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Additional Benefit of Montelukast in Patients with Both Asthma and Allergic Rhinitis. Analysis from the COMPACT Trial Price DB 1 , Swern AS 2 , Tozzi CA 2 , Philip G 2 , Polos P 2 , Yu Q 2 Originally presented at the World Allergy Organization Congress (XVIII ICACI),

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additional benefit of montelukast in patients with both asthma and allergic rhinitis

Additional Benefit of Montelukast in Patients with Both Asthma and Allergic Rhinitis

Analysis from the COMPACT Trial

Price DB1, Swern AS2, Tozzi CA2, Philip G2, Polos P2, Yu Q2

Originally presented at the World Allergy Organization Congress (XVIII ICACI),

Vancouver, BC, Canada - September 10, 2003

Abstract published in Allergy & Clinical Immunology International 2003,

Suppl. 1:29 abstract O-15-1

1 General Practice and Primary Care, University of Aberdeen, Aberdeen, UK

2 Merck & Co., Inc., Rahway, New Jersey, USA

slide2

Clinical Observation of Montelukast as a Partner Agent for Complementary Therapy

Price DB, Hernandez D, Magyar P et al. Thorax 2003;58:211-216

background
Background
  • Asthma and allergic rhinitis frequently coexist1
    • Rhinitis occurs in 75% of patients with allergic asthma and 80% of patients with non-allergic asthma
    • The same triggers (e.g., allergens) can cause rhinitis and asthma
    • Actively treated rhinitis is a risk factor for asthma exacerbations1
  • Upper and lower airways share a common & probably interconnected inflammatory process
    • Common inflammatory cells: mast cells, eosinophils, T-cells2
    • Common inflammatory mediators: histamine, leukotrienes, cytokines3
    • Bronchial challenge leads to nasal inflammation, and nasal challenge leads to bronchial inflammation3

1. Price D, Thomas M. ERS 2002

2. Bousquet J and the ARIA Workshop Group J Allergy Clin Immunol 2001;108(5):S147-S334

3. Management of Allergic Rhinitis and its Impact on Asthma (ARIA) Pocket Guide.A Pocket Guide for Physicians and Nurses. 2001

background1
Background
  • Optimal management of rhinitis may improve coexisting asthma1
  • Montelukast is approved to treat asthma and recently has gained approval for allergic rhinitis in several countries
    • Argentina, Czech Republic, Mexico, New Zealand, United States, etc.

1. Bousquet J and the ARIA Workshop Group J Allergy Clin Immunol 2001;108(5):S147-S334

compact study objectives
COMPACT Study Objectives

To determine the effect of:

  • Adding montelukast to inhaled budesonide 800 mg daily

versus

  • Doubling the dose of inhaled budesonide from 800 mg daily to 1600 mg daily
inclusion criteria for compact study
Inclusion Criteria for COMPACTStudy
  • Adults (15 to 70 years) with chronic asthma for >1 year
  • Using inhaled corticosteroids for >12 weeks
    • Dose range: 600 to 1200 µg/day (of BDP or equivalent)
  • Asthma not optimally controlled (judged by investigator)
  • Baseline FEV1 or PEF value >50% predicted
  • -agonist reversibility
    • >12% in FEV1 or >15% in PEF at randomisation visit, or
    • Predefined PEF variability >20%
  • Minimal level of daytime symptoms and b-agonist use during the 2 weeks pre-randomisation
slide7

Period II

Active treatment (12 weeks)

Double-blind

Period IRun-in (4 weeks)

Single-blind

n=448

Montelukast 10 mg once daily

+

Budesonide 400 µg twice daily

Budesonide 400 µg twice daily

Budesonide 800 µg twice daily

n=441

0

1

4

16

8

12

Weeks

Study Design

objective of this analysis
Objective of this Analysis
  • To determine if treatment with montelukast added to budesonide (400 g twice daily), compared with budesonide (800 g twice daily), provides additional benefit to patients with co-existing asthma and allergic rhinitis
statistical analysis
Statistical Analysis
  • All patients with a baseline and at least one on-treatment value were included in this intention-to-treat analysis
  • Treatment comparisons were based on an analysis of covariance (ANCOVA) model, with corresponding baseline value included as a covariate and treatment group as a factor
  • All analyses of patient subgroups were post hoc
definition of groups in analysis
Definition of Groups in Analysis
  • Asthma+AR

Patients with asthma and allergic rhinitis, defined by both positive patient history and confirmed physician diagnosis

  • Asthma–AR

Patients with asthma but without both a patient history and physician diagnosis of allergic rhinitis

patient demographic characteristics
Patient Demographic Characteristics

Asthma+AR Asthma–ARN=410 N=479

Age, years median (range) 43 (15-74) 45 (15-75)

Race, n (%) Caucasian 319 (77.8) 365 (76.2) Black 4 (1.0) 2 (0.4) Hispanic 46 (11.2) 82 (17.1) Other41 (10.0) 30 (6.3)

Gender, n (%) Male 171 (41.7) 184 (38.4) Female239 (58.3) 295 (61.6)

patient baseline characteristics
Patient Baseline Characteristics

Asthma+ARAsthma–AR

N=410 N=479

AM PEF

median (range) 381 (89-870) 360 (62-875)

Eosinophils

median (range)0.24 (0-1.59) 0.23 (0-2.12)

Using Rhinitis Meds Prestudyn (%) n (%)

