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

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 ]


Enrollment:	273
Study Start Date:	October 2011
Study Completion Date:	April 2013
Primary Completion Date:	April 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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 42 Study Locations

Sponsors and Collaborators

Glenmark Pharmaceuticals Ltd. India

Glenmark Pharmaceuticals S.A.

Investigators


Study Director:	Dr Ballari Brahmachari	Glenmark Pharmaceuticals Ltd

More Information


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:	June 20, 2013
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 September 30, 2016