Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)

August 29, 2018 updated by: Boehringer Ingelheim

The Effects of Tiotropium Therapy on Airway Diameter in Patients With COPD (a Randomized, Double-blind, Placebo-controlled, Parallel-group Study)

Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients must have a diagnosis of chronic obstructive pulmonary disease
  • Male or female patients ≥ 40 years of age but ≤ 75 years old
  • Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year
  • Patients must be able to perform all specified procedures and maintain records during the study period as required in the protocol
  • Patients must be able to inhale medication from the HandiHaler®
  • All patients must sign a Patient Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications
  • Patients must be willing to attend an outpatient clinic on a regular basis
  • Patients must be able to walk 164 feet (50 meters) during the Six Minute Walk Test

Exclusion Criteria:

  • Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
  • Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis test results, if the abnormality defines a disease listed as an exclusion criterion
  • Patients with a serum glutamic-oxaloacetic transaminase (SGOT) ≥1.5 x Upper Limit of Normal Range (ULN), serum glutamic-pyruvic transaminase (SGPT) ≥1.5 x ULN, bilirubin ≥1.5 x ULN or creatinine ≥ 1.5 x ULN regardless of the clinical condition
  • Patients with a recent history (i.e., one year or less) of myocardial infarction
  • Patients with a recent history (i.e., three years or less) of heart failure, pulmonary edema or patients with any cardiac arrhythmia (with or without symptoms)
  • Patients with regular use of daytime oxygen therapy
  • Patients with known active tuberculosis
  • Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
  • Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
  • Patients who have undergone thoracotomy with pulmonary resection. Patients with a history or a thoracotomy for other reason should be evaluated as per exclusion criterion no. 1
  • Patients with upper respiratory tract infection in the past six weeks prior to the Screening Visit or during the baseline period
  • Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
  • Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
  • Patients with known narrow-angle glaucoma
  • Patients who are being treated with cromolyn sodium or nedocromil sodium
  • Patients who are being treated with antihistamines (H1 receptor antagonists) or antileukotrienes and are not able to stop these medications 1 month before visit 1
  • Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
  • Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3
  • Patients with history of (past five years or less) and/or active alcohol or drug abuse
  • Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Period (Visit 1)
  • Patients who have participated in any pulmonary rehabilitation program for COPD within 6 weeks prior to Visit 1 or throughout the study
  • Limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea such as arthritis in the leg, angina or claudication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tiotropium
Tiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days
Drug: Tiotropium inhalation powder capsules
Placebo Comparator: Placebo
Placebo inhalation powder capsules, one capsule once daily for 28 days
Drug: Placebo inhalation powder capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)
Time Frame: Day 28
Day 28
Trough resting IC
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
FEV1 (Forced expiratory volume in one second)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
FVC (forced vital capacity)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
FEF50% (Forced Expiratory Flow, at 50% of FVC)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
FEF75% (Forced Expiratory Flow, at 75% of FVC)
Time Frame: Day 1, 14, 28
Day 1, 14, 28
SVC (Slow vital capacity)
Time Frame: Day 1, 14, 28
Day 1, 14, 28
Respiratory System Transfer Impedance (Respiratory Resistance)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
Airway Resistance (Raw)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
Thoracic Gas Volume (TGV)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
Specific Airway Conductance (SGaw)
Time Frame: Day 1, 14 and 28
Day 1, 14 and 28
Physician's Global Evaluation
Time Frame: Day 1 and 28
Day 1 and 28
Oxygen Saturation (SaO2) prior to six minute walk test
Time Frame: Day 1 and 28
Day 1 and 28
Oxygen Saturation (SaO2) post six minute walk test
Time Frame: Day 1 and 28
Day 1 and 28
IC prior to six minute walk test
Time Frame: Day 1 and 28
Day 1 and 28
IC post six minute walk test
Time Frame: Day 1 and 28
Day 1 and 28
Chronic Respiratory Questionnaire (CRQ)
Time Frame: Day 1 and 28
Day 1 and 28
Baseline Dyspnea Index (BDI)
Time Frame: Day 1
Day 1
Transition Dyspnea Index (TDI)
Time Frame: Day 28
Day 28
Change from baseline in seated blood pressure
Time Frame: Baseline, Day 1, 14 and 28
Baseline, Day 1, 14 and 28
Change from baseline in pulse rate
Time Frame: Baseline, Day 1, 14 and 28
Baseline, Day 1, 14 and 28
Occurrence of Adverse Events
Time Frame: until day 35
until day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205.218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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