Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274040
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD).

The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Drug: Ipratropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of 18 μg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 μg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response: change from baseline FEV1 (visit 2) to visit 4 trough FEV1 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Trough FVC response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • FVC (AUC0-3) response (as defined for FEV1) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Daily PEFR [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Amount of rescue medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Vital signs (pulse rate and blood pressure) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with abnormalities in routine blood chemistry, haematology and urinanalysis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in 12-lead electrocardiogram (ECG) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 141
Study Start Date: July 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Detailed Description:

This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with COPD.

Each dose of tiotropium or placebo will consist of one capsule self administered from the HandiHaler device once daily during the treatment period (tiotropium or placebo). Each dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.

Each dose of ipratropium MDI or placebo MDI will consist of 2 puffs; patients will inhale 2 puffs four times daily. The first dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.; subsequent doses will be taken at lunch, at dinner and when going to bed.

Study Hypothesis:

The null hypothesis is that there is no difference in mean response between tiotropium and ipratropium.

The alternative hypothesis is that there is a difference in mean response between tiotropium and ipratropium.

Comparison(s):

This is a multi-center, randomized, double-blind, double-dummy, parallel group trial to compare the bronchodilator efficacy and safety of Tiotropium (18 mcg once a day) and ipratropium Metered Dose Inhaler (2 puffs of 18 mcg four times a day).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. All patients must have a diagnosis of chronic obstructive pulmonary disease according to the following criteria:

    Patients must have relatively stable airway obstruction with an FEV1 >= 65% of predicted normal and FEV1 70% of FVC. "Predicted normal values will be based on formulas as supplied by the individual study sites."

  2. Male or female patients 40 years of age or older.
  3. Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
  4. Patients must be able to perform pulmonary function tests as required in the protocol.
  5. Patients must be able to inhale medication from the HandiHaler device and should have a good technique of inhaling aerosol administered from an MDI.
  6. All patients must sign an Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications

Exclusion Criteria

  1. 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.
  2. Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
  3. All patients with a SGOT and SGPT twice the normal range, bilirubin 150% or creatinine 125% of the normal range will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
  4. Patients with a recent history (i.e. one year or less) of myocardial infarction.
  5. Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
  6. Patients with regular use of daytime oxygen therapy.
  7. Patients with known active tuberculosis.
  8. Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
  9. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
  10. Patients who have undergone pulmonary resection or a thoracotomy for any reason.
  11. Patients with an upper respiratory tract infection in the past 6 weeks prior to the Screening Visit (=Visit 1) or during the baseline period of 2-weeks (run-in period).
  12. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system or the MDI
  13. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
  14. Patients with known narrow-angle glaucoma.
  15. Patients who are being treated with cromolyn sodium or nedocromil sodium.
  16. Patients who are being treated with antihistamines.
  17. Patients using oral corticosteroid medication at unstable (i.e. less than 6 weeks on a stable dose) or at a dose in excess of the equivalent 10 mg of prednisone per day or 20 mg every other day.
  18. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm).
  19. Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count 400>= per mcl (males) or 320>= per mcl (females). A repeat eosinophil count will not be conducted in these patients.
  20. Patients with a history and/or active alcohol or drug abuse.
  21. Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the Screening Visit (=Visit 1).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274040

Locations
Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Jeonbuk National University Hospital
Jeonju, Korea, Republic of
Jeonnam National University Hospital
Kwangju, Korea, Republic of
Pusan University Hospital
Pusan, Korea, Republic of
Hanyang University Hosital
Seoul, Korea, Republic of
Shinchon Severence Hosp (Yonsei University Hosp)
Seoul, Korea, Republic of
National Medical Center
Seoul, Korea, Republic of
Seoul Asan Hospital
Seoul, Korea, Republic of
Samsung Seoul Hospital
Seoul, Korea, Republic of
Kyunghee University Hospital
Seoul, Korea, Republic of
Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Kyoungbuk National University Hospital
Seoul, Korea, Republic of
Korea University Hospital
Seoul, Korea, Republic of
St. Paul's Hospital, Dept. of Respiratory
Seoul, Korea, Republic of
Youngdong Sevarence Hospital (Yonsei University Hospital)
Seoul, Korea, Republic of
Chung-ang University Hospital
Seoul, Korea, Republic of
Wonju Christian Hospital (Yonsei University Hosp)
Wonju, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Korea Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274040     History of Changes
Other Study ID Numbers: 205.244
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: Korea: Korea Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Ipratropium
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics

ClinicalTrials.gov processed this record on August 26, 2014