NCT02172807

Brief Summary

Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Trough forced expiratory volume in one second (FEV1.0) response

    Day 1, week 2 and 4

Secondary Outcomes (13)

  • FEV1.0 response at 1 hour after administration

    Day 1, week 2 and 4

  • Trough forced vital capacity (FVC) response

    Day 1, week 2 and 4

  • FVC response at 1 hour after administration

    Day 1, week 2 and 4

  • Peak expiratory flow rate (PEF)

    in the morning and at evening every day until week 4

  • COPD symptom scores

    until week 4

  • +8 more secondary outcomes

Study Arms (3)

Tiotropium low & Placebo

EXPERIMENTAL

Tiotropium 18 µg inhalation capsule and Placebo MDI

Drug: Tiotropium lowDrug: Placebo MDI

Tiotropium high & Placebo

EXPERIMENTAL

Tiotropium 36 µg inhalation capsule and Placebo MDI

Drug: Tiotropium highDrug: Placebo MDI

Oxitropium & Placebo

ACTIVE COMPARATOR

Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules

Drug: Placebo inhalation capsuleDrug: Oxitropium

Interventions

Tiotropium lowDRUG

Tiotropium 18 µg inhalation capsule

Tiotropium low & Placebo
Tiotropium highDRUG

Tiotropium 36 µg inhalation capsule

Tiotropium high & Placebo
Placebo MDIDRUG

Placebo metered dose inhaler (MDI)

Tiotropium high & PlaceboTiotropium low & Placebo
Placebo inhalation capsuleDRUG
Oxitropium & Placebo
OxitropiumDRUG

Oxitropium MDI (100 µg/puff)

Also known as: Tersigan®
Oxitropium & Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:
  • Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
  • Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
  • Male or female patients 40 years of age or older

You may not qualify if:

  • History of bronchial asthma
  • History of an atopic disease such as allergic rhinitis
  • Total blood eosinophil count ≥ 600/µL
  • Patient treated with antiallergic drugs or anti-histamine drugs
  • Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
  • Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
  • Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
  • Patients with known narrow-angle glaucoma
  • Patients with known symptomatic prostatic hypertrophy
  • Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
  • Patients with significant diseases who in the opinion of the investigator were not eligible for the study
  • Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
  • Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
  • Patients with any cardiac arrhythmia requiring drug therapy
  • Patients who were treated with Patients who were treated with β-blockers-blockers
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

oxitropium

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological 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 20, 2014

First Posted

June 24, 2014

Study Start

December 1, 2000

Primary Completion

September 1, 2001

Last Updated

June 24, 2014

Record last verified: 2014-06