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Drug Use Survey of RESPIMAT in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01145053
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : January 30, 2013
Last Update Posted : March 27, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease
Pulmonary Disease, Chronic Obstructive

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Study Type : Observational
Actual Enrollment : 361 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Time Survey of RESPIMAT in Daily Clinical Use
Study Start Date : May 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Week 52 ]
    The number of patient with any AEs, patients with drug-related AEs

Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: Week 52 ]
    Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.

  2. Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Week 0 and Week 52 ]
    FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.

  3. Cough Frequency [ Time Frame: Week 0 and Week 52 ]
    Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.

  4. Amount of Sputum [ Time Frame: Week 0 and Week 52 ]
    Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.

  5. Shortness of Breath [ Time Frame: Week 0 and Week 52 ]
    Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.

  6. Nocturnal Sleep [ Time Frame: Week 0 and Week 52 ]
    Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01145053

Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim Identifier: NCT01145053    
Other Study ID Numbers: 205.463
First Posted: June 16, 2010    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: March 27, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive