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Clinical Trials/CTRI/2017/03/008277
CTRI/2017/03/008277
Not yet recruiting
Phase 3

Comparative study of the efficacy and safety of Formoterol, dry powder capsules for inhalation, 12 µg and Foradil, inhalation powder, capsules, 12 µg in patients with partially controlled bronchial asthmaâ??

Rus Biopharm LLC0 sites136 target enrollmentTBD
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DrugsFormoterol fumarateForadil

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Rus Biopharm LLC
Enrollment
136
Status
Not yet recruiting
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
Rus Biopharm LLC

Eligibility Criteria

Inclusion Criteria

  • •1\.Male and female patients 18 to 70 years of age inclusive.
  • •2\.Diagnosis of persistent asthma established according to the GINA guidelines (2015\) not less than 6 months prior to the screening visit.
  • •3\.Need for combination bronchodilator therapy with long\-acting beta\-agonists in combination with inhaled glucocorticoids (IGC).
  • •4\.Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short\-acting
  • •beta\-agonists (SABA) as on\-demand therapy.

Exclusion Criteria

  • •1\.Patients for whom starting maintenance therapy for asthma has to be selected.
  • •2\.Contraindications for treatment with inhaled glucocorticoids, hypersensitivity to formoterol, salbutamol, or to any other ingredient included in the formulation of the investigational medicinal product, reference product, or salbutamol.
  • •3\.Galactose intolerance, lactase deficiency, or glucose \- galactose malabsorption.
  • •4\.Body mass index (BMI) \> 35 kg/m2\.
  • •5\.A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2015 version of the GOLD guidelines.

Outcomes

Primary Outcomes

Not specified

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