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Historically, there have been few therapies developed for the treatment of chronic obstructive pulmonary disease (COPD), a life threatening, progressive obstructive respiratory disease that interferes with normal breathing and has detrimental effects on quality of life.

In the 25 years between 1982 and 2008 only a handful of drugs were approved for COPD2 . Those drugs included Boehringer Ingelheim’s Spiriva (tiotropium), a long-acting muscarinic antagonist (LAMA), and twice-daily inhaled fixed dose combinations (FDCs) of long acting beta 2 adrenoceptor agonist (LABA) plus inhaled corticosteroid (ICS). GlaxoSmithKline’s (GSK) Advair (fluticasone propionate + salmeterol) and AstraZeneca (AZ) Symbicort, (budesonide + formoterol) were initially approved for asthma and their label expansions for COPD in 2008 ushered in the use of FDC therapies for symptom relief and maintenance therapy in that indication. In the past decade, as COPD clinical development intensified, the focus shifted towards developing FDCs of two novel bronchodilators. Four recently approved FDCs were developed, as dry powder formulations, specifically for moderate to severe COPD patients, and aimed to deliver once-daily symptom relief and maintenance treatment.

In this report we provide insights from Citeline’s Pharmaprojects and Trialtrove data into how these FDCs are carving out distinctive niches and what pipeline status FDCs are poised to enter this now competitive market in the near future.

Highlights in this white paper include:

In this report, we provide insights from Citeline’s Pharmaprojects and Trialtrove data into how fixed-dose combinations (FDCs) of two novel bronchodilators are carving out distinctive niches and the probable pipeline status we will see as FDCs enter the now competitive market for chronic obstructive pulmonary disease (COPD).


  • A snapshot of approved COPD therapeutics including their characteristics, program sponsors and approval timelines
  • The scope and scale of clinical programs for recently approved FDCs for COPD
  • A global look at Phase II-III trials in the recently approved FDC programs for COPD
  • Accrual numbers and enrollment rates for Phase III COPD trials of recently approved FDCs, as well as primary endpoints and study design details 
  • A look to the future for this increasingly competitive active market

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