Intranasal steroid (INS)14 (3.4) 9 (1.9)Antihistamines (A)41 (10.0) 15 (3.1)

Other treatments (O)12 (2.9) 10 (2.1)

INS or A or O 57 (13.9) 30 (6.3)

change in am pef total group
Change in AM PEF Total Group

p=0.36

Weeks

* Montelukast 10 mg once-daily along with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

change in am pef total group1
Change in AM PEFTotal Group

* Montelukast 10 mg once-daily along with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

change in am pef asthma ar patient group post hoc analysis

p<0.03

Change in AM PEFAsthma+AR Patient GroupPost Hoc Analysis

Weeks

* Montelukast 10 mg once-daily with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

change in am pef asthma ar patient group
Change in AM PEFAsthma+AR Patient Group

* Montelukast 10 mg once-daily along with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

change in am pef asthma ar patients using rhinitis meds post hoc analysis
Change in AM PEFAsthma+AR Patients: Using Rhinitis Meds§Post Hoc Analysis

p<0.02

Weeks

§ Intranasal steroids or antihistamines or other treatments for rhinitis

* Montelukast 10 mg once-daily along with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

change in am pef asthma ar patients using rhinitis meds
Change in AM PEFAsthma+AR Patients: Using Rhinitis Meds§

§ Intranasal steroids or antihistamines or other treatments for rhinitis

* Montelukast 10 mg once-daily along with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

percent increase in am pef in different ar subgroups
Percent Increase in AM PEFin Different AR Subgroups

Percentages calculated using LS mean for change and baseline mean

§ Intranasal steroids or antihistamines or other treatments for rhinitis

* Montelukast 10 mg once-daily along with budesonide 400 g twice-daily.

** Budesonide 800 g twice-daily

results
Results
  • Adding montelukast significantly improved AM PEF in patients who had both asthma and allergic rhinitis (defined by both patient history and physician diagnosis), versus doubling the dose of inhaled budesonide
    • Treatment effect was greatest in patients taking medications for rhinitis at randomization
  • Doubling the dose of budesonide was less effective for asthma than adding montelukast in patients with both allergic rhinitis and asthma
    • Patients with both allergic rhinitis and asthma – who were also taking medications for rhinitis – showed minimal improvement in AM PEF with doubling the budesonide dose
conclusion
Conclusion
  • In the subgroup ofpatients from the COMPACT study who had both asthma and allergic rhinitis, adding montelukast to budesonide provided greater benefit in reducing airflow obstruction, compared with doubling the dose of budesonide
acknowledgment
Acknowledgment

The authors express gratitude to the study centers and investigators:

  • Argentina: Baena-Cagnani CE, Lopez AM, Nannini LJ, Neffen H, Callejas O, Rey CA, Rojas R, Taborda J
  • Australia: Bryant D, Dennis C, Holmes P
  • Austria: Eckmayr J, Kummer F, Obermair H, Roger MG, Vetter N, Wanka W, Wild M, Wildner C, Zwick H
  • Belgium: Dierickx H, Mestdagh J, Rombouts L, Schatteman E, Schoofs H
  • Brazil: Fiterman J, Barreto SM
  • Canada: Laviolette M
  • China: Lin J, Luo W, Zhong NS, Zhou X
  • Colombia: Naranjo F
  • Finland: Rossi O, Toljamo T, Torkko M
  • Germany: Becker J, Beeh KM, Harnest U, Linnhoff A, Mikloweit P, Mitlehner W, Schmidtmann S, Schultebraucks R, Seevers C, Stutz P
  • Greece: Christaki P, Gaga A, Galanis N, Gourgoulianis G, Cratsiou C, Konstantopoulos S, Papadakis NE, Papageoriou G, Siafakas N
  • Hungary: Baliko Z, Berta G, Csontos Z, Herjavecz I, Kraszko P, Nekam K, Namenyi M, Magyar P, Szuks Z
  • Italy: Centanni S, Di Maria GU, Fabbri LM, Schmid G
  • Mexico: Acuna M, Hernandez D, Perez R, Salazar R
  • Netherlands: Aalbers R, Bantje T, Bax AJM, Creemers JPHM, Harreveld A, Van Kralingen K, Kuipers A, Luursema P, Van Noord J, Rijssenbeek-Nouwens LHM, Sinninghe Damst HEJ, Van Weelden BM, Wever AMJ
  • Norway: Bergmann A, Johansen B, Langaker KE
  • Portugal: Almeida J, Arrobas AM, Miranda MS, Segorbe AL
  • Romania: Radu JR, Stoicescu IP
  • Spain: Ercoreca IA, Hernandez JC, Olaguibel-Rivera JM, Pelaez A, Prieto-Andres JL, Reques FG, Rodriguez JR, Sanz CC
  • Sweden: Johansson G, Lind A, Lundback B, Spjuth A
  • Switzerland: Graf HJ, Gumowski P, Pons M, Spertini F
  • Taiwan: Chiang CD, Wang JH
  • UK: Barnes N, Corris P, O’Connor B, Dilworth P, Fahmy M, Fletcher P, James IB, Price DB
  • Venezuela: Montes De Oca MDC
slide24
This information is provided as a professional service by Merck & Co., Inc. The views expressed in this presentation reflect the experience and opinions of the authors and not necessarily that of Merck & Co., Inc. or any of its affiliates. For detailed prescribing information on any product discussed in this presentation, please consult the physician circular or instruction booklet issued by the manufacturer before initiating therapy or procedures.

Used with author permission.