Efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma

• Conditions: Asthma; MedDRA version: 15.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-000520-18-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-03
• Last Update Posted: 9 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Male and female adult patients aged = 18 years and = 75 years.
3. Patients with diagnosis of persistent asthma (according to GINA guidelines updated 2011) for a period of at least 1 month prior to Visit 1.
4. Patients receiving daily treatment with ICS up to the maximum dose per day indicated in the package leaflet, in a stable regimen for = 4 weeks prior to Visit 101.
5. Patients must demonstrate an increase in FEV1 of = 12% and 200 mLs within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101.
6. Pre-dose FEV1 of = 40% and = 80% of the predicted normal value for the patient after withholding bronchodilators at Visit 101.
The above criteria for FEV1 (percent predicted normal value and the reversibility test) must be demonstrated after an appropriate washout period in Table 5-2.
7. An ACQ-5 score = 1.5 at Visit 101 and at Visit 201 (before randomization).
8. Body mass index (BMI) must be within the range of 18 to 40 kg/m2 inclusive.

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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

*Other protocol-defined exclusion criteria may apply

Study & Design

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