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Completed

NCT Number: NCT02039050

Evaluation of Long-Acting Muscarinic Antagonists in COPD

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Research Group, University of Dundee

Dundee, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium

Drug

Aclidinium

Drug

Primary outcomes

  1. Change in trough R5 from baseline after chronic dosing

    Time frame: 4 to 6 weeks

Secondary outcomes

  1. Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)

    Time frame: 4 to 6 weeks

  2. Spirometry (FEV1, FEF25-75, FVC)

    Time frame: 4 to 6 weeks

  3. Relaxed VC (RVC) with RVC to FVC ratio

    Time frame: 4 to 6 weeks

  4. Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)

    Time frame: 4 to 6 weeks

  5. Domiciliary PIKO-6 measurements for FEV1 and FEV6

    Time frame: 4 to 6 weeks

  6. St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 4 to 6 weeks

  7. Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)

    Time frame: 4 to 6 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Almirall Limited

Registry information

Official study title

Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry

Acronym: MAN04

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 17, 2014
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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