A clinical trial to study the effects of Beclomethasone in patients with Asthma

Phase 3

Completed

• Conditions: Asthma

• Registration Number: CTRI/2011/11/002176
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is a randomized, open–label, comparative, non-Inferiority, multicenteric study. The study will be conducted in adult patients with a diagnosis of mild to moderate persistent asthma with an FEV1 of 60% to 80% of the predicted value. Study will enroll 280 patients across different centers from India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

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 ratio to receive either Beclomethasone Dipropionate 250 μg in HFA propelled MDI or Beclomethasone Dipropionate 250 μg in HFA propelled MDI (Clenil® HFA 250 μg Spray).

The primary objective of the study is to evaluate the effect of study drug on lung function as assessed by FEV1 after the therapy (12 weeks). Secondary objective includes Change in PEF, asthma symptoms, number of asthma exacerbations, average need for use of short acting β 2 agonists and safety. Patients will be followed for safety and efficacy assessment at week 4, 8 and 12 after start of therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-30
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Male or female patient aged between 18 to 70 years with clinical diagnosis of mild to moderate asthma 2.
• The patient provides written informed consent to participate in the study 3.
• FEV1 between 60% and 80% of the predicted value 4.
• Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter.
• Positive response to the reversibility test 6.
• Negative urine pregnancy test at screening visit, in women of child bearing age group and willing to use acceptable contraceptive measures during the study period or women who have been permanently sterilized or attained menopause.
• Male patients should use double barrier contraceptive measures.

Exclusion Criteria

• Inability to carry out pulmonary function testing 2.
• Chronic Obstructive Pulmonary Disease (COPD) 3.
• Pregnant or lactating women 4.
• Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 5.
• History of near fatal asthma exacerbation 6.
• Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks 7.
• Active smoker 8.
• Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study 9.
• Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, endocrinal, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma 10.
• History of Diabetes mellitus 11.
• Clinically significant ECG Abnormality at baseline 12.
• History of alcohol or drug abuse 13.
• Known history of HPA axis disease or malfunctioning 14.
• Patients who have undergone major surgery in the previous 4 weeks 15.
• Participation in an investigational drug trial within 3 months of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean difference between groups in FEV1 value at the End of Treatment Visit	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in asthma symptom score	12 weeks
Change in nocturnal asthma symptom	12 weeks
Change in morning PEF	12 weeks
Change in Diurnal variability of PEF	12 weeks
Number of asthma exacerbations	12 weeks
Change in evening PEF	12 weeks
Average need for use of short acting β 2 agonists	12 weeks

Trial Locations

Locations (32)

Amrutha Chest Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Ashwini Hospitals; 🇮🇳 Warangal, ANDHRA PRADESH, India

Asthma Bhawan; 🇮🇳 Jaipur, RAJASTHAN, India

Axon Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Calcutta National Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Chest Research Centre; 🇮🇳 Chennai, TAMIL NADU, India

Dr. K.K.Pandey’ Clinic; 🇮🇳 Delhi, DELHI, India

Dr. Khippal’s Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Dr. Vasavi Clinic; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Gowri Prasanna Diabetes and Heart Care Centre Diagnostic; 🇮🇳 Bangalore, KARNATAKA, India

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Amrutha Chest Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr K Mallikarjuna

Principal investigator

9848339259

mallikamrutha@yahoo.com