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)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomized, Placebo-controlled, Within-device, Double-blind Tri-national Study to Compare the Safety and Efficacy of Berodual® Administered Via the Respimat® Device (50 µg Fenoterol Hydrobromide/20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide/10 µg Ipratropium Bromide, 1 Puff q.i.d) With That Administered Via the MDI (50 µg Fenoterol Hydrobromide/21 µg Ipratropium Bromide, 2 Puffs q.i.d) in COPD Patients Over a 12-week Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173782
• Other study ID #: 215.1349
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2014
• Last updated: July 11, 2014
• Start date: February 1998

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 892
• Est. primary completion date: April 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion

• 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

• Intolerance to aerosolised ipratropium- or fenoterol-containing products, or hypersensitivity to any of the MDI ingredients

• Oral corticosteroid mediation at dose greater than 10 mg prednisolone per day or equivalent

• Beta-blocker medication

• Changes in the pulmonary therapeutic plan within the last four weeks prior to the screening visit (not including withholding of medication before the screening visit)

• Concomitant or recent (within the last month) use of investigational drugs

• History of drug abuse and/or alcoholism

• Pregnant or nursing women and women of child-bearing potential not using a medically approved means of contraception

• Previous participation in this study (i.e. having been allocated a randomized treatment number)

• Patients with a history of asthma, allergic rhinitis or atopy or who have blood eosinophil count above 600/mm3 (a repeat eosinophil count will not be conducted in these patients) and those patients on antihistamines, anti-leukotrienes, sodium cromoglycate or nedocromil sodium

• Patients who are unable to comply with the medication restrictions specified in section 4.2 or who cannot use an MDI without a spacer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Berodual® Respimat ® high dose

• Berodual® Respimat ® low dose

• Berodual® MDI

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Average (FEV1) between 0 and 1 hour (AUC0-1h) in litres on previous test days		on day 1, 29, 57	No
Secondary	Forced vital capacity (FVC) in litres measured at the same time as FEV1		on day 1, 29, 57 and 85	No
Secondary	Peak FEV1 between 0 and 1 hour post inhalation of study drug		on day 1 and 85	No
Secondary	Onset of bronchodilatory response	Linear interpolation of the time of the first therapeutic response and the observation just prior to to the first therapeutic response. Therapeutic response was defined as FEV1 measurement exceeding 1.15 times of the pre-dose value that was recorded at any time point during the one hour observation period.	on day 1 and 85	No
Secondary	Peak expiratory flow (PEF) measured pre-medication, morning and evening, averaged weekly		up to 12 weeks	No
Secondary	Symptom scores recorded on the patient diary card		up to 12 weeks	No
Secondary	Use of rescue bronchodilator medication		up to 12 weeks	No
Secondary	Number of patients with adverse events		up to 12 weeks	No
Secondary	Total average FEV1 (TAUC0-1h)		day 85	No
Secondary	Number of patients with clinically significant changes in vital signs		up to 12 weeks	No
Secondary	Number of patients with clinically significant changes in laboratory parameters		Baseline and day 85	No
Secondary	Number of patients with abnormal findings in physical examination		Baseline and day 85	No
Secondary	Number of patients with clinically significant changes in electrocardiogram		Baseline and day 85	No

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