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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
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
Primary outcomes
-
At 3 months of treatment: Change from baseline of the PEFR (also %predicted); Number of patients without asthma symptoms
Secondary outcomes
-
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
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).
NCT00246922
Asthma, Bronchial Asthma
Osaka, Japan
View Trial DetailsEfficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).
NCT00242307
Asthma, Bronchial Asthma
Osaka, Japan
View Trial DetailsHealth-Related Quality of Life of Patients With Asthma During the Pandemic of COVID-19
NCT04613245
Asthma, Asthma Chronic
Cairo, Egypt
View Trial DetailsSafety, Tolerability, and Pharmacokinetics of PA9159 Inhalation Aerosol in Healthy Adult Subjects
NCT06916273
Asthma, Bronchial Asthma
Nanchang, Jiangxi, China
View Trial Details