Berodual® Respimat® Versus Berodual® Metered Aerosol (MA) Inhaler in Patients With Asthma, Chronic Obstructive Pulmonary Disease, or Mixed Condition

NCT02173795 | Completed Phase 3

• 1 other identifier: 215.1357
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to investigate patients acceptability / preference of Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol (MA) inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life conditions was also evaluated.

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Outcome Measures

Primary Outcomes (1)

• Patient's assessment of inhaler preference

  patient preference questionnaire

  Day 98

Secondary Outcomes (6)

• Rating of inhaler satisfaction

  Day 49 and 98

• Rating of willingness to continue using inhaler

  Day 98

• Post-dose PEFRpm (Peak expiratory flow rate)

  30 minutes post-dose up to day 98

• Retention of inhaler technique

  day 49 and 98 (after 7 weeks of treatment)

• Use of rescue medication

  up to day 98

Study Arms (1)

Berodual® Respimat® - Berodual® MA HFA

EXPERIMENTAL

randomized sequence 1. Berodual® Respimat® (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per actuation for 49 days) 2. Berodual® MA HFA (20 µg ipratropium bromide + 50 µg fenoterol hydrobromide per puff for 49 days)

Drug: Berodual® Respimat®; Drug: Berodual® MA HFA

Interventions

Berodual® Respimat® DRUG

Berodual® Respimat® - Berodual® MA HFA

Berodual® MA HFA DRUG

Berodual® Respimat® - Berodual® MA HFA

Eligibility Criteria

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

You may qualify if:

• Diagnosis of chronic obstructive pulmonary disease, asthma, or mixed conditions for a minimum of 6 months
• Male or female patients 18 years of age or older
• Patients who use at least 2 puffs t.i.d. of Berodual® MA HFA on regular use or at least 4 weeks prior to study
• Patients should be able to perform all study related tests including using a peak flow meter, to perform acceptable PEFR measurements, and should be able to maintain records (Patient Daily Diary Cards) during the study period as required in the protocol
• All patients must sign and Informed Consent Form prior to participation in the trial, i.e., prior to the run-in period in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)

You may not qualify if:

• Patients with significant disease other than chronic airways obstruction (CAO) will 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 a recent history (i.e., six months - or less) of myocardial infarction
• Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalized for heart failure within the past three years, including patients with hypertrophic cardiomyopathy and tachyarrhythmia
• Patients who regularly use oxygen therapy
• Patients with known active tuberculosis
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
• Patients with any upper or lower respiratory infection in the past six weeks prior to the screening visit (Visit 1) or during the run-in period
• Patients hospitalized or having had visits to the emergency room in the past six weeks before run-in period
• Patients who are currently in a pulmonary rehabilitation programme that will not be maintained throughout the duration of the study or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit (Visit 1)
• Patients with known hypersensitivity to anticholinergic drugs or any other components of the trial medication including excipients
• Patients medically treated for prostatic hyperplasia or bladder neck obstruction
• Patients with known narrow-angle glaucoma or raised intra-ocular pressure
• Patients who are being treated with beta-blocker medications Note: beta1-blocker eye medications for treatment of non-narrow angle glaucoma are allowed
• Patients using oral corticosteroid medication at unstable dose (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: October 1, 2002
• Primary Completion: June 1, 2003
• Last Updated: July 14, 2014

Record last verified: 2014-07