NCT00327028

Brief Summary

The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

May 15, 2006

Last Update Submit

February 18, 2009

Conditions

Bronchial Asthma

Keywords

Bronchial asthmaPhenytoin, DiphenineAntiepileptic drugsEfficacy

Outcome Measures

Primary Outcomes (3)

  • At 3 months of treatment

  • Change from baseline of the PEFR and FEV1

  • Number of patients without asthma symptoms

Secondary Outcomes (4)

  • At 3 months of treatment

  • FEV1 before and after salbutamol inhalation

  • The daily (daytime and night-time) symptoms scores

  • Use of other antiasthmatic medication

Interventions

DiphenineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out patients
  • 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 acute or chronic severe diseases
  • Abnormal baseline haematology, blood chemistry or urinalysis
  • Allergy or adverse reactions to investigational drug
  • Age younger than 18 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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tamara Tchelidze, MD

    CRO Evidence

    STUDY DIRECTOR

  • Manana Pruidze, MD, PhD

    Centre of Chinese Medicine

    STUDY CHAIR

  • Merab Lomia, MD, PhD

    "Rea" Rehabilitation Centre

    PRINCIPAL INVESTIGATOR

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

May 15, 2006

First Posted

May 17, 2006

Study Start

September 1, 2005

Study Completion

December 1, 2005

Last Updated

February 19, 2009

Record last verified: 2009-02