Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Childre

Not Applicable

• Conditions: -J45; J45

• Registration Number: PER-048-05
• Lead Sponsor: IVAX RESEARCH, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Children with an age between 5 and 11 years old.
2. Documented clinical evidence of asthma for a minimum of six months and that has been stable for at least 30 days.
3. The ability to perform an acceptable and reproducible spirometry.
4. The ability to make the determinations of the PEF.
5. Reversible bronchoconstriction.
6. Children must be healthy, with a medical history
clinically acceptable
7. The parent or guardian must be willing to provide written informed consent.

Exclusion Criteria

1. The patient has used inhaled corticosteroids within the previous 30 days.
2. The patient has allergy or sensitivity to BDP or other components of the formulations used in the MEC.
3. The patient shows an increase or decrease in FEVi> 20% between the screening visit and the baseline.
4. The patient is not willing to use an MDI without a spacer device.
5. The patient requires using> 12 aspirations per day of albuterol for 3 consecutive days.
6. There is evidence that the patient has growth retardation.
7. The patient has been treated with methotrexate, cyclosporine, gold or other cytotoxic agents.
8. The patient is receiving step doses of immunotherapy,
oral immunotherapy or immunotherapy for short-course rhinitis.
9. There is evidence that the patient has oropharyngeal candidiasis.
10. The patient had exposure to investigational drugs within the previous 30 days.
11. The patient requires continuous treatment with B-blockers, MAO inhibitors, tricyclic antidepressants, anticholinergics, inhaled cromoline or nedocromil, nebulizer therapy after the screening visit.
12. The patient is unable to tolerate or unwilling to comply with the appropriate detoxification periods for all applicable medications.
13. The patient has had treatment at some time for asthmatic episodes that have threatened the patient´s life.
14. The patient has received any of the following treatments or has met any of the following conditions within the six weeks prior to the screening visit: Oral or injected corticosteroids, an upper respiratory tract infection and / or sinusitis associated with exacerbation of asthmatic symptoms, treatment in the emergency room or hospitalization due to asthmatic symptoms.
15. History and / or presence of acute or chronic non-asthmatic lung disease.
16. Presence of cardiovascular disease.
17. History of glaucoma or cataracts.
18. Presence of systemic infections by fungi, bacteria, parasites or a viral infection.
19. Improbability to adhere to treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified