Berodual® Respimat® vs Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease

NCT02176187 | Terminated Phase 3

• 1 other identifier: 215.1360
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the Respimat® inhaler and metered dose inhaler

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of dose in the whole lung

  Deposition of aerosol via gamma scintigraphy

  immediately after dosing

Secondary Outcomes (5)

• Percentage of dose in the central lung zone

  immediately after dosing

• Percentage of dose in the intermediate lung zone deposition

  immediately after dosing

• Percentage of dose in the peripheral lung zone deposition

  immediately after dosing

• Peripheral lung zone/central lung zone deposition ratio (lung penetration index)

  immediately after dosing

• Percentage of dose in oropharyngeal deposition

  immediately after dosing

Study Arms (2)

natural technique, without instructions

EXPERIMENTAL

randomised sequence of Berodual® Respimat® and Berodual® MDI

Drug: Berodual® Respimat® inhaler; Drug: Berodual® metered dose inhaler

optimal technique, with instructions

EXPERIMENTAL

randomised sequence of Berodual® Respimat® and Berodual® MDI

Drug: Berodual® Respimat® inhaler; Drug: Berodual® metered dose inhaler

Interventions

Berodual® Respimat® inhaler DRUG

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

natural technique, without instructions; optimal technique, with instructions

Berodual® metered dose inhaler DRUG

fenoterol hydrobromide 50μg + ipratropium bromide 20μg

natural technique, without instructions; optimal technique, with instructions

Eligibility Criteria

• Age: 18 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, mild to severe airway obstruction with an forced expiratory volulme in one second (FEV1) ≤70% of predicted normal and FEV1 ≤70% of forced vital capacity (FVC). Predicted normal values calculated according to evolutionary conserved chromosome segments (ECCS)
• Patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded
• Male or non-pregnant/non-lactating female patients aged ≥18 years
• Patients must demonstrate poor MDI technique prior to the start of the study. Presence of any of the following will be considered poor technique:
• Failure to co-ordinate "firing" of an MDI with inhalation
• Too fast an inhalation rate (\> 30 litres/minute (L/min))
• Presence of "Cold Freon" effect (MDI spray hitting the back of the throat that caused the patient to stop inhaling)
• All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications
• Current or ex-smokers with a smoking history of \>10 pack years

You may not qualify if:

• Patients with significant diseases other than COPD 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 unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year
• Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen
• 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 bronchiectasis
• Patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period
• Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit
• Patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo Berodual®
• Patients with known narrow-angle glaucoma
• Patients who are being treated with antihistamines (H1 receptor antagonists)
• Patients using oral corticosteroid medication at unstable doses (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
• Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg Depo-Provera or Noristerat contraceptives, intrauterine devices, diaphragm (plus spermicide) or subdermal implants eg: Norplant®)

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: April 1, 2003
• Primary Completion: December 1, 2004
• Last Updated: July 14, 2014

Record last verified: 2014-07