This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Boehringer Ingelheim Presents Efficacy Data For Tiotropium In Symptomatic Asthma Patients In Relation To Allergic Status

SAN ANTONIO, Feb. 23, 2013 /PRNewswire/ -- Boehringer Ingelheim presented today a new subset of data from the Phase III UniTinA-asthma program at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Antonio, Texas. In prespecified subgroups from two paired clinical trials, tiotropium delivered once daily via the Respimat® inhaler improved lung function and asthma control, as defined by a decrease in asthma exacerbations or worsening of asthma, in patients with poorly controlled asthma, irrespective of their allergic status. Patients included in the study remained symptomatic despite current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).

"Patients with asthma may respond differently to treatment based on their allergic status, therefore it is important to investigate new therapies in both allergic and non-allergic patients," said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. "The results of these trials show that tiotropium provides additional bronchodilation and reduces exacerbation rates in asthmatics who are uncontrolled on current therapy with at least ICS/LABA regardless of their allergic status, thus demonstrating its potential benefit for patients who need additional asthma control."

The two PrimoTinA-asthma studies were replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV 1 less than 80 percent predicted and asthma control questionnaire score of greater than or equal to 1.5, while on at least high dose ICS/LABA. A total of 912 patients were randomized to receive tiotropium 5 mcg or placebo in addition to usual care for 48 weeks. In addition to ICS/LABA, patients in the trials were permitted to receive additional background therapy, including antihistamines, anti-allergic agents, nasal steroids and omalizumab. The subgroup of patients with potentially allergic asthma was identified using three criteria: total serum immunoglobulin E (IgE), blood eosinophilia, or clinician judgment (CJ). Allergic status was positive if serum IgE was greater than 430 mcg/L, blood eosinophilia was greater than 0.6 x 10 9/L, or CJ was "yes."

Peak FEV 1 improved with tiotropium in Trial 1 irrespective of allergic status for IgE ( P=0.86) and eosinophilia ( P=0.46) and in Trial 2 for IgE ( P=0.98), eosinophilia ( P=0.18) and CJ ( P=0.29). Predose (trough) FEV 1 improved with tiotropium compared with placebo, irrespective of allergic status, across all criteria in Trial 1 (IgE, P=0.85; eosinophilia, P=0.83; and CJ, P=0.15) and Trial 2 (IgE, P=0.58; eosinophilia, P=0.38; and CJ, P=0.85). Pooled prespecified data analyses revealed that time to first severe asthma exacerbation and time to first asthma worsening were both increased with tiotropium compared with placebo, regardless of allergic status, based on the three criteria. In the overall study population, patients who received tiotropium had an improved time to first severe asthma exacerbation (risk reduction 21 percent; hazard ratio [HR] 0.79; P=0.03) and time to first asthma worsening (risk reduction 31 percent; HR 0.69; P<0.001), compared with patients receiving placebo.

Adverse events (AEs) were balanced between the allergic and non-allergic subgroups. The most frequently reported treatment-emergent AEs in both Phase III studies included asthma, peak expiratory flow (PEF) rate decrease and nasopharyngitis.  

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,890.18 -70.39 -0.42%
S&P 500 1,969.13 -9.21 -0.47%
NASDAQ 4,423.71 -25.8540 -0.58%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs