Trial Outcomes & Findings for Special Survey Long-term Treatment With Tiotropium on COPD (NCT NCT00638183)

NCT ID: NCT00638183

Last Updated: 2014-06-19

Results Overview

Number of patients with AEs

• Recruitment status: COMPLETED
• Target enrollment: 385 participants
• Primary outcome timeframe: Pre treatment and 52 weeks after the treatment
• Results posted on: 2014-06-19

Participant Flow

Participant milestones

Measure	Spiriva Treatment Daily Therapy
Overall Study STARTED	385
Overall Study COMPLETED	266
Overall Study NOT COMPLETED	119

Reasons for withdrawal

Measure	Spiriva Treatment Daily Therapy
Overall Study Adverse Event	23
Overall Study Lack of Efficacy	14
Overall Study Physician Decision	9
Overall Study Lost to Follow-up	46
Overall Study Other reason not defined above	27

Baseline Characteristics

Special Survey Long-term Treatment With Tiotropium on COPD

Baseline characteristics by cohort

Measure	Spiriva Treatment n=249 Participants Daily Therapy
Age, Customized <65 years	51 Participants n=5 Participants
Age, Customized 65≤ to <75 years	88 Participants n=5 Participants
Age, Customized >=75 years	103 Participants n=5 Participants
Age, Customized Unknown	7 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	212 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre treatment and 52 weeks after the treatment

Population: 373 patients were involved in the safety analysis data

Number of patients with AEs

Outcome measures

Measure	Spiriva Treatment n=373 Participants Daily Therapy
Number of Patients With Adverse Events (AEs)	71 Participants

PRIMARY outcome

Timeframe: Pre treatment and 52 weeks after the treatment

Population: 373 patients were involved in the safety analysis data

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

Outcome measures

Measure	Spiriva Treatment n=373 Participants Daily Therapy
Number of Patients With Adverse Drug Reactions (ADRs)	27 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: 249 patient were evaluated the efficacy

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

Outcome measures

Measure	Spiriva Treatment n=249 Participants Daily Therapy
Effective Rate of Comprehensive Evaluation	70.9 percentage of effective patients

SECONDARY outcome

Timeframe: Pre treatment and 52 weeks after the treatment

Population: All patients for which respiratory function testing was conducted at baseline and at 52 weeks

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

Outcome measures

Measure	Spiriva Treatment n=111 Participants Daily Therapy
Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks	0.119 Liters Standard Deviation 0.208

Adverse Events

Spiriva Treatment

Serious events: 33 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spiriva Treatment n=373 participants at risk Daily Therapy
Infections and infestations Bronchitis	0.27% 1/373 • 52 Weeks
Infections and infestations Diverticulitis	0.27% 1/373 • 52 Weeks
Infections and infestations Infection	0.54% 2/373 • 52 Weeks
Infections and infestations Pneumonia	1.6% 6/373 • 52 Weeks
Infections and infestations Sepsis	0.27% 1/373 • 52 Weeks
Infections and infestations Lung infection	0.27% 1/373 • 52 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.27% 1/373 • 52 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.27% 1/373 • 52 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.27% 1/373 • 52 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.54% 2/373 • 52 Weeks
Nervous system disorders Cerebral infarction	0.27% 1/373 • 52 Weeks
Nervous system disorders Dizziness	0.27% 1/373 • 52 Weeks
Nervous system disorders Loss of consciousness	0.27% 1/373 • 52 Weeks
Nervous system disorders Stupor	0.27% 1/373 • 52 Weeks
Eye disorders Macular degeneration	0.27% 1/373 • 52 Weeks
Cardiac disorders Angina pectoris	0.27% 1/373 • 52 Weeks
Cardiac disorders Cardiac failure	0.54% 2/373 • 52 Weeks
Cardiac disorders Cardiac failure congestive	0.27% 1/373 • 52 Weeks
Cardiac disorders Bradyarrhythmia	0.27% 1/373 • 52 Weeks
Cardiac disorders Left atrial dilatation	0.27% 1/373 • 52 Weeks
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/373 • 52 Weeks
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.3% 5/373 • 52 Weeks
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.27% 1/373 • 52 Weeks
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.54% 2/373 • 52 Weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.54% 2/373 • 52 Weeks
Gastrointestinal disorders Colonic polyp	0.27% 1/373 • 52 Weeks
Gastrointestinal disorders Ileus	0.27% 1/373 • 52 Weeks
Gastrointestinal disorders Pancreatitis acute	0.27% 1/373 • 52 Weeks
Renal and urinary disorders Neurogenic bladder	0.27% 1/373 • 52 Weeks
General disorders Death	0.27% 1/373 • 52 Weeks
Injury, poisoning and procedural complications Rib fracture	0.27% 1/373 • 52 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.27% 1/373 • 52 Weeks
Cardiac disorders Cor pulmonale	0.27% 1/373 • 52 Weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
• Publication restrictions are in place

Restriction type: OTHER