Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

NCT00523991 | Completed Phase 4 Results

• 3 other identifiers: 205.365A44710082006-006276-38
• Study Type: interventional
• Target: 457
• Locations: 10 countries
• Sites: 62

Brief Summary

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)

  Change = Week 24 Value - Baseline Value

  baseline, week 24

Secondary Outcomes (136)

• Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)

  Baseline

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)

  Baseline, week 8

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)

  Baseline, week 16

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)

  Baseline, week 24

• Peak Forced Expiratory Volume in 1 Second (Baseline)

  Baseline

Study Arms (2)

placebo

PLACEBO COMPARATOR

Oral inhalation once daily of placebo matching tiotropium via handihaler

Drug: Placebo

tiotropium

EXPERIMENTAL

Oral inhalation once daily of 18mcg tiotropium via handihaler

Drug: tiotropium

Interventions

tiotropium DRUG

Oral inhalation once daily of 18mcg tiotropium via handihaler

tiotropium

Placebo DRUG

Oral inhalation once daily of placebo matching tiotropium via handihaler

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:
• post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio \< 70% (visit 1).
• Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 \>50% and \< 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of \>=10 pack years.
• Subjects must have a Medical Research Council (MRC) dyspnea score \>= 2.

You may not qualify if:

• Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
• Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
• Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Pfizer: collaborator

Study Sites (62)

205.365.1003 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.365.1004 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.365.1098 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

205.365.1023 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Location

205.365.1125 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

205.365.1024 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

205.365.1012 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

205.365.1086 Boehringer Ingelheim Investigational Site

Bloomington, Minnesota, United States

Location

205.365.1006 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

Location

205.365.1085 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

205.365.1010 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

205.365.1007 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

205.365.1080 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

205.365.1118 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.365.1033 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

205.365.1092 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

Location

205.365.1122 Boehringer Ingelheim Investigational Site

Clarksburg, West Virginia, United States

Location

205.365.1103 Boehringer Ingelheim Investigational Site

Gilly, Belgium

Location

205.365.1059 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

205.365.1057 Boehringer Ingelheim Investigational Site

Menen, Belgium

Location

205.365.1058 Boehringer Ingelheim Investigational Site

Yvoir, Belgium

Location

205.365.1042 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

205.365.1056 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Location

205.365.1104 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

205.365.1041 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Location

205.365.1064 Boehringer Ingelheim Investigational Site

Cvikov, Czechia

Location

205.365.1107 Boehringer Ingelheim Investigational Site

Hradec Králové, Czechia

Location

205.365.1061 Boehringer Ingelheim Investigational Site

Karlovy Vary, Czechia

Location

205.365.1077 Boehringer Ingelheim Investigational Site

Liberec, Czechia

Location

205.365.1079 Boehringer Ingelheim Investigational Site

Neratovice, Czechia

Location

205.365.1116 Boehringer Ingelheim Investigational Site

Pardubice, Czechia

Location

205.365.1062 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

205.365.1083 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

205.365.1117 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

205.365.1075 Boehringer Ingelheim Investigational Site

Strakonice, Czechia

Location

205.365.1063 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

205.365.1076 Boehringer Ingelheim Investigational Site

Ústí nad Labem, Czechia

Location

205.365.1055 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.365.1066 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.365.1054 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

205.365.1052 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

205.365.1050 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

205.365.1067 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.365.1127 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.365.1126 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

205.365.1070 Boehringer Ingelheim Investigational Site

Enschede, Netherlands

Location

205.365.1072 Boehringer Ingelheim Investigational Site

Etten-Leur, Netherlands

Location

205.365.1071 Boehringer Ingelheim Investigational Site

Spijkenisse, Netherlands

Location

205.365.1069 Boehringer Ingelheim Investigational Site

Zutphen, Netherlands

Location

205.365.1025 Boehringer Ingelheim Investigational Site

Amadora, Portugal

Location

205.365.1020 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

205.365.1022 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

205.365.1128 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, Ukraine

Location

205.365.1108 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

205.365.1110 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

205.365.1112 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

205.365.1114 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

205.365.1115 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

205.365.1113 Boehringer Ingelheim Investigational Site

Simferopol, Ukraine

Location

205.365.44002 Boehringer Ingelheim Investigational Site

Garston, Watford, United Kingdom

Location

205.365.44003 Boehringer Ingelheim Investigational Site

Harrow, United Kingdom

Location

205.365.44004 Boehringer Ingelheim Investigational Site

Warminster, United Kingdom

Location

Related Publications (1)

• Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3.

  PMID: 24841833 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

For individual outcome measures, only timepoints that had data collected are presented here.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: September 3, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2010
• Last Updated: May 20, 2014
• Results First Posted: December 29, 2011

Record last verified: 2014-05

Locations

GR (3); PT (3); CA (4); UA (7); BE (4); NL (4); CZ (12); DE (5); US (17); GB (3)