NCT00153296

Brief Summary

The purpose of this study was to determine whether antiepileptic drug carbamazepine is effective in the treatment of chronic moderate persistent and severe asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2004

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

August 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

September 8, 2005

Last Update Submit

February 18, 2009

Conditions

Bronchial Asthma

Keywords

Bronchial asthmaCarbamazepineAntiepileptic drugsEfficacy

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

CarbamazepineDRUG

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have given their informed consent before commencing the procedures specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.
  • Males or females.
  • Patient aged between 16 and 65 years.
  • Out patients.
  • Non smokers or ex-smokers, having stopped smoking \> 1 year.
  • Moderate persistent or severe asthma, according GINA classification
  • Patients with an established (i.e. at least one year) clinical history of asthma.
  • Absence of long-term remissions of asthma (lasting more than 1 month)
  • Poorly controlled asthma, due to various reasons.
  • Patients with a FEV1 reversibility of at least 12% from initial level after 400 mcg salbutamol inhalation (4 puffs of salbutamol MDI, 100 mcg per puff). Patients whose FEV1 reversibility was 12% within the past 12 months are acceptable, providing that the records are available to the investigator.
  • Patients able to swallow capsules, able to understand and complete diary cards and to record their PEFR using a peak-flow meter.

You may not qualify if:

  • Long-term history of smoking (3 years and more)
  • History or presence of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
  • Patients with a recent history (\< 1 year) of myocardial infarction and/or (\< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
  • History of cancer within the past 5 years.
  • Patients with active tuberculosis with indication for treatment.
  • Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or emphysema.
  • Patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
  • Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
  • Pregnant or nursing women and sexually active women with childbearing potential not using a medically approved method of contraception.
  • Patients unlikely, unable or unwilling to comply with the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lomia M, Tchelidze T, Pruidze M. Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine. Respir Med. 2006 Nov;100(11):1988-96. doi: 10.1016/j.rmed.2006.02.018. Epub 2006 Apr 4.

    PMID: 16597501RESULT

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Merab Lomia, MD, PhD

    "Rea" Rehabilitation Centre

    PRINCIPAL INVESTIGATOR

  • Tamuna Tchelidze, MD

    CRO Evidence

    STUDY DIRECTOR

  • Manana Tchaia, MD

    Centre of Chinese Medicine

    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 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Study Completion

April 1, 2005

Last Updated

February 19, 2009

Record last verified: 2009-02