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

NCT ID: NCT02172781

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ipratropium - unit dose vial

Group Type: EXPERIMENTAL

Ipratropium - unit dose vial

Intervention Type: DRUG

Placebo matching ipratropium

Intervention Type: DRUG

Tiotropium - inhalation capsule - low dose

Group Type: EXPERIMENTAL

Ipratropium - unit dose vial

Intervention Type: DRUG

Tiotropium - inhalation capsule

Intervention Type: DRUG

Placebo matching tiotropium

Intervention Type: DRUG

Placebo matching ipratropium

Intervention Type: DRUG

Placebo matching tiotropium - inhalation capsule

Group Type: PLACEBO_COMPARATOR

Ipratropium - unit dose vial

Intervention Type: DRUG

Tiotropium - inhalation capsule

Intervention Type: DRUG

Placebo matching tiotropium

Intervention Type: DRUG

Placebo matching ipratropium

Intervention Type: DRUG

Placebo matching to ipratropium - unit dose vial

Group Type: PLACEBO_COMPARATOR

Ipratropium - unit dose vial

Intervention Type: DRUG

Tiotropium - inhalation capsule

Intervention Type: DRUG

Placebo matching tiotropium

Intervention Type: DRUG

Placebo matching ipratropium

Intervention Type: DRUG

Tiotropium - inhalation capsule - high dose

Group Type: EXPERIMENTAL

Ipratropium - unit dose vial

Intervention Type: DRUG

Tiotropium - inhalation capsule

Intervention Type: DRUG

Placebo matching ipratropium

Intervention Type: DRUG

Interventions

Ipratropium - unit dose vial

Intervention Type: DRUG

Tiotropium - inhalation capsule

Intervention Type: DRUG

Placebo matching tiotropium

Intervention Type: DRUG

Placebo matching ipratropium

Intervention Type: DRUG

Eligibility Criteria

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.

• 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)

• Subjects with known hypersensitivity to anticholinergic drugs.
• Subjects with known symptomatic prostatic hypertrophy or bladder neck obstruction
• Subjects with known narrow-angle glaucoma

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

205.239

Identifier Type: -

Identifier Source: org_study_id