Indacaterol trials

[Everett]

Hi Barbara--
I got your inquiry on indacaterol. If you go to ClinicalTrials.gov you will find a title "Comparison of Indacaterol and Tiotropium on Lung Function and related outcomes in patients with COPD (Invigorate). This study is active and recruiting candidates-participants. The sponsor is Novartis Pharmaceuticals and the indentifier code is NCT00845728. It is a Phase III study due to conclude in 2012. There are 325 study sites but unfortuntely and as usual none of them are in the USA thanks I'm sure to the infinite wisdom of our FDA physicians. Novartis probably wont let them get into their pockets. There are sites in Canada and Mexico for those close enough to go there and apply. I plan to try to get in to the one at Monterry, Mexico if I qualify.
You can contact Novartis Pharm. at +41-61-324-111 for more information. It really sounds promising but I don't know what my Dr S. will say to my participation in light of my bad go-round in December. I'm doing much better now and back at the office seeing patients. Happy days are here again da da da da da da da da
Spring cometh
Everett

 

[barbara]

Everett - This needs to be posted at COPDliving. I will copy and paste your reply there. So happy to hear you are feeling better. Thank you for the info.

 

[carmen868]

onbrez

hi - i was recently prescribed the inhaler onbrez - which is indacaterol maleate. said to have less side effects than seretide. am still on spiriva.
so far, seems a bit better.

 

[barbara]

That's good to hear Carmen.

 

[Kaye]

Indacaterol Research

http://respiratory-research.com/content/12/1/54/abstract

Research
Characterization of the bronchodilatory dose response to indacaterol in patients with chronic obstructive pulmonary disease using model-based approaches

Didier Renard, Michael Looby, Benjamin Kramer, David Lawrence, David Morris and Donald R Stanski



Respiratory Research 2011, 12:54 doi:10.1186/1465-9921-12-54

Published: 26 April 2011
Abstract (provisional)
Background
Indacaterol is a once-daily long-acting inhaled beta2-agonist indicated for maintenance treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD). The large inter-patient and inter-study variability in forced expiratory volume in 1 second (FEV1) with bronchodilators makes determination of optimal doses difficult in conventional dose-ranging studies. We considered alternative methods of analysis.

Methods
We utilized a novel modelling approach to provide a robust analysis of the bronchodilatory dose response to indacaterol. This involved pooled analysis of study-level data to characterize the bronchodilatory dose response, and nonlinear mixed-effects analysis of patient-level data to characterize the impact of baseline covariates.

Results
The study-level analysis pooled summary statistics for each steady-state visit in 11 placebo-controlled studies. These study-level summaries encompassed data from 7476 patients at indacaterol doses of 18.75-600 ug once daily, and showed that doses of 75 ug and above achieved clinically important improvements in predicted trough FEV1 response. Indacaterol 75 ug achieved 74% of the maximum effect on trough FEV1, and exceeded the midpoint of the 100-140 mL range that represents the minimal clinically important difference (MCID; [greater than or equal to]120 mL vs placebo), with a 90% probability that the mean improvement vs placebo exceeded the MCID. Indacaterol 150 ug achieved 85% of the model-predicted maximum effect on trough FEV1 and was numerically superior to all comparators (99.9% probability of exceeding MCID). Indacaterol 300 ug was the lowest dose that achieved the model-predicted maximum trough response. The patient-level analysis included data from 1835 patients from two dose-ranging studies of indacaterol 18.75-600 ug once daily. This analysis provided a characterization of dose response consistent with the study-level analysis, and demonstrated that disease severity, as captured by baseline FEV1, significantly affects the dose response, indicating that patients with more severe COPD require higher doses to achieve optimal bronchodilation.

Conclusions
Comprehensive assessment of the bronchodilatory dose response of indacaterol in COPD patients provided a robust confirmation that 75 ug is the minimum effective dose, and that 150 and 300 ug are expected to provide optimal bronchodilation, particularly in patients with severe disease.