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

NCT02236182 | Completed Phase 2

• 1 other identifier: 244.2489
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (6)

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

  Pre-treatment, on Day 7 and 13

• Number of patients with adverse events

  Up to 15 days after first drug administration

• Number of patients with clinical significant findings in ECG

  Up to 15 days after first drug administration

• Number of patients with clinical significant findings in vital signs

  Up to 15 days after first drug administration

• Number of patients with clinical significant findings in laboratory tests

  Up to day 15 after drug administration

• Number of patients with paradoxical bronchospasm

  Up to 15 days after first drug administration

Secondary Outcomes (10)

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

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

• Peak FEV1

  On Day 1 and 14

• Onset of therapeutic FEV1 response

  On Day 1 and 14

• Time to peak FEV1 response

  On Day 1 and 14

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

  Day 14

Study Arms (3)

Ipratropium Bromide low

EXPERIMENTAL

delivered via RESPIMAT®

Drug: Ipratropium Bromide low dose

Ipratropium Bromide high

EXPERIMENTAL

delivered via RESPIMAT®

Drug: Ipratropium Bromide high dose

Placebo

PLACEBO COMPARATOR

delivered via RESPIMAT®

Drug: Placebo

Interventions

Ipratropium Bromide low dose DRUG

Ipratropium Bromide low

Placebo DRUG

Placebo

Ipratropium Bromide high dose DRUG

Ipratropium Bromide high

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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))

You may not qualify if:

• 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
• 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
• 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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 10, 2014
• Study Start: July 1, 1998
• Primary Completion: February 1, 1999
• Last Updated: September 12, 2014

Record last verified: 2014-09