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Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis (EASY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01032174
First received: December 14, 2009
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.


Condition Intervention
Maxillary Sinusitis
 Drug: Azithromycin SR
Drug: Amoxiclav 1000 mg

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Response of Very Convenient or Somewhat Convenient [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.


Secondary Outcome Measures:
  • Percent Compliance With Prescribed Treatment Regimen [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).

  • Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.


Enrollment: 123
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Azithromycin SR
Acute Bacterial Maxillary Sinusitis
 Drug: Azithromycin SR
Azithromycin SR, 2.0 g by mouth (PO) x 1
Amoxiclav 1000 mg
Acute Bacterial Maxillary Sinusitis
 Drug: Amoxiclav 1000 mg
Amoxiclav 1000 mg x twice daily, 10 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Acute Maxillary Sinusitis

Criteria

Inclusion Criteria:

  • Male or nor pregnant or lactating female outpatients, 18 years of age or older.

  • A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:

    1. Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
    2. Presence of one or more of the following signs:

    i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice

  • A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:

    1. complete or partial opacification
    2. an air/fluid level

Two or more of the following:

  1. fever, as defined by temperature: >38ºC
  2. leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;
  3. headache,
  4. nasal congestion and post nasal drainage.

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032174

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01032174     History of Changes
Other Study ID Numbers: A0661199
Study First Received: December 14, 2009
Results First Received: February 21, 2012
Last Updated: April 10, 2012
Health Authority: Russia: Ethics Committee

Keywords provided by Pfizer:
Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis

Additional relevant MeSH terms:
Maxillary Sinusitis
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Otorhinolaryngologic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013