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

July 3, 2014 updated by: Boehringer Ingelheim

A Randomized, Placebo-controlled, Double-blind, 3 Way Cross-over Safety and Tolerability Study of Single and Repetitive Dosing of COMBIVENT® HFA Compared to COMBIVENT® CFC and Placebo HFA in Healthy Male and Female Subjects (Cumulative Dose: 1600 mcg (HFA) or 1648 mcg (CFC) of Salbutamol Sulfate, 288 mcg of Ipratropium Bromide)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COMBIVENT® HFA
Drug: COMBIVENT® HFA-MDI
Active Comparator: COMBIVENT® CFC
Drug: COMBIVENT® CFC-MDI
Placebo Comparator: Placebo HFA-MDI (metered dose inhaler)
Drug: Placebo HFA-MDI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Potential bronchoconstriction, objectively assessed by FEV1 and the occurence of cough, wheeze and shortness of breath
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Forced expiratory volume in one second (FEV1)
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Peak expiratory flow (PEF)
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Forced Vital Capacity (FVC)
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Mean maximal expiratory flow over the middle 50% of the FVC (MMEF25/75)
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in serum potassium levels
Time Frame: Baseline, 85, 120, 155, 170 , 200, 230, 260 min after first inhalation
Baseline, 85, 120, 155, 170 , 200, 230, 260 min after first inhalation
Occurence of adverse events
Time Frame: up to 30 days
up to 30 days
Changes in blood pressure
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in pulse rate
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in respiratory rate
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Tremor measurement
Time Frame: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation
Changes in electrocardiogram (ECG), QTc interval
Time Frame: Baseline, 85, 120, 155, 170, 200 min after first inhalation (230, 260, 320 min only to be performed if abnormal ECG)
Baseline, 85, 120, 155, 170, 200 min after first inhalation (230, 260, 320 min only to be performed if abnormal ECG)
Number of subjects with clinically relevant changes from baseline in physical examination
Time Frame: Screening, end-of study-evaluation (within 8 days after the last treatment)
Screening, end-of study-evaluation (within 8 days after the last treatment)
Number of subjects with clinically signification changes from baseline in laboratory values
Time Frame: Screening, end-of study-evaluation (within 8 days after the last treatment)
Screening, end-of study-evaluation (within 8 days after the last treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1012.24

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