise inspiratory capacity (IC) on day 42 was 2.41 ± 0.03 L (tiotropium) vs 2.19 ± 0.03 L (placebo) at 2.25 h after dosing (p < 0.001), and 2.31 ± 0.03 L (tiotropium) vs 2.16 ± 0.03 L (placebo) at 8 h after dosing (p < 0.001). The significant increase in IC with tiotropium compared with placebo was maintained throughout exercise.
The present study confirms that tiotropium reduces lung hyperinflation at rest and during exercise, reduces exertional dyspnea, and improves symptom-limited exercise tolerance in COPD patients. Furthermore, this study shows that this improvement is present at 2.25 h and at 8 h after dosing after 6 weeks of treatment.</description><identifier>ISSN: 0012-3692</identifier><identifier>EISSN: 1931-3543</identifier><identifier>DOI: 10.1378/chest.128.3.1168</identifier><identifier>PMID: 16162703</identifier><identifier>CODEN: CHETBF</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; bronchodilator agents ; Bronchodilator Agents - pharmacology ; Bronchodilator Agents - therapeutic use ; COPD ; Double-Blind Method ; dyspnea ; Exercise Test ; exercise tolerance ; Exercise Tolerance - drug effects ; Female ; Humans ; inspiratory capacity ; Male ; Pulmonary Disease, Chronic Obstructive - drug therapy ; Respiratory Function Tests ; Scopolamine Derivatives - pharmacology ; Scopolamine Derivatives - therapeutic use ; Time Factors ; tiotropium ; Tiotropium Bromide ; Treatment Outcome</subject><ispartof>Chest, 2005-09, Vol.128 (3), p.1168-1178</ispartof><rights>2005 The American College of Chest Physicians</rights><rights>Copyright American College of Chest Physicians Sep 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c416t-57253d43061cc2ce13cf8b66ae565549bba419b6165b664674455c947aeca9a3</citedby><cites>FETCH-LOGICAL-c416t-57253d43061cc2ce13cf8b66ae565549bba419b6165b664674455c947aeca9a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27926,27927</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16162703$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maltais, François</creatorcontrib><creatorcontrib>Hamilton, Alan</creatorcontrib><creatorcontrib>Marciniuk, Darcy</creatorcontrib><creatorcontrib>Hernandez, Paul</creatorcontrib><creatorcontrib>Sciurba, Frank C.</creatorcontrib><creatorcontrib>Richter, Kai</creatorcontrib><creatorcontrib>Kesten, Steven</creatorcontrib><creatorcontrib>O’Donnell, Denis</creatorcontrib><title>Improvements in Symptom-Limited Exercise Performance Over 8 h With Once-Daily Tiotropium in Patients With COPD</title><title>Chest</title><addtitle>Chest</addtitle><description>We have previously shown that tiotropium at 18 μg reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD. The present study was designed to gain further insight into the duration of improvements.
A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 261 COPD patients (mean age, 62.5 ± 7.4 years [± SD]; 189 men and 72 women; mean FEV1, 1.2 ± 0.4 L [43 ± 12.7% predicted]). On day 0 (first dose), day 21, and day 42 of treatment, pulmonary function tests were performed before and 1 h 20 min after dosing, followed by a constant work rate cycle ergometry test (75% maximum work capacity) to symptom limitation at 2.25 h after dosing. On day 42, an additional constant work rate cycle ergometry test was performed at 8 h after dosing.
Adjusted mean (± SE) endurance time (ET) on day 42 was 803 ± 40 s (tiotropium), vs 568 ± 42 s (placebo) at 2.25 h after dosing (primary end point; treatment difference, 236 ± 58 s; p = 0.0001) and 665 ± 40 s (tiotropium) vs 494 ± 42 s (placebo) at 8 h after dosing (treatment difference, 171 ± 58 s; p = 0.0035). Adjusted mean dyspnea intensity at isotime on day 42 was 4.60 ± 0.16 Borg units (tiotropium), vs 5.65 ± 0.16 Borg units (placebo) at 2.25 h after dosing (p < 0.001), and 5.54 ± 0.17 Borg units (tiotropium) vs 6.51 ± 0.18 Borg units (placebo) at 8 h after dosing (p < 0.001). Adjusted mean pre-exercise inspiratory capacity (IC) on day 42 was 2.41 ± 0.03 L (tiotropium) vs 2.19 ± 0.03 L (placebo) at 2.25 h after dosing (p < 0.001), and 2.31 ± 0.03 L (tiotropium) vs 2.16 ± 0.03 L (placebo) at 8 h after dosing (p < 0.001). The significant increase in IC with tiotropium compared with placebo was maintained throughout exercise.
The present study confirms that tiotropium reduces lung hyperinflation at rest and during exercise, reduces exertional dyspnea, and improves symptom-limited exercise tolerance in COPD patients. Furthermore, this study shows that this improvement is present at 2.25 h and at 8 h after dosing after 6 weeks of treatment.</description><subject>Aged</subject><subject>bronchodilator agents</subject><subject>Bronchodilator Agents - pharmacology</subject><subject>Bronchodilator Agents - therapeutic use</subject><subject>COPD</subject><subject>Double-Blind Method</subject><subject>dyspnea</subject><subject>Exercise Test</subject><subject>exercise tolerance</subject><subject>Exercise Tolerance - drug effects</subject><subject>Female</subject><subject>Humans</subject><subject>inspiratory capacity</subject><subject>Male</subject><subject>Pulmonary Disease, Chronic Obstructive - drug therapy</subject><subject>Respiratory Function Tests</subject><subject>Scopolamine Derivatives - pharmacology</subject><subject>Scopolamine Derivatives - therapeutic use</subject><subject>Time Factors</subject><subject>tiotropium</subject><subject>Tiotropium Bromide</subject><subject>Treatment Outcome</subject><issn>0012-3692</issn><issn>1931-3543</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kd2LEzEUxYMobnf13ScJPvg2NZl8zMQ36a7rQqEFCz6GTObWyTKZ1GSma_970w9YFHwKuZzz495zEHpHyZyyqv5kO0jjnJb1nM0plfULNKOK0YIJzl6iGSG0LJhU5RW6TumR5D9V8jW6opLKsiJshoYHv4thDx6GMWE34O8HvxuDL5bOuxFafPcbonUJ8BriNkRvBgt4tYeIa9zhH27s8CqPilvj-gPeuDDGsHOTP7LWZnQn7km2WK1v36BXW9MneHt5b9Dm691m8a1Yru4fFl-WheVUjoWoSsFazoik1pYWKLPbupHSgJBCcNU0hlPV5CtEnnJZcS6EVbwyYI0y7AZ9PGPzbb-mnJH2LlnoezNAmJKWtaiUqGkWfvhH-BimOOTVdEkI50ydROQssjGkFGGrd9F5Ew-aEn3sQZ960LkHzfSxh2x5f-FOjYf22XAJ_pnZuZ_dk4ugkzd9n-XsTLvs8Rfz89kCObi9g6iTzfFaaLPdjroN7v8L_QE9VKjC</recordid><startdate>20050901</startdate><enddate>20050901</enddate><creator>Maltais, François</creator><creator>Hamilton, Alan</creator><creator>Marciniuk, Darcy</creator><creator>Hernandez, Paul</creator><creator>Sciurba, Frank C.</creator><creator>Richter, Kai</creator><creator>Kesten, Steven</creator><creator>O’Donnell, Denis</creator><general>Elsevier Inc</general><general>American College of Chest Physicians</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20050901</creationdate><title>Improvements in Symptom-Limited Exercise Performance Over 8 h With Once-Daily Tiotropium in Patients With COPD</title><author>Maltais, François ; Hamilton, Alan ; Marciniuk, Darcy ; Hernandez, Paul ; Sciurba, Frank C. ; Richter, Kai ; Kesten, Steven ; O’Donnell, Denis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c416t-57253d43061cc2ce13cf8b66ae565549bba419b6165b664674455c947aeca9a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Aged</topic><topic>bronchodilator agents</topic><topic>Bronchodilator Agents - pharmacology</topic><topic>Bronchodilator Agents - therapeutic use</topic><topic>COPD</topic><topic>Double-Blind Method</topic><topic>dyspnea</topic><topic>Exercise Test</topic><topic>exercise tolerance</topic><topic>Exercise Tolerance - drug effects</topic><topic>Female</topic><topic>Humans</topic><topic>inspiratory capacity</topic><topic>Male</topic><topic>Pulmonary Disease, Chronic Obstructive - drug therapy</topic><topic>Respiratory Function Tests</topic><topic>Scopolamine Derivatives - pharmacology</topic><topic>Scopolamine Derivatives - therapeutic use</topic><topic>Time Factors</topic><topic>tiotropium</topic><topic>Tiotropium Bromide</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maltais, François</creatorcontrib><creatorcontrib>Hamilton, Alan</creatorcontrib><creatorcontrib>Marciniuk, Darcy</creatorcontrib><creatorcontrib>Hernandez, Paul</creatorcontrib><creatorcontrib>Sciurba, Frank C.