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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR SPIRIVA RESPIMAT


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All Clinical Trials for Spiriva Respimat

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01694771 ↗ Co-administration of Olodaterol Respimat® and Tiotropium Handihaler® Completed Boehringer Ingelheim Phase 3 2012-09-01 The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.
NCT01179347 ↗ Tiotropium Bromide in Cystic Fibrosis Completed Boehringer Ingelheim Phase 3 2010-09-01 To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.
NCT00981851 ↗ Interaction in Chronic Obstructive Pulmonary Disease Experiment Completed Radboud University N/A 2009-09-01 The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?
NCT00292448 ↗ A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD) Completed Boehringer Ingelheim Phase 2 2006-02-01 The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.
NCT00239447 ↗ Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD Completed Boehringer Ingelheim Phase 3 2002-11-01 Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
NCT00281567 ↗ Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD) Completed Boehringer Ingelheim Phase 3 2002-08-01 Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for Spiriva Respimat

Condition Name

84430012345678Pulmonary Disease, Chronic ObstructiveHealthyAsthmaCOPD[disabled in preview]
Condition Name for Spiriva Respimat
Intervention Trials
Pulmonary Disease, Chronic Obstructive 8
Healthy 4
Asthma 4
COPD 3
[disabled in preview] 0
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Condition MeSH

15139800246810121416Pulmonary Disease, Chronic ObstructiveLung DiseasesLung Diseases, ObstructiveChronic Disease[disabled in preview]
Condition MeSH for Spiriva Respimat
Intervention Trials
Pulmonary Disease, Chronic Obstructive 15
Lung Diseases 13
Lung Diseases, Obstructive 9
Chronic Disease 8
[disabled in preview] 0
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Clinical Trial Locations for Spiriva Respimat

Trials by Country

+
Trials by Country for Spiriva Respimat
Location Trials
United States 178
Italy 24
Canada 7
United Kingdom 5
Australia 3
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Trials by US State

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Trials by US State for Spiriva Respimat
Location Trials
South Carolina 8
California 7
Florida 7
Ohio 6
Arizona 6
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Clinical Trial Progress for Spiriva Respimat

Clinical Trial Phase

27.3%27.3%9.1%36.4%02345678Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Spiriva Respimat
Clinical Trial Phase Trials
Phase 4 6
Phase 3 6
Phase 2/Phase 3 2
[disabled in preview] 8
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Clinical Trial Status

74.1%11.1%7.4%7.4%02468101214161820CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for Spiriva Respimat
Clinical Trial Phase Trials
Completed 20
Unknown status 3
Not yet recruiting 2
[disabled in preview] 2
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Clinical Trial Sponsors for Spiriva Respimat

Sponsor Name

trials0123456789Boehringer Ingelheim3MPearl Therapeutics, Inc.[disabled in preview]
Sponsor Name for Spiriva Respimat
Sponsor Trials
Boehringer Ingelheim 9
3M 4
Pearl Therapeutics, Inc. 3
[disabled in preview] 4
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Sponsor Type

67.6%32.4%0-2024681012141618202224IndustryOther[disabled in preview]
Sponsor Type for Spiriva Respimat
Sponsor Trials
Industry 23
Other 11
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Spiriva Respimat: Clinical Trials, Market Analysis, and Projections

Introduction to Spiriva Respimat

Spiriva Respimat, developed by Boehringer Ingelheim, is a bronchodilator indicated for the treatment of chronic obstructive pulmonary disease (COPD) and moderate to severe persistent asthma in patients whose symptoms are not well controlled with inhaled corticosteroids. The drug contains tiotropium bromide, which works by relaxing the airway muscles to improve breathing.

Clinical Trials Overview

Efficacy and Safety Studies

Clinical trials have been conducted to evaluate the efficacy and safety of Spiriva Respimat in various patient populations. For instance, a randomized, double-blind, parallel group study compared the efficacy and safety of Spiriva Respimat to placebo and open-label Spiriva Respimat in subjects with persistent asthma. This 24-week study involved three different doses of PT001 (a comparable drug) and Spiriva Respimat, enrolling 1077 subjects aged 12 to 80 years[1].

Comparative Studies

Other studies have compared Spiriva Respimat with other treatments. For example, the OTEMTO 1 & 2 trials and the ENERGITO study presented at the European Respiratory Society (ERS) International Congress 2015, showed that Spiolto Respimat (a combination of tiotropium and olodaterol) provided significant quality of life improvements and lung function over Spiriva Respimat or placebo, and even over steroid-containing therapies (LABA/ICS FDC) in patients with moderate to severe COPD[4].

Mechanism of Action and Dosage

Spiriva Respimat works as a long-acting muscarinic antagonist (LAMA), inhibiting the muscarinic receptors in the airways, thereby reducing bronchospasm and improving lung function. The recommended dosage for Spiriva Respimat is 2.5 μg once daily, administered via the Respimat inhaler[3].

