A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma - Full Text View

Purpose

Asthma is a common, chronic inflammatory disease of the bronchial airways, with a reported prevalence in most industrialized countries of between 5 to 10 % of the adult population. Asthma is clinically characterized by repeated episodes of wheezing, breathlessness, chest tightness, and coughing; usually in the presence of variable airflow obstruction that is often reversible either spontaneously or with treatment (The Global Initiative for Asthma (GINA), 2009).

Drug treatment of asthma has focused on anti-inflammatory therapy in all but the mildest, intermittent cases. Inhaled corticosteroids have been shown to be anti-inflammatory in asthma, but chronic use of these agents may be associated with a range of side effects, especially at high doses. In asthma, there remains a need for the development of novel anti-inflammatory therapies that are at least equally effective and possess a superior safety profile in comparison to corticosteroids.

This is a randomized, double-blind, triple dummy, placebo controlled, parallel group, dose ranging study. The study will be conducted in adult patients with a diagnosis of chronic persistent asthma with an Forced Expiratory Volume in one second(FEV1) of 50% to 80% of the predicted value. Study will enroll 448 patients globally (278 from India) across different centers.

Patients will be recruited after providing written informed consent. After screening and run in period, patient will be randomized (patient meeting randomization criteria) in 1:1:1:1 ratio to receive either one of the three dose regimens of revamilast or placebo.

The primary objective of the study is to evaluate the effect of revamilast on lung function as assessed by Forced Expiratory Volume in one second (FEV1) after the therapy (12 weeks). Secondary objective includes area under curve for FEV1, Change in asthma symptoms, patient / investigator's global assessments and safety. Patients will be followed for safety and efficacy assessment at week 1, 4, 8 12 and 14 after start of therapy.

Condition	Intervention	Phase
Asthma	Drug: Revamilast Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase II, 12-week Randomized, Double-blind, Triple Dummy, Parallel Group, Placebo-controlled, Dose Range Finding Study to Evaluate Safety, Tolerability and Efficacy of Revamilast in Patients With Chronic Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Glenmark Pharmaceuticals Ltd. India:

Primary Outcome Measures:

Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12 [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
Area under the curve of Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in asthma day time symptom score from baseline to week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
Frequency and severity of asthma exacerbations during treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in investigator global impression from baseline to week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
An investigator-rated test measured on a 7-point scale, used to rate change in a patient's condition over the course of the study.
Change in patient global impression from baseline to week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
A patient-rated test measured on a 7-point scale, used to rate change in a patient's condition over the course of the study.
Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	448
Study Start Date:	October 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low dose Low dose revamilast	Drug: Revamilast Tablet. Low dose, Once daily for 12 weeks
Experimental: Medium dose Medium dose Revamilast	Drug: Revamilast Medium dose, Once daily for 12 weeks
Experimental: High dose High dose Revamilast	Drug: Revamilast High dose, Once daily for 12 weeks
Placebo Comparator: Placebo Matching placebo in triple dummy format	Drug: Placebo Placebo tablet in triple dummy format, Once daily for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient provides written informed consent to participate in the study
Male or female patient aged 18 to 65 years
Documented diagnosis of asthma
Forced Expiratory Volume in One Second (FEV1) between 50% and 80% of the predicted value
Patient judged by the investigator to be in otherwise good stable health based on medical history, physical examination, and routine laboratory data
Female participants must have a negative pregnancy test at screening visit
Males must agree to use barrier contraception while on study medication and for 90 days after taking the last dose of study medication

Exclusion Criteria:

Pregnant or lactating women
Female subjects on hormone replacement therapy or hormonal contraceptives
Suffering from relevant lung diseases (other than asthma) causing impairment in lung function
Past smoker with a history of ≥10 pack per year or current smoker
Recent change in the patient's usual asthma treatment
Patients with risk factors for asthma exacerbation during the study, including (any of the following):
- Current requirement for > 8 puffs per day of reliever medication.
- Hospitalization for asthma
- Treatment with systemic corticosteroid therapy within 3 months
Evidence of current or recent neoplastic disease
Clinically significant cardiovascular, haematological, endocrine, neurological, gastrointestinal, psychiatric, metabolic, immunologic, infectious, hepatic, renal, gynaecological disease or other condition that the investigator considers detrimental to the patient's participation in the study or that may prevent the successful completion of the study
Positive serology for an infectious disease (including hepatitis B or C) at screening and known case of human immunodeficiency virus [HIV]
Patients who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression
Clinically significant ECG Abnormality at baseline
Patients with documented or suspected or current history of alcohol and drug abuse
Patients who have undergone lung surgery in the previous year
Participation in an investigational drug trial during 30 days preceding screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436890