</creatorcontrib><creatorcontrib>Richter, Kai</creatorcontrib><creatorcontrib>Kesten, Steven</creatorcontrib><creatorcontrib>O’Donnell, Denis</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Chest</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maltais, François</au><au>Hamilton, Alan</au><au>Marciniuk, Darcy</au><au>Hernandez, Paul</au><au>Sciurba, Frank C.</au><au>Richter, Kai</au><au>Kesten, Steven</au><au>O’Donnell, Denis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Improvements in Symptom-Limited Exercise Performance Over 8 h With Once-Daily Tiotropium in Patients With COPD</atitle><jtitle>Chest</jtitle><addtitle>Chest</addtitle><date>2005-09-01</date><risdate>2005</risdate><volume>128</volume><issue>3</issue><spage>1168</spage><epage>1178</epage><pages>1168-1178</pages><issn>0012-3692</issn><eissn>1931-3543</eissn><coden>CHETBF</coden><abstract>We have previously shown that tiotropium at 18 μg reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD. The present study was designed to gain further insight into the duration of improvements.
A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 261 COPD patients (mean age, 62.5 ± 7.4 years [± SD]; 189 men and 72 women; mean FEV1, 1.2 ± 0.4 L [43 ± 12.7% predicted]). On day 0 (first dose), day 21, and day 42 of treatment, pulmonary function tests were performed before and 1 h 20 min after dosing, followed by a constant work rate cycle ergometry test (75% maximum work capacity) to symptom limitation at 2.25 h after dosing. On day 42, an additional constant work rate cycle ergometry test was performed at 8 h after dosing.
Adjusted mean (± SE) endurance time (ET) on day 42 was 803 ± 40 s (tiotropium), vs 568 ± 42 s (placebo) at 2.25 h after dosing (primary end point; treatment difference, 236 ± 58 s; p = 0.0001) and 665 ± 40 s (tiotropium) vs 494 ± 42 s (placebo) at 8 h after dosing (treatment difference, 171 ± 58 s; p = 0.0035). Adjusted mean dyspnea intensity at isotime on day 42 was 4.60 ± 0.16 Borg units (tiotropium), vs 5.65 ± 0.16 Borg units (placebo) at 2.25 h after dosing (p < 0.001), and 5.54 ± 0.17 Borg units (tiotropium) vs 6.51 ± 0.18 Borg units (placebo) at 8 h after dosing (p < 0.001). Adjusted mean pre-exercise inspiratory capacity (IC) on day 42 was 2.41 ± 0.03 L (tiotropium) vs 2.19 ± 0.03 L (placebo) at 2.25 h after dosing (p < 0.001), and 2.31 ± 0.03 L (tiotropium) vs 2.16 ± 0.03 L (placebo) at 8 h after dosing (p < 0.001). The significant increase in IC with tiotropium compared with placebo was maintained throughout exercise.
The present study confirms that tiotropium reduces lung hyperinflation at rest and during exercise, reduces exertional dyspnea, and improves symptom-limited exercise tolerance in COPD patients. Furthermore, this study shows that this improvement is present at 2.25 h and at 8 h after dosing after 6 weeks of treatment.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>16162703</pmid><doi>10.1378/chest.128.3.1168</doi><tpages>11</tpages></addata></record> |
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| ispartof | Chest, 2005-09, Vol.128 (3), p.1168-1178 |
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| subjects | Aged bronchodilator agents Bronchodilator Agents - pharmacology Bronchodilator Agents - therapeutic use COPD Double-Blind Method dyspnea Exercise Test exercise tolerance Exercise Tolerance - drug effects Female Humans inspiratory capacity Male Pulmonary Disease, Chronic Obstructive - drug therapy Respiratory Function Tests Scopolamine Derivatives - pharmacology Scopolamine Derivatives - therapeutic use Time Factors tiotropium Tiotropium Bromide Treatment Outcome |
| title | Improvements in Symptom-Limited Exercise Performance Over 8 h With Once-Daily Tiotropium in Patients With COPD |
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