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A Non-Interventional Safety Study of Balsamic Bactrim

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ClinicalTrials.gov Identifier: NCT02902640
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a pilot, observational and multicentric study of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Adult participants with acute bronchitis eligible for treatment with Balsamic Bactrim will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.

Condition or disease Intervention/treatment
Bronchitis Drug: Guaifenesin Drug: Sulfamethoxazole Drug: Trimethoprim

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult Patients With Acute Bronchitis
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  2. Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  3. Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  4. Percentage of Participants With Balsamic Bactrim Dose Interruption [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  5. Percentage of Participants With Balsamic Bactrim Treatment Discontinuation [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  6. Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  7. Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  8. 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 Day 1 up to end of observation (up to 10 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older 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) according to the treating physician's judgment

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 that do not permit the clinical evaluation of the participant according to the treating physician's criteria
  • Participants with severe hepatic parenchymal damage
  • Participants with severe renal failure making it difficult to monitor drug plasma concentration
  • Participants with hypersensitivity to any of Balsamic Bactrim active ingredients, excipients, and/or sulfas

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 ClinicalTrials.gov identifier (NCT number): NCT02902640


Locations
Peru
Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias
Lima, Peru, 15088
Clinica de Especialidades Medicas
Lima, Peru, Lima 41
Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH
Lima, Peru, Lima 41
Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
San Juan de Miraflores, Peru, 15801
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02902640     History of Changes
Other Study ID Numbers: ML30018
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
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
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs