AsthmaNCT01727765

Inspiratory Muscle Training and Asthma

A study testing inspiratory muscle training in people with Asthma, run by University of Portsmouth at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a pilot study which will assess the feasibility of a follow on main study. This study will examine the impact of inspiratory muscle training on quality of life, rescue drug medication usage, and other markers of asthma in adult asthmatics in the UK. Read more about this study

Who is it for?: Ages 18 to 59 years
Conditions the study is for: Asthma
What is being tested?: inspiratory muscle training
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 2 sitesUnited Kingdom
Study dates: Feb 2014to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Asthma Control Questionnaire score of ≥ 1.5
10 mg or less of prednisolone (or equivalent) daily
Aged 18 to 59 years inclusive
Able to provide written informed consent

Who cannot join

Any significant heart or lung disease other than asthma including any previous history of pneumothorax
Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease) not controlled with treatment, making implementation of the protocol or interpretation of the study results difficult
Women who are pregnant
Forced expiratory volume in one second of less than 50% best or predicted
A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent amount)
Undertaken a structured program of inspiratory muscle training within the past three months
Currently a participant in another interventional study

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Respiratory Centre, Queen Alexandra Hospital, Cosham
Portsmouth, Hampshire, PO6 3LY
University of Portsmouth
Portsmouth, Hampshire, PO6 3LY

Other trials in United Kingdom

About this study

Official title: Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma

Conditions: Asthma
Being tested: inspiratory muscle training
Keywords: Asthma, inspiratory muscle training
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

inspiratory muscle trainingOther
Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H\&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.

Study groups in NCT01727765
Study group	Role	What they receive
Experimental	Experimental	6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength Receives: Other: inspiratory muscle training
Sham Comparator	Sham comparator	6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period. Receives: Other: inspiratory muscle training

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximal Inspiratory Mouth Pressure (MIP)
MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).
Measured: pre (after the 4 week run-in) and post 6 weeks of IMT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014May 2015

First posted16 Nov 2012 (estimated)
Study startFeb 2014
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01727765
Sponsor's protocol ID: IMT and Asthma
Status last verified: Oct 2019
First submitted: 7 Nov 2012
Last updated: 25 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma
ClinicalTrials.gov ID: NCT01727765
Acronym / sponsor ID: IMT and Asthma
Conditions: Asthma
Keywords: Asthma, inspiratory muscle training
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of PortsmouthUniversity, hospital or other
Collaborators: National Health Service, United Kingdom
Study start: Feb 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 16 Nov 2012 (estimated)
Results: Posted 25 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Other: inspiratory muscle training6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength
Sham Comparator	Sham comparator	Other: inspiratory muscle training6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Asthma Control Questionnaire score of ≥ 1.5
10 mg or less of prednisolone (or equivalent) daily
Aged 18 to 59 years inclusive
Able to provide written informed consent

Key exclusion criteria (7 listed)

Any significant heart or lung disease other than asthma including any previous history of pneumothorax
Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease) not controlled with treatment, making implementation of the protocol or interpretation of the study results difficult
Women who are pregnant
Forced expiratory volume in one second of less than 50% best or predicted
A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent amount)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
inspiratory muscle trainingBoth groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H\&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.	Other	Experimental, Sham Comparator

Primary outcome

Maximal Inspiratory Mouth Pressure (MIP)
Time frame: pre (after the 4 week run-in) and post 6 weeks of IMT
MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).

Results and safety

Results posted to the registry on 25 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	8	8
Sham Comparator	8	8

Primary outcome: Maximal Inspiratory Mouth Pressure (MIP)

Time frame: pre (after the 4 week run-in) and post 6 weeks of IMT. Mean (Standard Deviation). Unit: kPa

Measure	Experimental n = 8	Sham n = 8
MIP pre training	9.36 (2.63)	9.37 (2.90)
MIP post training	10.55 (2.72)	9.21 (2.66)

Population analysed: As this was a feasibility study, statistical analysis was not required

Adverse events

Time frame: 12 weeks. This encompassed the 4 week run-in period, 2 weeks for testing (one week pre IMT and 1 week post IMT) and 6 weeks for IMT.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Sham Comparator	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing inspiratory muscle training in people with Asthma, run by University of Portsmouth at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Inspiratory Mouth Pressure (MIP) (time frame: pre (after the 4 week run-in) and post 6 weeks of IMT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01727765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.