A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436890
• Other study ID #: GRC 4039-204
• Secondary ID: 2011-000270-57
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2011
• Last updated: June 20, 2013
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. The patient provides written informed consent to participate in the study

2. Male or female patient aged 18 to 65 years

3. Documented diagnosis of asthma

4. Forced Expiratory Volume in One Second (FEV1) between 50% and 80% of the predicted value

5. Patient judged by the investigator to be in otherwise good stable health based on medical history, physical examination, and routine laboratory data

6. Female participants must have a negative pregnancy test at screening visit

7. 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:

1. Pregnant or lactating women

2. Female subjects on hormone replacement therapy or hormonal contraceptives

3. Suffering from relevant lung diseases (other than asthma) causing impairment in lung function

4. Past smoker with a history of =10 pack per year or current smoker

5. Recent change in the patient's usual asthma treatment

6. 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

7. Evidence of current or recent neoplastic disease

8. 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

9. Positive serology for an infectious disease (including hepatitis B or C) at screening and known case of human immunodeficiency virus [HIV]

10. Patients who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression

11. Clinically significant ECG Abnormality at baseline

12. Patients with documented or suspected or current history of alcohol and drug abuse

13. Patients who have undergone lung surgery in the previous year

14. Participation in an investigational drug trial during 30 days preceding screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Revamilast
Tablet. Low dose, Once daily for 12 weeks
• Revamilast
Medium dose, Once daily for 12 weeks
• Revamilast
High dose, Once daily for 12 weeks
• Placebo
Placebo tablet in triple dummy format, Once daily for 12 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals S.A.

Countries where clinical trial is conducted

Czech Republic,  India,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12		Baseline to 12 weeks	No
Secondary	Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12		baseline to 12 weeks	No
Secondary	Area under the curve of Forced Expiratory Volume in One Second (FEV1)		12 weeks	No
Secondary	Change in asthma day time symptom score from baseline to week 12		Baseline to 12 weeks	No
Secondary	Frequency and severity of asthma exacerbations during treatment period		12 weeks	No
Secondary	Change in investigator global impression from baseline to week 12	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.	Baseline to 12 weeks	No
Secondary	Change in patient global impression from baseline to week 12	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.	Baseline to 12 weeks	No
Secondary	Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12		Baseline to 12 weeks	No
Secondary	Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12		Baseline to 12 weeks	No