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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

Tracking Information
First Submitted Date  ICMJE June 24, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date June 26, 2014
Study Start Date  ICMJE March 1998
Actual Primary Completion Date April 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • Forced expiratory volume in one second (FEV1) [ Time Frame: during the first four hours post dose ]
  • Forced Vital Capacity (FVC) [ Time Frame: during first four hours post dose ]
  • 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. ]
  • Chronic obstructive pulmonary disease symptom scores, physician's global evaluation, sleep question and use of rescue medication [ Time Frame: 3 weeks treatment period ]
  • 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 ]
  • Changes in ECG, physical examination, haematology and biochemistry recorded before and after the trial [ Time Frame: Screening, 24 to 28 days after treatment ]
  • Occurrence of adverse events [ Time Frame: up to 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Tiotropium-1.25 Respimat
    Two puffs of tiotropium inhalation solution from a Respimat device, 0.625 mcg/puff
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Drug: Tiotropium 5 mcg/puff
    • Device: Respimat
  • Experimental: Tiotropium-20 Respimat
    Two puffs of tiotropium inhalation solution from a Respimat device, 10 mcg/puff
    Interventions:
    • Drug: Tiotropium 10 mcg/puff
    • Device: Respimat
  • Placebo Comparator: Placebo Respimat
    Interventions:
    • Drug: Placebo solution
    • Device: Respimat
  • Active Comparator: Tiotropium-18 lactose powder Handihaler
    Interventions:
    • Drug: Tiotropium-18 lactose powder
    • Device: Handihaler
  • Placebo Comparator: Placebo lactose powder Handihaler
    Interventions:
    • Drug: Placebo lactose powder
    • Device: Handihaler
Publications * Not Provided

*   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: June 25, 2014)
202
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02175342
Other Study ID Numbers  ICMJE 205.127
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date June 2014

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