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Trial record 17 of 43 for:    "Bronchial Disease" | "Azithromycin"

Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children

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ClinicalTrials.gov Identifier: NCT01008761
Recruitment Status : Unknown
Verified July 2012 by Janielee Williamson, Alberta Children's Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2009
Last Update Posted : July 12, 2012
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Janielee Williamson, Alberta Children's Hospital

Brief Summary:
To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.

Condition or disease Intervention/treatment Phase
Asthma Drug: Azithromycin Drug: Suspension Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children
Study Start Date : January 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zithromax, 100 mgmgs; 5mls suspension
Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)
Drug: Azithromycin
Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)
Other Name: Azithromycin, zithromax, macrolide

Placebo Comparator: Suspension placebo,
placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.
Drug: Suspension Placebo
Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg
Other Name: Azithromycin




Primary Outcome Measures :
  1. To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly [ Time Frame: Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months ]

Secondary Outcome Measures :
  1. Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo [ Time Frame: Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months ]
  2. Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo. [ Time Frame: Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months ]


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Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12-60 months
  • wheeze on auscultation

Exclusion Criteria:

  • antibiotic use in the past 30 days
  • macrolide allergy
  • underlying medical condition
  • significant co-morbidities
  • current enrollment
  • language barrier or no access to phone for follow up

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): NCT01008761


Contacts
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Contact: Janielee Williamson, RN 403-955-3186 janie.williamson@albertahealthservices.ca
Contact: David W. Johnson, MD 403-955-7507 david.johnson@alberthealthservices.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Janielee Williamson, RN    403-955-3186    janie.williamson@albertahealthservices.ca   
Contact: Paula Finnson    403-955-7873    paula.finnson@albertahealthservices.ca   
Principal Investigator: David Johnson, MD         
Sub-Investigator: Sheldon Spier, MD         
Sub-Investigator: James D Kellner, MD         
Sub-Investigator: Candice Bjornson, MD         
Sub-Investigator: Michael Surrette, PhD         
Sub-Investigator: Alberto Nettle-Aguire, PhD         
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2V7
Contact: Piush Mandhane, MD       piush.mandhane@albertahealthservices.ca   
Principal Investigator: Piush Mandhane, MD         
Sub-Investigator: William Craig, MD         
Sub-Investigator: Darryl Adamko, MD         
Sub-Investigator: Bonita Lee, MD         
Sub-Investigator: Carina Majaesic, MD         
Sponsors and Collaborators
Janielee Williamson
University of Alberta
Investigators
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Principal Investigator: David W Johnson, MD Alberta children's Hospital/University of Calgary
Principal Investigator: Piush Mandhane, MD Stollery Children's Hospital Edmonton

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Responsible Party: Janielee Williamson, CCCRP Research Coordinator, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT01008761     History of Changes
Other Study ID Numbers: ALAWhZy2010
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Janielee Williamson, Alberta Children's Hospital:
Pre-school child
Wheezy episode

Additional relevant MeSH terms:
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Bronchial Diseases
Azithromycin
Asthma
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents