Evaluation of Long-Acting Muscarinic Antagonists in COPD

Overview

In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients. In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry

Full Title of Study: “Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2015

Interventions

  • Drug: Tiotropium
  • Drug: Aclidinium

Arms, Groups and Cohorts

  • Active Comparator: Tiotropium
    • Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.
  • Experimental: Aclidinium
    • Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Clinical Trial Outcome Measures

Primary Measures

  • Change in trough R5 from baseline after chronic dosing
    • Time Frame: 4 to 6 weeks

Secondary Measures

  • Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)
    • Time Frame: 4 to 6 weeks
  • Spirometry (FEV1, FEF25-75, FVC)
    • Time Frame: 4 to 6 weeks
  • Relaxed VC (RVC) with RVC to FVC ratio
    • Time Frame: 4 to 6 weeks
  • Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)
    • Time Frame: 4 to 6 weeks
  • Domiciliary PIKO-6 measurements for FEV1 and FEV6
    • Time Frame: 4 to 6 weeks
  • St. George’s Respiratory Questionnaire (SGRQ)
    • Time Frame: 4 to 6 weeks
  • Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)
    • Time Frame: 4 to 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3). – On inhaled corticosteroids / long-acting beta agonists – FEV1 30-80% predicted and FEV1/FVC <70%. – Smoking history ≥10 pack-years. – Ability to give informed consent – Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being Exclusion Criteria:

  • Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis – A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required) – Any clinically significant medical condition that may endanger the health or safety of the participant – Known or suspected sensitivity to/intolerance of investigational medicinal product – Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma – Pregnancy or lactation – Unable to comply with the procedures of the protocol

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Dundee
  • Collaborator
    • Almirall Limited
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brian J Lipworth, Professor of Allergy and Pulmonology – University of Dundee
  • Overall Official(s)
    • Brina Lipworth, MD, Principal Investigator, University of Dundee
    • Arvind Deva Manoharan, MBChB, Principal Investigator, University of Dundee

Citations Reporting on Results

Manoharan A, Morrison AE, Lipworth BJ. Effects of Adding Tiotropium or Aclidinium as Triple Therapy Using Impulse Oscillometry in COPD. Lung. 2016 Apr;194(2):259-66. doi: 10.1007/s00408-015-9839-y. Epub 2016 Jan 13.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.