Study of Efficacy of Gabapentin in Therapy of Bronchial Asthma

NCT00153283 | Completed Phase 4

• 1 other identifier: LTP-0904-GP-0404
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether antiepileptic drug gabapentin is effective in the treatment of chronic asthma.

Conditions

Bronchial Asthma

Keywords

Bronchial asthma; Gabapentin; Antiepileptic drug; Efficacy

Outcome Measures

Primary Outcomes (1)

• At 3 months of treatment: Change from baseline of the FEV1 and PEFR (also %predicted); Number of patients without asthma symptoms

Secondary Outcomes (1)

• At 3 months of treatment: FEV1 before and after salbutamol inhalation; Difference in PEF pm-am (in %); The daily (daytime and night-time) symptoms scores; % of symptom free days during the treatment period; Use of other antiasthmatic medication

Interventions

Gabapentin DRUG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have given their informed consent before commencing the procedures specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.
• Males or females.
• Patient aged between 16 and 65 years.
• Out patients.
• Non smokers or ex-smokers, having stopped smoking \> 1 year.
• Patients with an established (i.e. at least one year) clinical history of asthma.
• Absence of long-term remissions of asthma (lasting more than 1 month)
• Poorly controlled asthma, due to various reasons.
• Patients with a FEV1 reversibility of at least 12% from initial level after 400 mcg salbutamol inhalation (4 puffs of salbutamol MDI, 100 mcg per puff). Patients whose FEV1 reversibility was 12% within the past 12 months are acceptable, providing that the records are available to the investigator.
• Patients able to swallow capsules, able to understand and complete diary cards and to record their PEFR using a peak-flow meter.

You may not qualify if:

• Long-term history of smoking (3 years and more)
• History or presence of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
• Patients with a recent history (\< 1 year) of myocardial infarction and/or (\< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
• History of cancer within the past 5 years.
• Patients with active tuberculosis with indication for treatment.
• Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or emphysema.
• Patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
• Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
• Pregnant or nursing women and sexually active women with childbearing potential not using a medically approved method of contraception.
• Patients unlikely, unable or unwilling to comply with the requirements of the protocol.

Sponsors & Collaborators

• Centre of Chinese Medicine, Georgia: lead
• Rea Rehabilitation Centre, Georgia: collaborator

Related Links

• Website of Neuroasthma Group
• Bronchial asthma as neurogenic paroxysmal inflammatory disease: a randomized trial with carbamazepine

MeSH Terms

Conditions

Asthma

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Merab Lomia, MD

  "Rea" Rehabilitation Centre

  PRINCIPAL INVESTIGATOR

• Tamara Tchelidze, MD

  CRO Evidence

  STUDY DIRECTOR

• Manana Tchaia, MD

  Centre of Chinese Medicine

  STUDY CHAIR

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: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2003
• Study Completion: April 1, 2004
• Last Updated: February 19, 2009

Record last verified: 2009-02