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Pulmonary Disease, Chronic ObstructivePhase 2NCT02236182

Study to Assess the Safety of Ipratropium Bromide, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Ipratropium Bromide low dose and Ipratropium Bromide high dose 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

Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG monitoring in COPD 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?
Ipratropium Bromide low dose and Ipratropium Bromide high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
No sites listed yet
Study dates
Jul 1998to Feb 1999
Phase
Phase 2
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 an FEV1 <=65% of predicted normal and FEV1 <=70% of forced vital capacity (FVC). Predicted normal value will be calculated according to Morris
  • Males: FEV1 = 0.093 (Height in inches)-0.032 (age)-1.343
  • Females: FEV1 = 0.085 (Height. in inches)-0.025(age)-1.692
  • Male or female patients 40 years of age or older
  • Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
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  • Patients must be able to perform pulmonary function tests (PFTs) 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
  • Patients must have a baseline electrocardiogram (ECG) with no clinical relevant arrhythmias or conduction system disease (e.g. right or left bundle branch block, second degree AV block or higher)
  • Patients must have an oxygen saturation of >=90% for >=92% of the recording time on overnight oximetry
  • All patients must sign an Informed Consent Form prior to participation in the trial (i.e., at least 24 hours (h) prior to the screening visit (Visit 1))

Who cannot join

  • Patients with clinically relevant diseases other than COPD will be excluded. A clinically relevant 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 with may influence the results of the study or patient's ability to participate in the study
  • Patients with a recent history (i.e. one year or less) of myocardial infarction
  • Patients with a recent history (i.e. one year or less) of heart failure or patients with any past history or active cardiac arrhythmia requiring drug therapy
  • Patients who have a pacemaker
  • Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion the patient is excluded
  • All patients with serum glutamic oxaloacetic transaminase / Aspartate aminotransferase (SGOT/AST) >80 IU/L, serum glutamic pyruvic transaminase / Alanine transaminase (SGPT/ALT) >80 IU/L, bilirubin >2.0 mg/dl, or creatinine >2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects
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  • Patients who have a blood eosinophil count >=600/mm3. A Repeat eosinophil count will be not be conducted in these patients
  • Patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 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 thoracotomy for other reason should be evaluated per exclusion criterion No. 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 6 weeks prior to the screening visit (Visit 1) or during the baseline period
  • Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
  • Patients with known narrow-angle glaucoma
  • 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 (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)
  • Patients with known hypersensitivity to ant cholinergic drugs or any other components of the ATROVENT® RESPIMAT™ solution including bacteriostatic agent benzalkonium chlorid (BAC) and edetic acid (EDTA)
  • Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) prior to the screening visit (visit1)
  • Previous participation in this study

About this study

Official title: A Double-blind, Placebo Controlled Trial to Assess the Safety of Two-week Administration of 80 mcg q.i.d. and 160 mcg q.i.d. of Ipratropium Bromide, as Delivered by the RESPIMAT® Device, in Patients With Chronic Obstructive Pulmonary Disease

Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium bromide as delivered by the RESPIMAT® device when administered over a two-week period.

Being tested
Ipratropium Bromide low dose, Placebo, Ipratropium Bromide high dose
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.

  • Ipratropium Bromide low doseDrug

  • PlaceboDrug

  • Ipratropium Bromide high doseDrug

Study groups in NCT02236182
Study groupRoleWhat they receive
Ipratropium Bromide lowExperimentaldelivered via RESPIMAT®
Receives: Drug: Ipratropium Bromide low dose
Ipratropium Bromide highExperimentaldelivered via RESPIMAT®
Receives: Drug: Ipratropium Bromide high dose
PlaceboPlacebo comparatordelivered via RESPIMAT®
Receives: Drug: Placebo

What is being measured

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

  1. Assessment of clinical significant findings in 24-hour ambulatory ECG monitoring

    Measured: Pre-treatment, on Day 7 and 13

  2. Number of patients with adverse events

    Measured: Up to 15 days after first drug administration

  3. Number of patients with clinical significant findings in ECG

    Measured: Up to 15 days after first drug administration

  4. Number of patients with clinical significant findings in vital signs

    Measured: Up to 15 days after first drug administration

  5. Number of patients with clinical significant findings in laboratory tests

    Measured: Up to day 15 after drug administration

  6. Number of patients with paradoxical bronchospasm

    Measured: Up to 15 days after first drug administration

Secondary outcomes (10)

  1. FEV1 (forced expiratory volume in the first second) AUC0-4 (Area under the curve from 0 to 4 hours)

    Measured: Pre-treatment, up to 4 h after drug administration on Day 1 and 14

  2. Peak FEV1

    Measured: On Day 1 and 14

  3. Onset of therapeutic FEV1 response

    Measured: On Day 1 and 14

  4. Time to peak FEV1 response

    Measured: On Day 1 and 14

  5. AUC(0-6h) (Area under the plasma concentration-time curve from 0 to 6 h)

    Measured: Day 14

  6. Cmax (maximum plasma concentration)

    Measured: Day 14

  7. Cmin(0h) (minimum plasma concentration before inhalation)

    Measured: Day 14

  8. Cmin(6h) (minimum plasma concentration at 6 hours after inhalation)

    Measured: Day 14

  9. Ae(0-2h) (urine excretion between 0 to 2 h)

    Measured: Day 14

  10. Ae(0-6h) (urine excretion between 0 to 6 h)

    Measured: Day 14

Timeline

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

  1. First posted10 Sep 2014 (estimated)
  2. Study startJul 1998
  3. Primary completionFeb 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236182
Sponsor's protocol ID
244.2489
Status last verified
Sep 2014
First submitted
9 Sep 2014
Last updated
12 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipratropium Bromide low dose and Ipratropium Bromide high dose 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 11 inclusion and 27 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 12 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Assessment of clinical significant findings in 24-hour ambulatory ECG monitoring (time frame: Pre-treatment, on Day 7 and 13). The study lists 6 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 NCT02236182.

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 12 Sep 2014.

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