Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT02172352 | Completed Phase 2

• 1 other identifier: 205.139
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• FEV1.0 max (maximum forced expiratory volume in one second)

  before and up to 24 hours after each study drug administration

Secondary Outcomes (17)

• FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)

  before and up to 24 hours after each study drug administration

• FEV1.0 time to response

  before and up to 24 hours after each study drug administration

• FEV1.0 Tmax (time to FEV1.0 max)

  before and up to 24 hours after each study drug administration

• FEV1.0 at measuring time points up to 24 hours after administration of study drug

  before and up to 24 hours after each study drug administration

• FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)

  before and up to 24 hours after each study drug administration

Study Arms (4)

Ba 679 BR low dose

EXPERIMENTAL

Drug: Ba 679 BR low dose

Placebo inhalation powder

PLACEBO COMPARATOR

Drug: Placebo inhalation powder

Ba 679 BR middle dose

EXPERIMENTAL

Drug: Ba 679 BR middle dose

Ba 679 BR high dose

EXPERIMENTAL

Drug: Ba 679 BR high dose

Interventions

Ba 679 BR low dose DRUG

Ba 679 BR low dose

Ba 679 BR middle dose DRUG

Ba 679 BR middle dose

Ba 679 BR high dose DRUG

Ba 679 BR high dose

Placebo inhalation powder DRUG

Placebo inhalation powder

Eligibility Criteria

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

You may qualify if:

• In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
• In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
• History of smoking (\< no. of cigarettes a day x no. of years of smoking \> = 200 or more)
• years of age or older
• Regardless of sex and the length of disease period

You may not qualify if:

• A history of bronchial asthma
• A history of atopic disease, such as allergic rhinitis
• Blood eosinophil of 440/µl or more
• Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
• A history of respiratory infection, including virus infection within 1 month before study initiation
• Tuberculosis, lung cancer or a history of pneumonectomy
• Glaucoma
• Under treatment of benign prostatic hypertrophy
• Hypersensitivity to anticholinergic agents or sympathomimetics
• Difficulty in expectoration of sputum
• Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
• Use of any β blockers
• A history of myocardial infarction within the past 1 year
• A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
• A history of drug abuse or alcoholism

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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: July 1, 1998
• Primary Completion: May 1, 1999
• Last Updated: June 24, 2014

Record last verified: 2014-06