NCT00569270

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 5, 2012

Completed
Last Updated

August 20, 2019

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

December 6, 2007

Results QC Date

August 20, 2011

Last Update Submit

August 10, 2019

Conditions

COPD

Outcome Measures

Primary Outcomes (14)

  • 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

    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

Secondary Outcomes (3)

  • Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After 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

    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

    baseline to trough tiotropium

Study Arms (2)

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

Drug: Placebo

2

PLACEBO COMPARATOR

placebo 18ug tiotropium for 1 month

Drug: Placebo

Interventions

PlaceboDRUG

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

2Tiotropium 18 µg capsule, bronchodilator

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of asthma
  • Clinically unstable
  • Any other significant medical problem precluding full cooperation for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arthur F Gelb MD

Lakewood, California, 90712, United States

Location

Noe Zamel MD

Toronto, Ontario, Canada

Location

Related Publications (3)

  • 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.

    PMID: 15596684BACKGROUND

  • 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.

    PMID: 17356081BACKGROUND

  • 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.

    PMID: 21159499DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Arthur F Gelb MD Principal Investigator
Organization
Arthur F Gelb MD
afgelb@msn.com
562-633-2204

Study Officials

  • Arthur F Gelb, MD

    Arthur F Gelb Medical Corporation

    PRINCIPAL INVESTIGATOR

  • Noe Zamel, MD

    Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

October 1, 2006

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

August 20, 2019

Results First Posted

October 5, 2012

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Please see published data

Locations

US(1)CA(1)