NCT02741583

Brief Summary

prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

April 12, 2016

Last Update Submit

October 25, 2016

Conditions

Effect of High Altitude

Outcome Measures

Primary Outcomes (2)

  • daily peak-flow variability

    assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements

  • change in asthma control questionnaire score

    baseline to week 3 and 15

Secondary Outcomes (10)

  • forced expiratory volume in 1 second (FEV1)

    baseline to week 3 and 15

  • average peak flow over 2 days

    baseline to week 3 and 15

  • spirometric values (Forced vital capacity (FVC), FEV1/FVC)

    from baseline to week 3 and 15

  • asthma-related quality of life (AQLQ)

    from baseline to week 3 and 15

  • generic quality of life (Short-Form 36(SF-36))

    from baseline to week 3 and 15

  • +5 more secondary outcomes

Study Arms (2)

altitude rehabilitation program

EXPERIMENTAL

3 weeks rehabilitation program at high altitude (3200m)

Other: altitude rehabilitation program

rehabilitation program

ACTIVE COMPARATOR

3 weeks rehabilitation program at low altitude (760m)

Other: rehabilitation program

Interventions

altitude rehabilitation programOTHER

altitude exposure

altitude rehabilitation program
rehabilitation programOTHER

Rehabilitation at low altitude

rehabilitation program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with atopic or non-atopic Asthma for at least 3 months
  • partly controlled on regular or on demand inhaled therapy according to guidelines.
  • asthma variability in peak expiratory flow \> 10%/day and/or a reversible airflow obstruction in spirometry
  • History of asthma consisting of variable symptoms (cough, dyspnea, wheezing).

You may not qualify if:

  • Unstable and severely uncontrolled asthma needing systemic corticosteroids.
  • Need of continuous oral steroids for their asthma control
  • Heavy smokers (\>20 cigarettes per day)
  • Severe concomitant diseases preventing patients to adhere to the protocol and/or altitude exposure (severe metabolic, kidney- or liver disease, heart failure (ejection fracture \<50%).
  • Chronic lung diseases with a persistent FVC \< 60% an/or arterial oxygen saturation \<92%).
  • Severe mental- or musculoskeletal disorders
  • Pregnant or breast feeding women
  • Patient which are unable to comply with the study procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Saxer S, Schneider SR, Appenzeller P, Bader PR, Lichtblau M, Furian M, Sheraliev U, Estebesova B, Emilov B, Sooronbaev T, Bloch KE, Ulrich S. Asthma rehabilitation at high vs. low altitude: randomized parallel-group trial. BMC Pulm Med. 2019 Jul 24;19(1):134. doi: 10.1186/s12890-019-0890-y.

    PMID: 31340793DERIVED

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Silvia Ulrich Somaini, MD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 18, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

CH(1)