Dynamic Hyperinflation and Tiotropium
10. august 2019 oppdatert av: Gelb, Arthur F., M.D.
Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD
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.
Studieoversikt
Detaljert beskrivelse
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
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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Toronto, Ontario, Canada
- Noe Zamel MD
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California
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Lakewood, California, Forente stater, 90712
- Arthur F Gelb MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC < 70%.
- Smoking history > 10 pack yr.
- Clinically stable X 6 weeks.
- No oxygen usage.
Exclusion Criteria:
- History of asthma
- Clinically unstable
- Any other significant medical problem precluding full cooperation for study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Tiotropium 18 µg capsule, bronchodilator
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
|
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
|
|
Placebo komparator: 2
placebo 18ug tiotropium for 1 month
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-
Tidsramme: 30 days
|
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)
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
|
30 days
|
|
Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: 30 days
|
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
Tidsramme: baseline and 30 days (+2h) post dose
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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
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baseline and 30 days (+2h) post dose
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TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo
Tidsramme: one hour before intervention & 2 hrs. after after 30 days
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium
Tidsramme: baseline to 30 days
|
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
|
|
IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema
Tidsramme: baseline to 30 days
|
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
Tidsramme: baseline to trough 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Noe Zamel, MD, Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2006
Primær fullføring (Faktiske)
1. februar 2009
Studiet fullført (Faktiske)
1. mars 2009
Datoer for studieregistrering
Først innsendt
6. desember 2007
Først innsendt som oppfylte QC-kriteriene
6. desember 2007
Først lagt ut (Anslag)
7. desember 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2019
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 20061693
- IIS Boehringer-Ingelheim (Annet stipend/finansieringsnummer: Boehringer-Ingelheim and Pfizer)
- IIS Pfizer (Annet stipend/finansieringsnummer: Pfizer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Please see published data
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