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Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics (MAN05)

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ClinicalTrials.gov Identifier: NCT02682862
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sunny Jabbal, University of Dundee

Brief Summary:

Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced.

This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.


Condition or disease Intervention/treatment Phase
Asthma Drug: olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg Drug: olodaterol 2.5 mcg Phase 4

Detailed Description:

Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. Despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma.

Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. Research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking.

In view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke.

Participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between:

Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Ultra-long Acting Bronchodilator Therapy Assessed by Impulse Oscillometry in Smoking Asthmatics Taking Inhaled Corticosteroids
Study Start Date : August 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Smoking

Arm Intervention/treatment
Experimental: Spiolto Respimat
olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm
Drug: olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg
Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily
Other Name: Spiolto Respimat 2.5mcg/2.5mcg

Active Comparator: Striverdi Respimat
olodaterol 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm
Drug: olodaterol 2.5 mcg
Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
Other Name: Striverdi Respimat 2.5mcg




Primary Outcome Measures :
  1. Airway resistance at 5Hz (R5) [ Time Frame: 2-4 weeks ]
    measured by Impulse oscillometry (IOS)


Secondary Outcome Measures :
  1. RF [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Resonant Frequency

  2. X5 [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Reactance at 5Hz

  3. AX [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Reactance Area

  4. R5-R20 [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance

  5. R20 [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Resistance at 20Hz

  6. FEF25-75 pre and post challenge [ Time Frame: 2-4 weeks ]
    Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change)

  7. FVC pre and post challenge [ Time Frame: 2-4 weeks ]
    Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change)

  8. FEV1 pre and post challenge [ Time Frame: 2-4 weeks ]
    Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change)

  9. Mannitol PD30 [ Time Frame: 2-4 weeks ]
    Provocation dose of mannitol causing 30% increase in R5

  10. Mannitol RDR [ Time Frame: 2-4 weeks ]
    Response-Dose Ratio

  11. R5 at PD30 [ Time Frame: 2-4 weeks ]
    Airway Resistance at 5 Hertz at PD30

  12. Salbutamol recovery time following mannitol challenge [ Time Frame: 2-4 weeks ]
  13. Domiciliary PEF [ Time Frame: 2-4 weeks ]
    Peak Expiratory Flow

  14. ACQ [ Time Frame: 2-4 weeks ]
    Asthma Control Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily)
  • Current smoker
  • Forced Expiratory Volume in 1 second (FEV1) ≥ 60 % predicted
  • 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 significant respiratory diseases, in the opinion of the investigator, such as COPD or bronchiectasis.
  • An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required
  • Any clinically significant medical condition that may endanger the health or safety of the participant
  • Participation in another drug trial within 30 days before the commencement of the study
  • Pregnancy or lactation
  • Unable to comply with the procedures of the protocol
  • Unable or unwilling to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682862


Contacts
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Contact: Brian Lipworth, MD, Mb Chb 00441382383188 b.j.lipworth@dundee.ac.uk
Contact: Sunny Jabbal, Mb Chb 00441382383920 s.jabbal@dundee.ac.uk

Locations
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United Kingdom
Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Brian Lipworth, MD, Mb Chb    +441382383188    b.j.lipworth@dundee.ac.uk   
Contact: Sunny Jabbal, Mb Chb    00441382383920    s.jabbal@dundee.ac.uk   
Principal Investigator: Brian Lipworth, MD, Mb Chb         
Principal Investigator: Sunny Jabbal, Mb Chb         
Sponsors and Collaborators
University of Dundee
Investigators
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Principal Investigator: Sunny Jabbal, Mb Chb University of Dundee
Principal Investigator: Brian Lipworth, MD, Mb Chb University of Dundee

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Responsible Party: Sunny Jabbal, Clinical Research Fellow, University of Dundee
ClinicalTrials.gov Identifier: NCT02682862     History of Changes
Other Study ID Numbers: 2013RC06
2014-005317-23 ( EudraCT Number )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sunny Jabbal, University of Dundee:
tiotropium
olodaterol
smoker
cigarette
bronchodilator

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Tiotropium Bromide
Bronchodilator Agents
Olodaterol
Bromides
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants