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Trial record 33 of 43 for:    "Bronchial Disease" | "Azithromycin"

Antibiotic Treatment of Recurrent Episodes of Asthma in Children (AB-studie)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233297
Recruitment Status : Active, not recruiting
First Posted : November 3, 2010
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Hans Bisgaard, Copenhagen Studies on Asthma in Childhood

Brief Summary:
Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.

Condition or disease Intervention/treatment Phase
Childhood Asthma With Acute Exacerbation Drug: Azithromycin Other: Placebo mixture Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Study Start Date : November 2010
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Asthma

Arm Intervention/treatment
Active Comparator: Antibiotics
Azithromycin (10 mg/kg once a day for 3 days)
Drug: Azithromycin
10 mg/kg peroral for 3 consecutive days

Placebo Comparator: Placebo
Placebo mixture (once a day for 3 days)
Other: Placebo mixture
Placebo mixture containing no active substance.




Primary Outcome Measures :
  1. Symptom scoring [ Time Frame: 1 to 3 years of age ]
  2. Duration in days of each asthmatic episode from randomisation start [ Time Frame: 1 to 3 years of age ]

Secondary Outcome Measures :
  1. need for PO steroids during the episode [ Time Frame: 1 to 3 years of age ]
  2. beta-agonist use during the asthmatic episode [ Time Frame: 1 to 3 years of age ]
  3. time lapse until the next asthmatic episode [ Time Frame: 1 to 3 years of age ]
  4. MD assessment of the episode [ Time Frame: 1 to 3 years of age ]
  5. Family's assessment of the episode [ Time Frame: 1 to 3 years of age ]
  6. Asthma related health and economic assessment [ Time Frame: 1 to 3 years of age ]
  7. percentage of time away from kindergarten or, for the parents, away from work [ Time Frame: 1 to 3 years of age ]
  8. stratification of the above parameters according to bacterial colonisation of the airways [ Time Frame: 1 to 3 years of age ]


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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the COPSAC2010 cohort
  • recurrent wheeze
  • and others

Exclusion Criteria:

  • Macrolide allergy
  • Heart, liver or kidney disease.
  • and others

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): NCT01233297


Locations
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Denmark
Copsac, DBAC
Gentofte, Copenhagen, Denmark, 2820
Copsac, Næstved Hospital, Pediatric Department
Naestved, Denmark, 4700
Sponsors and Collaborators
Copenhagen Studies on Asthma in Childhood
Investigators
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Principal Investigator: Hans Bisgaard, MD, DMSc Copenhagen Studies on Asthma in Childhood

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Hans Bisgaard, MD, DMSc, Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier: NCT01233297     History of Changes
Other Study ID Numbers: 2010-018592-16
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Keywords provided by Professor Hans Bisgaard, Copenhagen Studies on Asthma in Childhood:
wheeze
infections

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