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Pulmonary Disease, Chronic ObstructivePhase 3NCT02177344

Safety and Efficacy of Two Different Doses of Ipratropium Bromide Versus ATROVENT® Inhalation Aerosol in Adults With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Low dose of Ipratropium bromide, High dose of Ipratropium bromide and Atrovent in people with Pulmonary Disease, Chronic Obstructive, 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

The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Low dose of Ipratropium bromide, High dose of Ipratropium bromide and Atrovent
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
646 participants
Where
No sites listed yet
Study dates
Aug 1998to Oct 1999
Phase
Phase 3
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
  • Patients must have relatively stable, moderate to severe airway obstruction with a FEV1 =< 65% of predicted normal and FEV1 =< 70% of FVC
  • Male or female patients 40 years of age or older
  • Patients must have a smoking history of more than ten packs-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
  • Patients must be able to perform pulmonary function tests and maintain records during the study period, as required in the protocol
  • Patients must be able to be trained in the proper use of an inhalation aerosol and the Respimat device
  • All patients must sign an Informed Consent Form prior to participation in the trial i.e., at least 24 hours prior to screening (Visit 1)

Who cannot join

  • Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease, which in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
  • Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
  • All patients with a serum glutamate oxaloacetate transaminase > 80 U/L, serum glutamate pyruvate transaminase > 80 U/L, bilirubin > 34.2 µmol/L or creatinine > 176.8 µmol/L will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
  • Patients who have a blood eosinophil count >= 0.6 GI/L. A repeat eosinophil count will not be conducted in these patients
  • Patients with a recent history (i.e., one year or less) of myocardial infarction
  • Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
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  • Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years
  • Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
  • Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion #1
  • Patients with a history of asthma, allergic rhinitis or atopy
  • Patients with a history of and/or active alcohol or drug abuse
  • Patients with known active tuberculosis
  • Patients with an upper respiratory tract infection or COPD exacerbation in the past six weeks prior to the Screening Visit (Visit 1) or during the baseline period
  • Patients with known symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
  • Patients with known narrow-angle glaucoma, or raised intra-ocular pressure
  • Patients with current significant psychiatric disorders
  • Patients with regular use of daytime oxygen therapy
  • Patients who are being treated with cromolyn sodium or nedocromil sodium
  • Patients who are being treated with antihistamines
  • Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
  • Patients who are being treated with beta-blocker medication
  • Patients who have had changes in their therapeutic plan within the last six weeks prior to the Screening Visit (Visit 1)
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®)
  • Patients with known hypersensitivity to anticholinergic drugs or any other components of the ATROVENT® Solution including Benzalkonium chloride and Edetic acid
  • Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
  • Previous participation in this study

About this study

Official title: A Six Month, Randomized, Double-blind (Within Formulation), Multiple Dose Trial to Compare the Safety and Efficacy of 20 mcg and 40 mcg of Ipratropium Bromide, as Delivered by the RESPIMAT Device, to 18 mcg ATROVENT® Inhalation Aerosol (x 2 Puffs) and Respective Placebos in Adults, With Chronic Obstructive Pulmonary Disease

The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary disease (COPD). The efficacy and safety profiles of the two doses administered via the RESPIMAT device will also be compared to their respective placebo groups

Being tested
Low dose of Ipratropium bromide, High dose of Ipratropium bromide, Atrovent, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Low dose of Ipratropium bromideDrug

    One puff, 4 times daily by oral inhalation

  • High dose of Ipratropium bromideDrug

    One puff, 4 times daily by oral inhalation

  • AtroventDrug

    Two puffs, 4 times daily by oral inhalation

  • PlaceboDrug

Study groups in NCT02177344
Study groupRoleWhat they receive
Low dose of ipratropium bromideExperimentalNot described
Receives: Drug: Low dose of Ipratropium bromide
High dose of Ipratopium bromideExperimentalNot described
Receives: Drug: High dose of Ipratropium bromide
AtroventActive comparatorNot described
Receives: Drug: Atrovent
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Area under the curve from 0 to 6 hours (AUC0-6) for average of forced expiratory volume in 1 second (FEV1)

    Measured: up to day 169

Secondary outcomes (16)

  1. Peak FEV1 post treatment

    Measured: up to day 169

  2. Onset of therapeutic FEV1 response

    Measured: up to day 169

  3. Duration of therapeutic FEV1 response

    Measured: up to day 169

  4. Time to peak FEV1 response

    Measured: up to day 169

  5. Total area under the curve from 0 to 6 hours (TAUC0-6) for average FEV1 response

    Measured: up to day 169

  6. Average change in forced vital capacity (FVC) from zero to six hours

    Measured: up to day 169

  7. Peak FVC post treatment

    Measured: up to day 169

  8. Peak expiratory flow rate (PEFR) measured by the patient at home two times daily

    Measured: up to day 169

  9. Amount of inhaled rescue medication used during the treatment period

    Measured: up to day 169

  10. Concomitant medication usage during the treatment period including steroids

    Measured: up to day 169

  11. Change in patient daily symptom assessments

    Measured: Baseline, up to day 169

  12. Number of patients with adverse events

    Measured: Up to day 169

  13. Changes in vital signs (pulse rate, blood pressure)

    Measured: Baseline, up to day 169

  14. Changes in laboratory tests

    Measured: Baseline, day 169

  15. Number of patients with significant changes in ECG (electrocardiogram)

    Measured: Baseline, day 169

  16. Changes in physical examination

    Measured: Baseline, day 169

Timeline

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

  1. First posted27 Jun 2014 (estimated)
  2. Study startAug 1998
  3. Primary completionOct 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02177344
Sponsor's protocol ID
244.2484
Status last verified
Jun 2014
First submitted
24 Jun 2014
Last updated
17 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low dose of Ipratropium bromide, High dose of Ipratropium bromide and Atrovent in people with Pulmonary Disease, Chronic Obstructive, 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 7 inclusion and 26 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 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Area under the curve from 0 to 6 hours (AUC0-6) for average of forced expiratory volume in 1 second (FEV1) (time frame: up to day 169). 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 NCT02177344.

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 17 Jul 2014.

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