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An Observational Study to Assess Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult Participants With Acute Bronchitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02902640
First received: September 13, 2016
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
This is a pilot, observational and multicentric study of safety of sulfamethoxazole plus (+) trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Overall, 50 adult participants with acute bronchitis eligible for treatment with sulfamethoxazole + trimethoprim + guaifenesin will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.

Condition Intervention
Bronchitis
Drug: Guaifenesin
Drug: Sulfamethoxazole
Drug: Trimethoprim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult Patients With Acute Bronchitis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of participants with adverse events related to sulfamethoxazole + trimethoprim + guaifenesin (as assessed by the investigator) [ Time Frame: From baseline up to 6 months ]

Secondary Outcome Measures:
  • Overall Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Dose Interruption [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Treatment Discontinuation [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific pre-defined factors, these will be decided based on observations during study) [ Time Frame: From baseline up to 3 months ]

Estimated Enrollment: 50
Study Start Date: November 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute Bronchitis Participants
Participants with acute bronchitis for whom the treating physician has decided to initiate treatment with Balsamic Bactrim, will be observed. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling. The study protocol does not enforce any treatment.
Drug: Guaifenesin
Guaifenesin will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
Drug: Sulfamethoxazole
Sulfamethoxazole will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
Drug: Trimethoprim
Trimethoprim will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label.
Criteria

Inclusion Criteria:

  • Participants starting treatment with Balsamic Bactrim as per treating physician's discretion
  • Participants with a clinical diagnosis of acute bronchitis (Cough with or without sputum production less than 30 days)

Exclusion Criteria:

  • Participants who have started treatment with another antibiotic at the time of the visit
  • Participants with no respiratory infections
  • Participants with mental disorders
  • Participants with severe hepatic parenchymal damage
  • Participants with severe renal failure if the drug plasma concentration cannot be monitored
  • Participants with hypersensitivity to any of its active ingredients or excipients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02902640

Contacts
Contact: Reference Study ID Number: ML30018 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
Peru
Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias Recruiting
Lima, Peru, 15088
Centro de Investigaciones Medicas/Hospital Maria Auxiliadora Recruiting
Lima, Peru, LIMA 29
Clinica de Especialidades Medicas Recruiting
Lima, Peru, Lima 41
Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH Recruiting
Lima, Peru, Lima 41
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02902640     History of Changes
Other Study ID Numbers: ML30018
Study First Received: September 13, 2016
Last Updated: February 7, 2017

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Sulfamethoxazole
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on March 28, 2017