A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2009-010589-46-DE
• Date of registration: 21/04/2009
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma
• Scientific title: A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma
• Date of first enrolment: 20/05/2009
• Target sample size: 32
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010589-46
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

France, Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Non smoker male and female adult patients aged 18-75 years inclusive, who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening.
2. Patients with asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2008)
3. Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
4. BMI must be within the range 18-32 kg/m2 (inclusive)
5. Vital signs (after 3 minutes resting measured in the supine position) not considered by the Investigator to be indicative of a disorder which would make it unsafe for subject to participate in the study or require medical intervention.
6. Able to communicate well with the investigator and comply with the requirements of the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. A urine cotinine level greater then the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower).
2. Patients who have had previous intubation for a severe asthma attack / exacerbation
3. Patients who have had a severe asthma attack / exacerbation requiring hospitalization in the 6 months prior to screening.
4. Patients who have had an emergency room visit for an asthma attack / exacerbation within 6 weeks prior to screening or any time between screening and per-dose day 1.
5. Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and per-dose day 1
6. Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
7. Patients who require the use of =8 inhalations per day of the short-acting ß2-agonist (100 µg/90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from screening to randomization.
8. Patients diagnosed with COPD as defined by the GOLD guidelines (2008).
9. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active) or clinically significant bronchiectasis
10. Any patient with lung cancer or a history of lung cancer


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

Health Condition(s) or Problem(s) studied

persistent asthma
MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Intervention(s)

Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol [maleate]
CAS Number: 753498-25-8
Current Sponsor code: QAB149 [maleate]
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol [acetate]
CAS Number: 1000160-96-2
Current Sponsor code: QAB149 [acetate]
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol [xinafoate]
CAS Number: 1000160-97-3
Current Sponsor code: QAB149 [xinafoate]
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Secondary Objective: • To assess the bronchodilator effect of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma compared with placebo
• Morning and evening PEF measurements for indacaterol salts (see above) in comparison to placebo
• To assess day and night rescue medication usage for indacaterol salts (see above) in comparison to placebo
• To assess the safety and tolerability of indacaterol salts (see above) in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs
• To evaluate the incidence of post-inhalational cough and tolerability, as determined by the investigator and the patient, after administration of indacaterol salts (see above) in comparison to placebo
• To assess the pharmacokinetics of indacaterol after 7 days of treatment of orally inhaled indacaterol salts (see above) in patients with persistent asthma

Main Objective: To assess the bronchodilator effect of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma compared with placebo as measured by mean change in FEV1 from baseline to post-dose trough after 7 days of treatment. Trough is defined as the mean of FEV1 at 23 h 10 min and 23 h 45 min post-dose.

Primary end point(s): The primary endpoint is change from baseline to trough FEV1 after 7 days of treatment. Trough FEV1 is defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post dose.

Secondary ID(s)

CQAB149D2301