Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tiotropium inhalation powder capsules
Placebo inhalation powder capsules
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tiotropium
Placebo
Arm Description
Tiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days
Placebo inhalation powder capsules, one capsule once daily for 28 days
Outcomes
Primary Outcome Measures
Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)
Trough resting IC
Secondary Outcome Measures
FEV1 (Forced expiratory volume in one second)
FVC (forced vital capacity)
FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)
FEF50% (Forced Expiratory Flow, at 50% of FVC)
FEF75% (Forced Expiratory Flow, at 75% of FVC)
SVC (Slow vital capacity)
Respiratory System Transfer Impedance (Respiratory Resistance)
Airway Resistance (Raw)
Thoracic Gas Volume (TGV)
Specific Airway Conductance (SGaw)
Physician's Global Evaluation
Oxygen Saturation (SaO2) prior to six minute walk test
Oxygen Saturation (SaO2) post six minute walk test
IC prior to six minute walk test
IC post six minute walk test
Chronic Respiratory Questionnaire (CRQ)
Baseline Dyspnea Index (BDI)
Transition Dyspnea Index (TDI)
Change from baseline in seated blood pressure
Change from baseline in pulse rate
Occurrence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172391
Brief Title
Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
The Effects of Tiotropium Therapy on Airway Diameter in Patients With COPD (a Randomized, Double-blind, Placebo-controlled, Parallel-group Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
81 (false)
8. Arms, Groups, and Interventions
Arm Title
Tiotropium
Arm Type
Experimental
Arm Description
Tiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inhalation powder capsules, one capsule once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Tiotropium inhalation powder capsules
Intervention Type
Drug
Intervention Name(s)
Placebo inhalation powder capsules
Primary Outcome Measure Information:
Title
Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)
Time Frame
Day 28
Title
Trough resting IC
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
FEV1 (Forced expiratory volume in one second)
Time Frame
Day 1, 14 and 28
Title
FVC (forced vital capacity)
Time Frame
Day 1, 14 and 28
Title
FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)
Time Frame
Day 1, 14 and 28
Title
FEF50% (Forced Expiratory Flow, at 50% of FVC)
Time Frame
Day 1, 14 and 28
Title
FEF75% (Forced Expiratory Flow, at 75% of FVC)
Time Frame
Day 1, 14, 28
Title
SVC (Slow vital capacity)
Time Frame
Day 1, 14, 28
Title
Respiratory System Transfer Impedance (Respiratory Resistance)
Time Frame
Day 1, 14 and 28
Title
Airway Resistance (Raw)
Time Frame
Day 1, 14 and 28
Title
Thoracic Gas Volume (TGV)
Time Frame
Day 1, 14 and 28
Title
Specific Airway Conductance (SGaw)
Time Frame
Day 1, 14 and 28
Title
Physician's Global Evaluation
Time Frame
Day 1 and 28
Title
Oxygen Saturation (SaO2) prior to six minute walk test
Time Frame
Day 1 and 28
Title
Oxygen Saturation (SaO2) post six minute walk test
Time Frame
Day 1 and 28
Title
IC prior to six minute walk test
Time Frame
Day 1 and 28
Title
IC post six minute walk test
Time Frame
Day 1 and 28
Title
Chronic Respiratory Questionnaire (CRQ)
Time Frame
Day 1 and 28
Title
Baseline Dyspnea Index (BDI)
Time Frame
Day 1
Title
Transition Dyspnea Index (TDI)
Time Frame
Day 28
Title
Change from baseline in seated blood pressure
Time Frame
Baseline, Day 1, 14 and 28
Title
Change from baseline in pulse rate
Time Frame
Baseline, Day 1, 14 and 28
Title
Occurrence of Adverse Events
Time Frame
until day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.218_U02-3256.pdf
Description
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Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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