Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment

Boehringer Ingelheim36 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Ipratropium - unit dose vialDRUG

Tiotropium - inhalation capsuleDRUG

Placebo matching tiotropiumDRUG

Placebo matching ipratropiumDRUG

Eligibility

Sex: MALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: All participants in the study should be healthy males, ranging from 40 to 65 years of age and within ±20% of their normal weight (Broca-Index) Each subject will have his medical history taken and will receive a complete medical examination (including blood pressure and pulse rate measurements) as well as a 12-lead ECG. Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscentia GmbH, FRG). The subjects will fast for 8 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first drug administration. In accordance with Good Clinical Practice (GCP) and local legislation all subjects will have given their written informed consent prior to admission to the study. Following inclusion criteria were of special interest for this study: * Normal spirometry as evidenced by a baseline FEV1 ≥ 80% of predicted normal value for age, height and sex. Predicted normal values will be calculated according to European Community of Coal and Steel (ECCS) * Ability to perform technically satisfactory pulmonary function tests. Exclusion Criteria: * Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance. * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders. * History of orthostatic hypotension, fainting spells or blackouts. * Chronic or relevant acute infections. * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator. * Intake of drugs with a long half-life (≥ 24hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study. * Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study, among these all non-selective beta blockers, oral beta adrenergics or long-acting beta-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT ®(ipratropium) by oral inhalation and ATROVENT® Nasal Spray. * Participation in another trial with an investigational drug (≤ two months prior to administration or during trial). * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on trial days. * Alcohol abuse (\> 60g/day) * Drug abuse * Blood donation (≥ 100 ml within four weeks prior to administration or during the trial) * Any laboratory value outside the clinically accepted reference range. * Excessive physical activities (within the last week before and during the study) Following exclusion criteria are of special interest for the study: * Subjects with known hypersensitivity to anticholinergic drugs. * Subjects with known symptomatic prostatic hypertrophy or bladder neck obstruction * Subjects with known narrow-angle glaucoma

Outcomes

Primary Outcomes

AUC - Area under the curve of the log-transformed value of salivary secretion after application of randomised treatment

Time frame: over the interval from two hours to six hours on study day 19 and 22