Market Analysis

Current Market Scenario

The global market for asthma and COPD therapeutics is projected to reach $44.1 billion by 2031, growing at a CAGR of 7.3% over the forecast period. Within this market, Spiriva Respimat remains a significant player, particularly in the COPD segment. However, the market is becoming increasingly competitive with the introduction of new products and the patent expiry of existing ones[2].

Competitive Landscape

Spiriva Respimat faces competition from other bronchodilators and combination therapies. For instance, GSK’s Incruse Ellipta and Boehringer’s Stiolto Respimat are expected to gain market share during the forecast period. Additionally, AstraZeneca’s Brimica Genuair and Eklira Genuair, along with Novartis’s Utibron Neohaler and Seebri Neohaler, are anticipated to show positive growth[2].

Regulatory and Patent Landscape

The patent landscape for Spiriva Respimat is crucial for its market positioning. While the drug itself has established a strong presence, the expiry of patents for other related products, such as Stiolto Respimat in 2022, could impact its market share. The report highlights that the companies are developing therapies that focus on novel approaches, which could challenge Spiriva Respimat’s dominance[3].

Market Projections

Forecasted Sales

The market forecast for Spiriva Respimat indicates continued relevance but with potential challenges. The report provides a detailed analysis of the forecasted sales data from 2024 to 2032, suggesting that while Spiriva Respimat will remain a key player, it will face significant competition from emerging therapies. The extensive research and incremental healthcare spending globally are expected to expand the market size, but new entrants and generic versions could impact its sales[3].

Impact of Generic Competition

The introduction of generic versions, such as the tiotropium bromide inhalation powder, could affect Spiriva Respimat’s market share. However, as seen in the CVS Caremark 2025 formulary changes, the brand version of Spiriva Respimat is often preferred due to limited generic competition and more aggressive rebates on branded products[5].

Emerging Therapies and Market Competition

New Market Entrants

New products like GSK’s Breo Ellipta and Nucala are poised to experience sales growth, potentially at the expense of established drugs like Advair, which has seen a decline due to negative publicity and patent expiry. These new entrants are likely to heighten competition in the crowded asthma and COPD therapeutics market[2].

Late-Stage Emerging Therapies

The report highlights that late-stage emerging therapies for asthma are expected to significantly impact the market. These therapies focus on novel approaches to treat and improve disease conditions, which could challenge the dominance of Spiriva Respimat and other established treatments[3].

Conclusion

Spiriva Respimat remains a vital treatment option for COPD and asthma, backed by robust clinical trials and a well-established market presence. However, the landscape is evolving with new competitors, generic versions, and emerging therapies. As the global market for asthma and COPD therapeutics continues to grow, Spiriva Respimat must navigate these challenges to maintain its market position.

Key Takeaways

  • Clinical Trials: Spiriva Respimat has been evaluated in various clinical trials, demonstrating its efficacy and safety in treating COPD and asthma.
  • Market Analysis: The global market for asthma and COPD therapeutics is growing, but Spiriva Respimat faces increasing competition from new products and generic versions.
  • Regulatory Landscape: Patent expiries and regulatory milestones will influence the market dynamics for Spiriva Respimat.
  • Market Projections: Forecasted sales indicate continued relevance but with potential challenges from emerging therapies and generic competition.
  • Emerging Therapies: New market entrants and late-stage emerging therapies are expected to significantly impact the market.

FAQs

What is Spiriva Respimat used for?

Spiriva Respimat is used to treat chronic obstructive pulmonary disease (COPD) and moderate to severe persistent asthma in patients whose symptoms are not well controlled with inhaled corticosteroids.

What is the mechanism of action of Spiriva Respimat?

Spiriva Respimat works as a long-acting muscarinic antagonist (LAMA), inhibiting the muscarinic receptors in the airways to reduce bronchospasm and improve lung function.

What are the key competitors of Spiriva Respimat in the market?

Key competitors include GSK’s Incruse Ellipta, Boehringer’s Stiolto Respimat, AstraZeneca’s Brimica Genuair and Eklira Genuair, and Novartis’s Utibron Neohaler and Seebri Neohaler.

How does the patent landscape affect Spiriva Respimat?

The patent landscape, including the expiry of patents for related products, could impact Spiriva Respimat’s market share and competition from generic versions.

What are the forecasted sales projections for Spiriva Respimat?

Forecasted sales data from 2024 to 2032 suggest that while Spiriva Respimat will remain relevant, it will face significant competition from emerging therapies and generic versions.

Sources

  1. AstraZeneca Clinical Trials: "Efficacy and Safety of PT001 to Placebo and Open-label Spiriva Respimat in Subjects With Persistent Asthma."
  2. iHealthcare Analyst: "Global Asthma and COPD Therapeutics Market $44.1 Billion by 2031."
  3. Research and Markets: "SPIRIVA RESPIMAT Market Size, Insight, and Forecast to 2032."
  4. Respiratory Therapy: "COPD Therapy Spiolto Respimat Superior to Spiriva, LABA/ICS."
  5. PSG Consults: "2025 Formulary Changes: CVS Caremark."

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