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

NCT ID: NCT00523991

Last Updated: 2014-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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placebo

Oral inhalation once daily of placebo matching tiotropium via handihaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral inhalation once daily of placebo matching tiotropium via handihaler

tiotropium

Oral inhalation once daily of 18mcg tiotropium via handihaler

Group Type EXPERIMENTAL

tiotropium

Intervention Type DRUG

Oral inhalation once daily of 18mcg tiotropium via handihaler

Interventions

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tiotropium

Oral inhalation once daily of 18mcg tiotropium via handihaler

Intervention Type DRUG

Placebo

Oral inhalation once daily of placebo matching tiotropium via handihaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.365.1003 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

205.365.1004 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

205.365.1098 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

205.365.1023 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Site Status

205.365.1125 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

205.365.1024 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

205.365.1012 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

205.365.1086 Boehringer Ingelheim Investigational Site

Bloomington, Minnesota, United States

Site Status

205.365.1006 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

Site Status

205.365.1085 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

205.365.1010 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

205.365.1007 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

205.365.1080 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

205.365.1118 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

205.365.1033 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

205.365.1092 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

Site Status

205.365.1122 Boehringer Ingelheim Investigational Site

Clarksburg, West Virginia, United States

Site Status

205.365.1103 Boehringer Ingelheim Investigational Site

Gilly, , Belgium

Site Status

205.365.1059 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

205.365.1057 Boehringer Ingelheim Investigational Site

Menen, , Belgium

Site Status

205.365.1058 Boehringer Ingelheim Investigational Site

Yvoir, , Belgium

Site Status

205.365.1042 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

205.365.1056 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Site Status

205.365.1104 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

205.365.1041 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Site Status

205.365.1064 Boehringer Ingelheim Investigational Site

Cvikov, , Czechia

Site Status

205.365.1107 Boehringer Ingelheim Investigational Site

Hradec Králové, , Czechia

Site Status

205.365.1061 Boehringer Ingelheim Investigational Site

Karlovy Vary, , Czechia

Site Status

205.365.1077 Boehringer Ingelheim Investigational Site

Liberec, , Czechia

Site Status

205.365.1079 Boehringer Ingelheim Investigational Site

Neratovice, , Czechia

Site Status

205.365.1116 Boehringer Ingelheim Investigational Site

Pardubice, , Czechia

Site Status

205.365.1062 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

205.365.1083 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

205.365.1117 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

205.365.1075 Boehringer Ingelheim Investigational Site

Strakonice, , Czechia

Site Status

205.365.1063 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

Site Status

205.365.1076 Boehringer Ingelheim Investigational Site

Ústí nad Labem, , Czechia

Site Status

205.365.1055 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

205.365.1066 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

205.365.1054 Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

Site Status

205.365.1052 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

205.365.1050 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

205.365.1067 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

205.365.1127 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

205.365.1126 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

205.365.1070 Boehringer Ingelheim Investigational Site

Enschede, , Netherlands

Site Status

205.365.1072 Boehringer Ingelheim Investigational Site

Etten-Leur, , Netherlands

Site Status

205.365.1071 Boehringer Ingelheim Investigational Site

Spijkenisse, , Netherlands

Site Status

205.365.1069 Boehringer Ingelheim Investigational Site

Zutphen, , Netherlands

Site Status

205.365.1025 Boehringer Ingelheim Investigational Site

Amadora, , Portugal

Site Status

205.365.1020 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

205.365.1022 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

205.365.1128 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

205.365.1108 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

205.365.1110 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

205.365.1112 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

205.365.1114 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

205.365.1115 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

205.365.1113 Boehringer Ingelheim Investigational Site

Simferopol, , Ukraine

Site Status

205.365.44002 Boehringer Ingelheim Investigational Site

Garston, Watford, , United Kingdom

Site Status

205.365.44003 Boehringer Ingelheim Investigational Site

Harrow, , United Kingdom

Site Status

205.365.44004 Boehringer Ingelheim Investigational Site

Warminster, , United Kingdom

Site Status

Countries

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United States Belgium Canada Czechia Germany Greece Netherlands Portugal Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24841833 (View on PubMed)

Other Identifiers

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A4471008

Identifier Type: OTHER

Identifier Source: secondary_id

2006-006276-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.365

Identifier Type: -

Identifier Source: org_study_id

NCT00460772

Identifier Type: -

Identifier Source: nct_alias

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