Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma
Information source: Centre of Chinese Medicine, Georgia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchial Asthma
Intervention: Carbamazepine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centre of Chinese Medicine, Georgia Official(s) and/or principal investigator(s): Merab Lomia, MD, PhD, Principal Investigator, Affiliation: "Rea" Rehabilitation Centre Manana Tchaia, MD, Study Director, Affiliation: Centre of Chinese Medicine
Summary
The purpose of this study was evaluation the efficacy of antiepileptic drug carbamazepine in
the treatment of mild-to-severe bronchial asthma.
Clinical Details
Official title: Randomized, Placebo Controlled, Double Blind Study of Carbamazepine in Treatment of Bronchial Asthma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms
Secondary outcome: At 3 months of treatment: PEFR before and after salbutamol inhalation;Difference in PEFR pm-am (in %); The daily (daytime and night-time) symptoms scores; Use of other antiasthmatic medication
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Website of Neuroasthma Group
Starting date: August 1999
Last updated: May 15, 2006
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