A study to evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Indacaterol Maleate as a new formulation in the Concept1 device

• Conditions: Asthma; MedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001825-25-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Male and female patients with asthma, aged 18 or above, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2010) and who additionally meet the following criteria:
• Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for at least 4 weeks prior to screening.
• Patients with an FEV1 at screening and initial baseline of =50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a minimum washout of 48 hours for a long acting ß2-agonist or 7 days for
tiotropium/indacaterol. If appropriate washout has not been achieved when the patient attends for screening the Screening Part 1 assessments should be completed and the patient should return for Screening Part 2.
• Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their prebronchodilator value after inhaling a total of 400 µg of salbutamol (the reversibility test) as per ATS/ERS Task force: Standardisation of Lung Function Testing guidelines.
Reversibility will have to be demonstrated after an appropriate washout period as described in Section 3.1. The administration of salbutamol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. If the patient does not show reversibility this may be repeated once.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who require the use of = 12 puffs/24 hours of rescue medication for 48 hours between screening and randomization.
• Patients who have a decline in PEFR from the reference PEFR (taken at screening) of =30% for 5 of the 6 consecutive scheduled PEFR readings (includes readings taken at morning and evening) between screening and randomization.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified