SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00879008
• Collaborator: (none)
• Enrollment: 345
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 43.2

Study Details

Study Description

Brief Summary

In this study data of patients with moderate or severe acute exacerbations of chronic bronchitis (AECB) were collected. There were two different cohorts which were compared (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a prospective study which was accomplished in 100 ambulatory practice offices.

Condition or Disease	Intervention/Treatment	Phase
Chronic Bronchitis	Drug: Moxifloxacin (Avelox, BAY12-8039)

Detailed Description

The study design was slightly changed to adapt the target population. Due to these changes the study was restarted on 8th December 2009.

Study Design

• Study Type: Observational
• Actual Enrollment: 345 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Moxifloxacin (Avelox, BAY12-8039); Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information

Outcome Measures

Primary Outcome Measures

1. Effectiveness and tolerance of/to the different therapies [within the first 14 days]

2. Possible hospitalisation rate [within the first 14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute exacerbation of chronic bronchitis from Anthonisen type I or II

• FEV1 of < 50 %

• Patient must be ensured in the statutory health insurance

• Further contraindications of the prescribed pharmaceutical products must be considered

Exclusion Criteria:

• Patients who change from one cohort to the other

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Germany

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00879008
• Other Study ID Numbers: 12629; AX0710DE
• First Posted: Apr 9, 2009
• Last Update Posted: Jun 23, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Bayer: Disease Exacerbation; Acute Exacerbations of Chronic Bronchitis; AECB; Avelox; Bronchitis
• Additional relevant MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Jun 23, 2014