N/A
Completed N=10
Effect of Symbicort on GR Localisation in Asthma
Source: ClinicalTrials.gov NCT00159263 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Changes in GR-GRE Binding — 1.4; 1.4; 1.6; 2.3 GRE activity (OD) — p=0.04
Summary
To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in GR-GRE Binding |
1.4; 1.4; 1.6; 2.3; 3.5; 3 | 0.04 sig |
| PRIMARY Changes in MKP-1 mRNA |
1; 3; 3; 4; 5; 5 | 0.01 sig |
| PRIMARY IL8 mRNA |
1; 4; 4; 0.4; 0.2; 0.2 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with mild steroid-naïve asthma (ATS criteria) of either sex with FEV1 >70 % pred
- Able to produce sputum after sputum induction
- Exhaled NO (flow 50 ml/s) ≥ 20 ppb
- Written informed consent
Exclusion Criteria
- Current upper respiratory tract infections
- Use of inhaled and/or oral GCS within 4 weeks prior to visit 1
- Treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
- Hypersensitivity to any of the investigational drugs or lactose
- Use of any beta blocking agent (including eye-drops)
- Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
- Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
- Inability to tolerate temporary withdrawal of bronchodilatory therapy
- Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
- Previous randomization in this study
Data sourced from ClinicalTrials.gov (NCT00159263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.