NCT Number: NCT00327028
Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin (diphenine) in the treatment of bronchial asthma.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
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 diphenine 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 phenytoin (diphenine) efficacy in treatment of patients with bronchial asthma.
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 18 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 and FEV1
-
Number of patients without asthma symptoms
Secondary outcomes
-
At 3 months of treatment
-
FEV1 before and after salbutamol inhalation
-
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
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Phenytoin Efficacy in Bronchial Asthma Therapy
Important dates
- Study start
- 2005
- Study completion
- 2005
- First posted
- May 17, 2006
- Registry last updated
- Feb 19, 2009
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