Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01156844
• Date of registration: 30/06/2010
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
• Scientific title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma
• Date of first enrolment: March 2010
• Target sample size: 191
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01156844
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

France, Germany, Jordan, Netherlands, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with a diagnosis of asthma and:

- Receiving daily treatment with inhaled corticosteroid in a regimen that has been
stable for at least a month prior to screening

- FEV1 =50% and =90% of predicted normal at screening

- An increase of =12% and =200 mL in FEV1 over prebronchodilator value within 30 minutes
after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion Criteria:

- Smoking history of = 10 years

- Patients with a diagnosis of COPD

- Patients who have been previously intubated for a severe asthma exacerbation/ attack

- Patients who have experienced a severe asthma attack/exacerbation requiring
hospitalization in the 6 months prior to screening

- Patients who have had an emergency room visit for an asthma attack/exacerbation within
6 weeks prior to screening

- Patients who have had a respiratory tract infection within 6 weeks prior to screening

- Patients with seasonal allergy whose asthma is likely to deteriorate during the study
period

- Patients with Type I or uncontrolled Type II diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Persistent Asthma

Intervention(s)

Drug: Indacaterol

Drug: Placebo to Indacaterol

Primary Outcome(s)

Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment [Time Frame: Baseline to week 2]

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment [Time Frame: Baseline, 0-24 hours post dose week 2]

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment [Time Frame: Baseline, 0 to 48 hours post dose week 2]

Secondary Outcome(s)

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment [Time Frame: Baseline, 0 to 12 hours post dose week 2]

Secondary ID(s)

CQAB149B2223

2010-018481-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01156844