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HealthyPhase 1NCT02173678

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

A Phase 1 study testing COMBIVENT® HFA-MDI and COMBIVENT® CFC-MDI in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
COMBIVENT® HFA-MDI and COMBIVENT® CFC-MDI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
No sites listed yet
Study dates
Oct 1999to Nov 1999
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

About this study

Official title: 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

Conditions
Healthy
Being tested
COMBIVENT® HFA-MDI, COMBIVENT® CFC-MDI, Placebo HFA-MDI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMBIVENT® HFA-MDIDrug

  • COMBIVENT® CFC-MDIDrug

  • Placebo HFA-MDIDrug

Study groups in NCT02173678
Study groupRoleWhat they receive
COMBIVENT® HFAExperimentalNot described
Receives: Drug: COMBIVENT® HFA-MDI
COMBIVENT® CFCActive comparatorNot described
Receives: Drug: COMBIVENT® CFC-MDI
Placebo HFA-MDI (metered dose inhaler)Placebo comparatorNot described
Receives: Drug: Placebo HFA-MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Potential bronchoconstriction, objectively assessed by FEV1 and the occurence of cough, wheeze and shortness of breath

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  2. Forced expiratory volume in one second (FEV1)

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  3. Peak expiratory flow (PEF)

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  4. Forced Vital Capacity (FVC)

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  5. Mean maximal expiratory flow over the middle 50% of the FVC (MMEF25/75)

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  6. Changes in serum potassium levels

    Measured: Baseline, 85, 120, 155, 170 , 200, 230, 260 min after first inhalation

  7. Occurence of adverse events

    Measured: up to 30 days

  8. Changes in blood pressure

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  9. Changes in pulse rate

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  10. Changes in respiratory rate

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  11. Tremor measurement

    Measured: Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation

  12. Changes in electrocardiogram (ECG), QTc interval

    Measured: Baseline, 85, 120, 155, 170, 200 min after first inhalation (230, 260, 320 min only to be performed if abnormal ECG)

  13. Number of subjects with clinically relevant changes from baseline in physical examination

    Measured: Screening, end-of study-evaluation (within 8 days after the last treatment)

  14. Number of subjects with clinically signification changes from baseline in laboratory values

    Measured: Screening, end-of study-evaluation (within 8 days after the last treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2014 (estimated)
  2. Study startOct 1999
  3. Primary completionNov 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173678
Sponsor's protocol ID
1012.24
Status last verified
Jun 2014
First submitted
24 Jun 2014
Last updated
4 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing COMBIVENT® HFA-MDI and COMBIVENT® CFC-MDI in people with Healthy, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02173678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2014.

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Clinical Trial NCT02173678 | AzTrials