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

NCT00523991

Last updated date
Study Location
205.365.1003 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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NCT00523991
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Jasper, Alabama
  4. Palo Alto, California
  5. San Diego, California
  6. Lexington, Kentucky
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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Official Title  ICMJE A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: tiotropium
    Oral inhalation once daily of 18mcg tiotropium via handihaler
  • Drug: Placebo
    Oral inhalation once daily of placebo matching tiotropium via handihaler
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Oral inhalation once daily of placebo matching tiotropium via handihaler
    Intervention: Drug: Placebo
  • Experimental: tiotropium
    Oral inhalation once daily of 18mcg tiotropium via handihaler
    Intervention: Drug: tiotropium
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2010)
457
Original Enrollment  ICMJE
 (submitted: August 31, 2007)
436
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czech Republic,   Germany,   Greece,   Netherlands,   Portugal,   Ukraine,   United Kingdom,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT00523991
Other Study ID Numbers  ICMJE 205.365
A4471008 ( Other Identifier: OTHER )
2006-006276-38 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP