NCT00142025

Brief Summary

The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is effective in the treatment of chronic asthma.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

September 1, 2005

Last Update Submit

February 18, 2009

Conditions

Bronchial Asthma

Keywords

Bronchial asthmaOxcarbazepineAntiepileptic drugEfficacy

Outcome Measures

Primary Outcomes (1)

  • At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Outcomes (1)

  • At 3 months of treatment: FEV1 before and after salbutamol inhalation; Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; Use of other antiasthmatic medication

Interventions

OxcarbazepineDRUG

Eligibility Criteria

Age17 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Bronchial asthma has been known at least for 1 year
  • Absence of long-term remissions of asthma (lasting more than 1 month)
  • Poorly controlled asthma, due to various reasons
  • Non-smokers

You may not qualify if:

  • Presence of concomitant severe diseases
  • Allergy or adverse reactions to carbamazepine or oxcarbazepine
  • Abnormal baseline haematology, blood chemistry or urinalysis
  • Current use of long-acting beta-agonists
  • Age younger than 16 years old
  • Long-term history of smoking
  • Pregnancy or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Merab Lomia, MD, PhD

    "Rea" Rehabilitation Centre.

    PRINCIPAL INVESTIGATOR

  • Manana Tchaia, MD

    Centre of Chinese Medicine

    STUDY DIRECTOR

  • Tamara Tchelidze, MD

    CRO Evidence

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

September 1, 2001

Study Completion

March 1, 2002

Last Updated

February 19, 2009

Record last verified: 2009-02