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Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT02175342
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in patients with COPD.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium 0.625 mcg/puff Drug: Tiotropium 1.25 mcg/puff Drug: Tiotropium 2.5 mcg/puff Drug: Tiotropium 5 mcg/puff Drug: Placebo solution Drug: Tiotropium-18 lactose powder Drug: Placebo lactose powder Drug: Tiotropium 10 mcg/puff Device: Respimat Device: Handihaler Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized, 3-week Multiple-dose, Placebo Controlled, Intraformulation Double-blind, Parallel Group Study
Study Start Date : March 1998
Actual Primary Completion Date : April 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Tiotropium-1.25 Respimat
Two puffs of tiotropium inhalation solution from a Respimat device, 0.625 mcg/puff
Drug: Tiotropium 0.625 mcg/puff
Device: Respimat
Experimental: Tiotropium-2.5 Respimat
Two puffs of tiotropium inhalation solution from a Respimat device, 1.25 mcg/puff
Drug: Tiotropium 1.25 mcg/puff
Device: Respimat
Experimental: Tiotropium-5 Respimat
Two puffs of tiotropium inhalation solution from a Respimat device, 2.5 mcg/puff
Drug: Tiotropium 2.5 mcg/puff
Device: Respimat
Experimental: Tiotropium-10 Respimat
Two puffs of tiotropium inhalation solution from a Respimat device, 5 mcg/puff
Drug: Tiotropium 5 mcg/puff
Device: Respimat
Experimental: Tiotropium-20 Respimat
Two puffs of tiotropium inhalation solution from a Respimat device, 10 mcg/puff
Drug: Tiotropium 10 mcg/puff
Device: Respimat
Placebo Comparator: Placebo Respimat Drug: Placebo solution
Device: Respimat
Active Comparator: Tiotropium-18 lactose powder Handihaler Drug: Tiotropium-18 lactose powder
Device: Handihaler
Placebo Comparator: Placebo lactose powder Handihaler Drug: Placebo lactose powder
Device: Handihaler



Primary Outcome Measures :
  1. Forced expiratory volume in one second (FEV1) with emphasis on the last two hours of the 24-hour dosing interval (trough FEV1) [ Time Frame: last two hours of the 24-hour dosing interval ]

Secondary Outcome Measures :
  1. Forced expiratory volume in one second (FEV1) [ Time Frame: during the first four hours post dose ]
  2. Forced Vital Capacity (FVC) [ Time Frame: during first four hours post dose ]
  3. Pharmacokinetic evaluation: 2-hours urine sampling pre- and post-dose (10 patients per group) [ Time Frame: before and after last drug administration at day7,14 and 21. ]
  4. Chronic obstructive pulmonary disease symptom scores, physician's global evaluation, sleep question and use of rescue medication [ Time Frame: 3 weeks treatment period ]
  5. Changes in ECG, pulse rate (PR) and blood pressure (BP) from the pre-dose values recorded on test day [ Time Frame: Day 0, day 7, day 14, day 21 ]
  6. Changes in ECG, physical examination, haematology and biochemistry recorded before and after the trial [ Time Frame: Screening, 24 to 28 days after treatment ]
  7. Occurrence of adverse events [ Time Frame: up to 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 40 years;
  2. Diagnosis of COPD and met the following criteria:

    1. Relatively stable, moderate to severe airway obstruction,
    2. Baseline 30% ≤ FEV1 ≤ 65% of predicted normal value, predicted normal values are based on the guidelines for standardized lung function testing of the European Community for Coal and Steel (ECCS) ,
    3. Baseline FEV1/ forced expiratory vital capacity (FEVC) ≤ 70%;
  3. Smoking history ≥ 10 pack-years (p.y.). A p.y. is defined as the equivalent of smoking one pack of cigarettes per day for one year;
  4. Male of female;
  5. Ability to be trained in the proper use of Respimat and Handihaler;
  6. Ability to be trained in the performance of technically satisfactory pulmonary function tests;
  7. Ability to provide written informed consent
  8. Patient affiliated to the Social Security System

Exclusion Criteria:

  1. History of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm³
  2. Changes in the therapeutic (pulmonary) plan within the last six weeks prior to the Screening Visit;
  3. Treatment by cromolyn/nedocromil sodium;
  4. Treatment by antihistamines (H1 receptor antagonists);
  5. A lower respiratory tract infection or any exacerbation in the past six weeks prior to the Screening Visit;
  6. Regular use of daytime oxygen therapy;
  7. Treatment by oral corticosteroid medication if initiated or modified within the last six weeks or if daily dose > 10 mg prednisone equivalent;
  8. History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
  9. Patients who have undergone thoracotomy with pulmonary resection;
  10. History of clinically significant cardiovascular, renal neurologic, liver or endocrine dysfunction. A clinically significant disease was defined as one 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.
  11. Patients with a recent (≤ one year) history of myocardial infarction, of heart failure or patients with any cardiac arrhythmia requiring drug therapy;
  12. Tuberculosis with indication for treatment;
  13. History of cancer within the last five years. Patients with treated basal cell carcinoma were allowed:
  14. Current psychiatric disorders;
  15. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction;
  16. Patients with any history of glaucoma or increased intra-ocular pressure;
  17. Patients with clinically significant abnormal baseline haematology or blood chemistry, if the abnormality defines a disease listed as an exclusion criterion;
  18. Patients with

    1. glutamyl-oxalo-acetic transaminase/glutamyl-pyruvic transaminase (SGOT/SGPT): > 200% of the upper limit of the normal range (ULN, )
    2. bilirubin: > 150% of the ULN,
    3. creatinine: > 125% of the ULN;
  19. Intolerance to aerosolised anticholinergic containing products, and/or hypersensitivity to benzalkonium chloride, to lactose or any other components of the inhalation capsule delivery system;
  20. Beta-blocker medication;
  21. Concomitant or recent (within the last month) use of investigational drugs;
  22. History of drug abuse and/or alcoholism;
  23. Pregnant or nursing women and women of childbearing potential not using a medically approved means of contraception ( urinary pregnancy test at screening);
  24. Previous participation in this study (i.e. having been allocated a randomised treatment number);
  25. Patients deprived of their freedom by a judicial or administrative decision;
  26. Minors, adults under guardianship;
  27. Persons in medical or social establishments;
  28. Patients in emergency situations
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02175342    
Other Study ID Numbers: 205.127
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action