Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02173782 | Completed Phase 3

• 1 other identifier: 215.1349
• Study Type: interventional
• Target: 892
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile is at least as good when COPD patients are treated for 12 weeks.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres

  after 12 weeks of treatment

Secondary Outcomes (13)

• Average (FEV1) between 0 and 1 hour (AUC0-1h) in litres on previous test days

  on day 1, 29, 57

• Forced vital capacity (FVC) in litres measured at the same time as FEV1

  on day 1, 29, 57 and 85

• Peak FEV1 between 0 and 1 hour post inhalation of study drug

  on day 1 and 85

• Onset of bronchodilatory response

  on day 1 and 85

• Peak expiratory flow (PEF) measured pre-medication, morning and evening, averaged weekly

  up to 12 weeks

Study Arms (4)

Berodual® Respimat ® high dose

EXPERIMENTAL

Drug: Berodual® Respimat ® high dose

Berodual® MDI

ACTIVE COMPARATOR

Drug: Berodual® MDI

Berodual® Respimat® low dose

EXPERIMENTAL

Drug: Berodual® Respimat ® low dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Berodual® Respimat ® high dose DRUG

Berodual® Respimat ® high dose

Berodual® Respimat ® low dose DRUG

Berodual® Respimat® low dose

Berodual® MDI DRUG

Berodual® MDI

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Age \>= 40 years
• Diagnosis of COPD according the following criteria:
• screening FEV1\<= 65% predicted
• Screening FEV1/FVC \<= 70%
• Smoking history \> 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent
• Able to be trained in the proper use of MDI and Respimat®
• Able to be trained in the performance of technically satisfactory pulmonary function tests
• All patients must be willing and able to sign informed consent in accordance with Good clinical Practice (GCP) and local legislation

You may not qualify if:

• History of cardiovascular, renal, neurologic, liver or endocrine dysfunction (e.g. hyperthyreosis) if they are clinically significant. A clinically significant disease is defined as one 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 or the study or the patient's ability to participate in the study
• Patients with a recent (\<= one year) history of myocardial infarction
• Tuberculosis with indication for treatment
• History of cancer within the last five years (excluding basal carcinoma)
• Patients who have undergone thoracotomy
• Current psychiatric disorders
• History of life-threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
• An upper and lower respiratory tract infection in the four weeks prior to the screening visit
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
• Patients with known narrow-angle glaucoma or raised intra-ocular pressure
• Patients with:
• Serum glutamic oxalo-acetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \>200% of the upper limit of the normal range
• Bilirubin \>150% of the upper limit of the normal range
• Creatinine \>125% of the upper limit of the normal range
• Patients who are on chronic oxygen therapy

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: February 1, 1998
• Primary Completion: April 1, 1999
• Last Updated: July 14, 2014

Record last verified: 2014-06