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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02682862
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Dundee

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date April 22, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
Airway resistance at 5Hz (R5) [ Time Frame: 2-4 weeks ]
measured by Impulse oscillometry (IOS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02682862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • RF [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Resonant Frequency
  • X5 [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Reactance at 5Hz
  • AX [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Reactance Area
  • R5-R20 [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance
  • R20 [ Time Frame: 2-4 weeks ]
    Impulse Oscillometry: Resistance at 20Hz
  • FEF25-75 pre and post challenge [ Time Frame: 2-4 weeks ]
    Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change)
  • FVC pre and post challenge [ Time Frame: 2-4 weeks ]
    Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change)
  • FEV1 pre and post challenge [ Time Frame: 2-4 weeks ]
    Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change)
  • Mannitol PD30 [ Time Frame: 2-4 weeks ]
    Provocation dose of mannitol causing 30% increase in R5
  • Mannitol RDR [ Time Frame: 2-4 weeks ]
    Response-Dose Ratio
  • R5 at PD30 [ Time Frame: 2-4 weeks ]
    Airway Resistance at 5 Hertz at PD30
  • Salbutamol recovery time following mannitol challenge [ Time Frame: 2-4 weeks ]
  • Domiciliary PEF [ Time Frame: 2-4 weeks ]
    Peak Expiratory Flow
  • ACQ [ Time Frame: 2-4 weeks ]
    Asthma Control Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics
Official Title  ICMJE Effects of Ultra-long Acting Bronchodilator Therapy Assessed by Impulse Oscillometry in Smoking Asthmatics Taking Inhaled Corticosteroids
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
  • Drug: olodaterol 2.5 mcg
    Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
    Other Name: Striverdi Respimat 2.5mcg
Study Arms  ICMJE
  • 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
    Intervention: Drug: olodaterol hydrochloride 2.5mcg, tiotropium bromide 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
    Intervention: Drug: olodaterol 2.5 mcg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 18, 2019)
17
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
16
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682862
Other Study ID Numbers  ICMJE 2013RC06
2014-005317-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Dundee
Study Sponsor  ICMJE University of Dundee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunny Jabbal, Mb Chb University of Dundee
Principal Investigator: Brian Lipworth, MD, Mb Chb University of Dundee
PRS Account University of Dundee
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP