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

• Register: EUCTR
• Last refreshed on: 30 September 2013
• Main ID: EUCTR2012-000520-18-NL
• Date of registration: 16/07/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma
• Scientific title: A multicenter, randomized, double-blind, placebo controlled, 12-week treatment, parallel-group study to assess the efficacy, safety and pharmacokinetics of indacaterol acetate (75 and 150 µg o.d.) in patients with persistent asthma
• Date of first enrolment: 18/10/2012
• Target sample size: 330
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000520-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Bulgaria, Canada, Germany, Japan, Korea, Republic of, Netherlands, Poland, Slovakia

Contacts

• Name: Medical Department ICRO
• Affiliation: Novartis Pharma BV

• Name: Medical Department ICRO
• Affiliation: Novartis Pharma BV

Key inclusion & exclusion criteria

Inclusion criteria:
Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- Patients who are receiving ICS treatment in a stable regimen for greater than or equal to 4 weeks
- Patients with a pre-bronchodilator FEV1 value of greater than or equal to 40% and less than or equal to 80% of predicted normal value
- Patients who demonstrate an increase of greater than or equal to 12% and 200 mL in FEV1
- ACQ-5 score greater than or equal to 1.5

*Other protocol-defined inclusion criteria may apply

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Asthma
MedDRA version: 15.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: Indacaterol acetate delivered via Concept1
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: indacaterol acetate
Current Sponsor code: QAB149
Other descriptive name: indacaterol acetate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol acetate delivered via Concept1
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: indacaterol acetate
Current Sponsor code: QAB149
Other descriptive name: indacaterol acetate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: To demonstrate superiority of indacaterol acetate 75 or 150 µg to placebo with respect to 24 h postdose trough FEV1 after 12 weeks of treatment in patient with persistent asthma.

Secondary Objective: To demonstrate superiority of indacaterol acetate 75 or 150 µg to placebo with respect to ACQ-5.
To evaluate the bronchodilator effects of each dose of indacaterol acetate (75 and 150 µg) compared with placebo.
To evaluate the efficacy of indacaterol acetate (75 and 150 µg) compared with placebo in terms of asthma exacerbation-related parameters.
To evaluate the effect of each dose of indacaterol acetate (75 and 150 µg) compared with placebo on (pre-medication) morning and evening peak expiratory flow rate (PEFR).
To evaluate the effect of each dose of indacaterol acetate (75 and 150 µg) compared with placebo on rescue medication usage.
To assess the pharmacokinetics (PK) of each dose of indacaterol (75 and 150 µg).
To evaluate the efficacy of indacaterol acetate (75 and 150 µg) compared with placebo in terms of asthma exacerbation-related parameters.
To assess the safety and tolerability of each dose of indacaterol acetate (75 and 150 µg).

Primary end point(s): Trough Forced Expiratory Volume in one second (FEV1).

Outcome Measure Description: Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.

Timepoint(s) of evaluation of this end point: over 12 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: over 12 weeks

Secondary end point(s): Asthma Control Questionnaire 5 (ACQ-5).
Trough FEV1.
Forced vital capacity (FVC) at each timepoint.
FEV1/FVC at each timepoint.
Standadized FEV1 AUC(5 min – 4 h), (5 min – 1 h) and (1 h – 4 h).
Peak FEV1.
Morning and evening peak expiratory flow rate (PEFR).
The usage of rescue medication (short acting ß2-agonist).
Asthma Quality of Life Questionnaire (AQLQ(S)).
Adverse events, laboratory analysis, vital signs and ECG.
Morning and evening peak expiratory flow rate (PEFR).
Plasma Indacaterol concentrations at each timepoint.
Time to first asthma exacerbation (mild, moderate, severe, moderate or severe and any) during the 12 week treatment period.
The annual rate of asthma exacerbations (mild, moderate, severe, moderate or severe and any).
Duration of asthma exacerbations (mild, moderate, severe, moderate or severe and any).
The percentage of patients with at least one asthma exacerbation (mild, moderate, severe, moderate or severe and any).
Time to permanent study discontinuation due to asthma exacerbation.
The percentage of patients who permanently discontinued study due to asthma exacerbation.
Total amounts (in doses) of systemic corticosteroids used to treat asthma exacerbations.

Secondary ID(s)

CQMF149E2203

Source(s) of Monetary Support

Novartis Pharma Services AG