Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients

NCT02242279 | Completed Phase 2

• 1 other identifier: 1205.3
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the dose-dependent bronchodilator effect and the safety of single inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with stable Chronic Obstructive Pulmonary Disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change in Mean Forced Expiratory Volume in 1st second (FEV1)

  23 and 24 hours after single inhalation

Secondary Outcomes (15)

• Change in FEV1 Area under the concentration-time curve over the respective time interval (AUCtime-interval)

  predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose

• Peak FEV1

  within 3 hours after inhalation of each single dose

• Time to peak bronchodilatory response

  within 3 hours after inhalation of each single dose

• Change in Forced Vital Capacity (FVC) AUCtime-interval

  predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose

• Change in individual FEV1 measurements

  up to 71 days

Study Arms (5)

BEA 2180 - low dose

EXPERIMENTAL

Drug: BEA 2180 BR

BEA 2180 - medium dose

EXPERIMENTAL

Drug: BEA 2180 BR; Drug: Placebo

BEA 2180 - high dose

EXPERIMENTAL

Drug: BEA 2180 BR

Tiotropium

ACTIVE COMPARATOR

Drug: Tiotropium

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BEA 2180 BR DRUG

BEA 2180 - high dose; BEA 2180 - low dose; BEA 2180 - medium dose

Tiotropium DRUG

Tiotropium

Placebo DRUG

BEA 2180 - medium dose; Placebo

Eligibility Criteria

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

You may qualify if:

• All patients have to sign and date an informed consent consistent with International committee on harmonisation (ICH) - Good Clinical Practice (GCP) guidelines prior to participation in the trial, which included medication washout and restrictions
• All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
• Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
• All patients must have an increase in FEV1 of at least 12% from baseline 45 min after inhalation of 80 μg of ipratropium inhaled via Hydro Fluoro Alkane (HFA) - Metered Dose Inhaler (MDI)
• Male or female patients 40 years of age or older. Female patients of child bearing potential could not participate in this study
• Patients must be current or ex-smokers with a smoking history of more than 10 pack/years
• (Patients who have never smoked cigarettes must be excluded)
• Patients must be able to perform technically acceptable pulmonary function tests and inhale medication in a competent manner from the Respimat® device and the HandiHaler®

You may not qualify if:

• Patients with significant diseases other than Chronic Obstructive Pulmonary Disease (COPD) must 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 hematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease
• Patients with significant prostatic hyperplasia
• Patients with a recent history (i.e. one year or less) of myocardial infarction
• Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalized for such an event within the past year
• Patients with a history (less than 3 years) of cardiac failure, cor pulmonale or cardiac arrhythmia requiring drug therapy
• Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
• Patients with known narrow-angle glaucoma
• Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not conducted in these patients
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
• Patients with known active tuberculosis
• Patients with a history of and/or active significant alcohol or drug abuse
• Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons must be excluded
• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
• Patients who regularly used daytime oxygen therapy

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: June 1, 2004
• Primary Completion: December 1, 2004
• Last Updated: September 17, 2014

Record last verified: 2014-09