Special Survey Long-term Treatment With Tiotropium on COPD

Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Asahikawa, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients of Chronic Obstructive Pulmonary Disease
Patients were expected to use the product for long period of time

Exclusion criteria

Patients with glaucoma
Patients with micturition disorder due to prostatic hyperplasia etc.
Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product

Treatment and study plan

Primary outcomes

Number of Patients With Adverse Events (AEs)

Time frame: Pre treatment and 52 weeks after the treatment

Number of patients with AEs
Number of Patients With Adverse Drug Reactions (ADRs)

Time frame: Pre treatment and 52 weeks after the treatment

Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.

Secondary outcomes

Effective Rate of Comprehensive Evaluation

Time frame: 52 weeks

Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.

Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation".

"comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients
Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks

Time frame: Pre treatment and 52 weeks after the treatment

Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Special Survey Long-term Treatment

Important dates

Study start: 2005
Primary completion: 2009
First posted: Mar 18, 2008
Registry last updated: Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed