Bioequivalence of SPARCs levalbuterol tartrate HFA 45 Âµg inhalation aerosol in subjects with asthma

Phase 1

Conditions: Health Condition 1: null- AsthamaHealth Condition 2: J459- Other and unspecified asthma

Registration Number: CTRI/2015/10/006271

Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

Men and non pregnant women asthma patients aged 18 to 65 years

-Patients with diagnosis of moderate to severe asthma (based on NAEPP guidelines) for at least 6 months prior to screening visit.

The patients with: Symptoms-Daily, Night time awakenings- moderate: > 1x/week but not nightly OR Severe: often 7x/week

-SABA use (other than for exercise induced bronchospasm)- Daily.

-Patients showing reversibility of levalbuterol tartrate -15% or more increase in FEV1, 30 min after inhalations of 2 puffs (90 Î¼g) of Xopenex HFA 45 Î¼g inhalation aerosol

-5.Baseline (at check in visit) FEV1 should not be less than 45% of predicted or vary by more than +12 % from screening visit FEV1 value

iv)Interference with Normal Activity- Some limitation

3. FEV1 40% to 70% (both inclusive) of predicted at screening

Exclusion Criteria

-Allergy or Significant history of hypersensitivity or idiosyncratic reactions or intolerance to levalbuterol tartrate , beta 2 receptor agonist drug, HFA and/or any related compounds etc

-Patients on oral corticosteroids

-Diagnosis of COPD

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1, FVC and PEFRTimepoint: 1 hour (Â± 10 min) prior to dosing. <br/ ><br>Post inhalation FEV1, FVC and PEFR will be done 3 times at 0.166 hrs <br/ ><br>(10 min), 0.25 hrs (15 min), 0.5 hrs (30 min), 1.0 hrs (60 min), 1.5 hrs <br/ ><br>(90 min), 2, 3, 4, 5 and 6 hour post dosing

Secondary Outcome Measures