PreAsthmaControl (PAC)
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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: NCT00234390 |
Recruitment Status :
Completed
First Posted : October 7, 2005
Last Update Posted : January 24, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Pulmicort (budesonide) pMDI | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Prevention of Asthma in Infants/Young Children - PAC |
Study Start Date : | November 1998 |
Actual Study Completion Date : | December 2004 |

- symptom free days
- days with no use of bronchodilator
- days with no use of bronchodilator and no symptoms
- number of treated episodes
- number of treatment with add-on medication
- asthma status
- time to start of algorithm treatment
- the total steroid dose
- First treatment episode:
- number of symptom days
- number of days with use of bronchodilator
- number of patients who needed add-on medication
- BMD
- height
- serious adverse events

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 6 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children of asthmatic mothers form the COPSAC birth cohort study
Exclusion Criteria:
- Children born more than 4 weeks preterm
- children with other systemic illness that atopy/allergy
- Children requiring mechanical ventilation at any time since birth.

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): NCT00234390
Denmark | |
Research Site | |
Copenhagen, Denmark |
Study Director: | AstraZeneca AB CNS Medical Science Director, MD | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00234390 |
Other Study ID Numbers: |
SD-004-0299 |
First Posted: | October 7, 2005 Key Record Dates |
Last Update Posted: | January 24, 2011 |
Last Verified: | January 2011 |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |