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Clinical Trials/CTRI/2009/091/000109
CTRI/2009/091/000109
Completed
Phase 4

A study evaluating the therapeutic potential of low dose Roxithromycin therapy in patients of stable bronchial asthma.

Cipla India Ltd0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Cipla India Ltd
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Cipla India Ltd

Eligibility Criteria

Inclusion Criteria

  • •Asthma diagnosed according to GINA guidelines
  • •\-Airway reversibility \- increase of at least 12% from baseline and 200ml to inhaled 400mcg salbutamol 20mcg through a pMDI with Spacer or rotahaler within 15\-30 min.
  • •\-FEV1 \&\#8805;60% of the predicted normal
  • •\-Age \&\#8805;18 years males or females
  • •\-No asthma exacerbation during past one month
  • •\-On a stable dose of inhaled ICS for past 1 month.
  • •\-Non smokers
  • •\-Written informed consent
  • •\-Female subjects who are not menopausal must be willing to and actually use contraceptives method of proven efficacy.

Exclusion Criteria

  • •\-Unable to discontinue long\-acting bronchodilators including theophylline for 24 hours and short acting bronchodilators for 6 hours prior to onset on the study day.
  • •\-Radiological or clinical evidence of other pulmonary diseases, COPD.
  • •\-Subjects with the clinical evidence of heart failure or arrhythmias.
  • •\-Concurrent diseases likely to affect the study e.g. tuberculosis, bronchogenic carcinoma, pneumonia, ischaemic heart disease, liver disease etc.
  • •\-Subjects with history of asthma exacerbation in past 4 weeks
  • •\-Subjects who have taken oral corticosteroids in the previous 4 weeks, or who are taking them currently.
  • •\-Uncooperative subjects or subjects unable to perform lung functions.
  • •\-Participation in other clinical studies during the month prior to visit 1\.
  • •\-Subjects too ill as judged by the investigators to participate.
  • •\-Pregnant and lactating women.

Outcomes

Primary Outcomes

Not specified

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