Safety and Tolerability of COMBIVENT® HFA as Compared to COMBIVENT® CFC and Placebo HFA in Healthy Male and Female Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: COMBIVENT® HFA-MDI

Drug: COMBIVENT® CFC-MDI

Drug: Placebo HFA-MDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT02173678

1012.24

Details and patient eligibility

About

Study to assess the safety and tolerability of COMBIVENT® hydrofluoroalkane (HFA) as compared to COMBIVENT® chlorofluorocarbons (CFC) and placebo HFA after single and repetitive dosing in healthy male and female subjects

Enrollment

12 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males/females
Age range from 21 to 50 years and be within 20% of their normal weight (Broca-Index)
All female volunteers must use a safe contraception (i.e. oral contraceptives, intrauterine devices; sterilised) and must have a negative urine pregnancy test
All subjects must have a negative hepatitis B, C and HIV tests as well as a negative drug screening
Prior to admission to the treatment after giving his/her informed consent (in accordance with Good Clinical Practice and local legislation) in writing, each subject will have his/her medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as 12-lead ECG within 14 days before the first administration of the test drug. Haematopoietic, hepatic and renal function tests will be carried out in the laboratory. The subject will fast for 12 hours before collection of specimens for all laboratory parameters
Currently non-smoking (smoke free for >= one year and <=5 pack year smoking history)
Normal spirometry as evidenced by a baseline FEV1 >= 90% of predicted normal value for age, height and sex
Predicted normal values will be calculated according to European Community for Steel and Coal (ECCS)
Ability to adequately use an inhalation aerosol device
Ability to perform technically satisfactory pulmonary function tests

Exclusion criteria

Volunteers will be excluded from the study if the results of the medical examination or laboratory test (especially serum glutamate oxaloacetate transaminase (SGOT) > 2-fold of upper normal range, serum glutamate pyruvate transaminase (SGPT) > 1.5 - fold of upper normal range) are judged by the investigator to differ significantly from normal clinical values
Volunteers who have an eosinophil count >= 600/mm³. A repeat eosinophil count will not be conducted in these subjects
Volunteers with a serum potassium value >+- 10% outside the normal range
Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic immunological or hormonal disorders
Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
Volunteers with chronic or relevant acute infections
Volunteers with upper respiratory tract infection in the past six weeks prior to the screening visit or between the screening visit and first test day
Volunteers with a history of asthma or allergic rhinitis
Volunteers with history of allergy/hypersensitivity (including drug allergy, especially anticholinergics and beta-agonist agents) which is deemed relevant to the trial as judged by the investigator
Volunteers with known narrow-angle glaucoma
Volunteers with disturbed micturition
Volunteers who have taken a drug with a long half-life (>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
Volunteers who received any concomitant therapy, including over the counter medications (including vitamins, supplements and/or nonsteroidal antiinflammatory drugs; excluding oral or depository contraceptives) within one week of the screening visit
Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
Volunteers who drink more than 40g of alcohol per day
Volunteers who are dependent on drugs
Volunteers who have donated blood (>= 100 ml ) within the last four weeks
Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. contraceptives, intrauterine devices, sterilised)
Volunteers with significant tremor measured on screening visit
Previous participation in this study