Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
27 november 2013 uppdaterad av: Boehringer Ingelheim
A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
126
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna
- 205.440.1006 Boehringer Ingelheim Investigational Site
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Jasper, Alabama, Förenta staterna
- 205.440.1015 Boehringer Ingelheim Investigational Site
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California
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Torrance, California, Förenta staterna
- 205.440.1002 Boehringer Ingelheim Investigational Site
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Connecticut
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Hartford, Connecticut, Förenta staterna
- 205.440.1018 Boehringer Ingelheim Investigational Site
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Illinois
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Springfield, Illinois, Förenta staterna
- 205.440.1008 Boehringer Ingelheim Investigational Site
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Indiana
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Muncie, Indiana, Förenta staterna
- 205.440.1017 Boehringer Ingelheim Investigational Site
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Michigan
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Livonia, Michigan, Förenta staterna
- 205.440.1020 Boehringer Ingelheim Investigational Site
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna
- 205.440.1011 Boehringer Ingelheim Investigational Site
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North Carolina
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Charlotte, North Carolina, Förenta staterna
- 205.440.1019 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna
- 205.440.1013 Boehringer Ingelheim Investigational Site
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South Carolina
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Spartanburg, South Carolina, Förenta staterna
- 205.440.1007 Boehringer Ingelheim Investigational Site
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Ontario
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Kingston, Ontario, Kanada
- 205.440.2003 Boehringer Ingelheim Investigational Site
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Quebec
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Montreal, Quebec, Kanada
- 205.440.2001 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Kanada
- 205.440.2004 Boehringer Ingelheim Investigational Site
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Ste-Foy, Quebec, Kanada
- 205.440.2002 Boehringer Ingelheim Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 18 mcg tiotropium
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
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double blind randomized crossover
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Placebo-jämförare: Placebo
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
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inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
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Inget ingripande: Control
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline in Inspiratory Capacity (IC) at Isotime
Tidsram: baseline, six weeks of treatment
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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.
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baseline, six weeks of treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Constant Work Rate (CWR) Endurance Time
Tidsram: six weeks of treatment
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CWR exercise duration calculated as the length of time of the exercise period
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six weeks of treatment
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Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Tidsram: baseline, six weeks of treatment
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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).
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baseline, six weeks of treatment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2010
Primärt slutförande (Faktisk)
1 november 2011
Avslutad studie (Faktisk)
1 november 2011
Studieregistreringsdatum
Först inskickad
19 februari 2010
Först inskickad som uppfyllde QC-kriterierna
19 februari 2010
Första postat (Uppskatta)
22 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 december 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 november 2013
Senast verifierad
1 april 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Lungsjukdom, kronisk obstruktiv
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Parasympatholytika
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Kolinerga antagonister
- Kolinerga medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Tiotropiumbromid
Andra studie-ID-nummer
- 205.440
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