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Locations

Czech Republic
HORNMED s.r.o.
Brno, Czech Republic
Sdružená pneumologická a anesteziologická ambulance
Jindřichův Hradec, Czech Republic
Private pulmonatory ambulance
Neratovice, Czech Republic
India
Kunal Institute of Medical Specialities Pvt. Ltd
Hyderabad, Andhra Pradesh, India
Narayana Medical College & Hospital
Nellore, Andhra Pradesh, India
Yashoda Hospital
Secunderabad, Andhra Pradesh, India
Vasavi Hospital and Research Centre
Hyderabad, Andra Pradesh, India, 500009
Saboo hospital and research centre
Hyderabad, Andra Pradesh, India, 500012
Rutuja Allergy , Chest and General Clinic
Ponda, Goa, India
Gujarat Pulmonary & Critical Care Clinic
Ahmedabad, Gujarat, India
Chest and Maternity Centre
Bangalore, Karnataka, India
Narayanan Hrudayalaya Hospital
Bangalore, Karnataka, India
M S Ramaiah Medical College & Teaching Hospital
Bangalore, Karnataka, India
Kasturba Medical College Hospital
Mangalore, Karnataka, India
Westfort Hi-tech Hospital Ltd
Thrissur, Kerala, India
Indore Chest Centre
Indore, Madhya Pradesh, India, 452001
Prince Aly Khan Hospital
Mumbai, Maharashtra, India, 400010
The Bhatia Hospital
Mumbai, Maharashtra, India
KRIMS Hospitals
Nagpur, Maharashtra, India, 440010
Getwell Hospital & Research Institute
Nagpur, Maharashtra, India, 440015
Chest Research Foundation
Pune, Maharashtra, India
Shwaas Center, Navkar Hospital
Jaipur, Rajastan, India, 302023
Asthma Bhawan
Jaipur, Rajasthan, India
Dr Khippal's Clinic
Jaipur, Rajasthan, India
Chennai Thoracic Research Institute
Chennai, Tamil Nadu, India
Christian Medical College
Vellore, Tamil Nadu, India
National Allergy Asthma Bronchitis Institute
Kolkata, West Bengal, India
T B and Chest Disease Hospital
Goa, India
MAMC & Associated Lok Nayak Hospitals
New Delhi, India, 110002
Poland
NZOZ 'Promedica'
Bialystok, Poland
Nzoz Clinica Vitae
Gdansk, Poland
Prywatna Praktyka Lekarska
Krakow, Poland
Landa Specjalistyczne Gabinety Lekarskie
Krakow, Poland
Prywatny Gabinet Specjalistyczny
Lodz, Poland
Cdt Medicus
Lubin, Poland
Centrum Alergologii Teresa Hofman
Poznan, Poland
Centrum Medyczne Lucyna Andrzej Dymek
Strzelce Opolskie, Poland
Russian Federation
State Healthcare Institution
Elektrostal, Russian Federation
Central Clinical Hospital of Russian Academy of Science
Moscow, Russian Federation
State Healthcare Institution of Moscow
Moscow, Russian Federation
State Educational Healthcare Institution
Saratov, Russian Federation
United Kingdom
London Chest Hospital Department of Respiratory Medicine
London, UK, United Kingdom

Sponsors and Collaborators

Glenmark Pharmaceuticals Ltd. India

Glenmark Pharmaceuticals SA

Investigators

Study Director:

Dr Ballari Brahmachari

Glenmark Pharmaceuticals Ltd

More Information

No publications provided

Responsible Party:	Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier:	NCT01436890 History of Changes
Other Study ID Numbers:	GRC 4039-204, 2011-000270-57
Study First Received:	September 14, 2011
Last Updated:	December 31, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Glenmark Pharmaceuticals Ltd. India:

Chronic Persistent Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013