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Completed

NCT Number: NCT00207428

Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in the treatment of mild-to-severe bronchial asthma.

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Key information

About this study

Effective therapy of asthma still remains quite serious problem. According current opinion of leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal disorder: many specialists underline paroxysmal clinical picture of asthma. According to some authors, neurogenic inflammation may play important role in asthma mechanism. But migraine and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some antiepileptic drugs, like carbamazepine and valproates, are very effective in therapy of these diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, we can suppose a possibility that some antiepileptic drugs also may show high efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a double-blind, placebo-controlled 3-month trial for evaluation of carbamazepine efficacy in treatment of patients with mild-to-severe bronchial asthma.

Comparison: Patients received investigational drug in addition to their usual routine antiasthmatic treatment, compared to patients received placebo in addition to their usual routine antiasthmatic treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 16 years old
  • Long-term history of smoking
  • Pregnancy or lactating

Treatment and study plan

carbamazepine

Drug

Primary outcomes

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

Secondary outcomes

  1. At 3 months of treatment: PEFR before and after salbutamol inhalation;

  2. Difference in PEFR pm-am (in %); The daily (daytime and night-time) symptoms scores; Use of other antiasthmatic medication

Sponsors and collaborators

Lead sponsor

Centre of Chinese Medicine, Georgia

Other

Collaborators

  • Rea Rehabilitation Centre, Georgia

Registry information

Official study title

Randomized, Placebo Controlled, Double Blind Study of Carbamazepine in Treatment of Bronchial Asthma

Important dates

Study start
1999
Study completion
2000
First posted
Sep 21, 2005
Registry last updated
May 16, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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