N/A Completed N=341

Drug Use Survey of RESPIMAT in Patients With COPD

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT01145053 ↗

Enrolled (actual)

341

Serious AEs

7.9%

Results posted

Jan 2013

Primary outcomePrimary: Incidence of Adverse Events (AEs) — 53; 16 Patients

Summary

To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs)	53; 16	—
SECONDARY Effectiveness	191; 122; 3	—
SECONDARY Forced Expiratory Volume in One Second (FEV1)	1.39; 1.46; 0.06	—
SECONDARY Cough Frequency	2.10; 1.62; -0.47	—
SECONDARY Amount of Sputum	2.05; 1.63; -0.42	—
SECONDARY Shortness of Breath	3.28; 2.69; -0.59	—
SECONDARY Nocturnal Sleep	1.55; 1.25; -0.31	—

Eligibility Criteria

Inclusion criteria

Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.

Exclusion criteria

There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01145053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.