NCT02821130|Completed
Orkambi Exercise Study
Orkambi
Effects of Orkambi on Exertional Dyspnea, Exercise Performance, and Ventilatory Responses in Adults With Cystic Fibrosis
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Orkambi
Effects of Orkambi on Exertional Dyspnea, Exercise Performance, and Ventilatory Responses in Adults With Cystic Fibrosis
Sponsor study identifier
observational
11
1 country
1
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
Actual (reported)Study Completion
June 1, 2020
Actual (reported)Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly reported symptom in patients with cystic fibrosis (CF). A recent treatment option known as Orkambi, which combines the drugs lumacaftor and ivacaftor, may be used in patients with CF to help improve lung health. However, the effects of this combination therapy on dyspnea and exercise performance, a known predictor of survival in CF, are not clear. The investigators aim to understand the effects of Orkambi on these symptoms and to gain new insight into the potential health improvements in CF from using this treatment option.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2016
Actual (reported)July 2016
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2016
Actual (reported)December 2019
Actual (reported)June 1, 2020
Actual (reported)Change in iso-time dyspnea rating from baseline (visit 2) to visit 3 and 4 during constant-load exercise tests.
Dyspnea rating measured using the Borg 0-10 category ratio scale.
Parameters will be measured during 3 visits. Visit 2 will occur before the participants go on drug (Orkambi). Visit 3 and 4 will occur at 1 month and 3 months after initiating full dose of drug, respectively. All visits will be completed within 4 months.
Change from baseline cardio-respiratory responses during constant-load exercise tests (prior to Orkambi initiation to full dose) at 1 and 3 months after initiating full dose of Orkambi.
Parameters will be measured during 3 visits. Visit 2 will occur before the participants go on drug (Orkambi). Visit 3 and 4 will occur at 1 month and 3 months after initiating full dose of drug, respectively. All visits will be completed within 4 months.
Change from baseline chronic activity-related dyspnea (prior to Orkambi initiation to full dose) at 1 and 3 months after initiating full dose of Orkambi.
Parameters will be measured during 3 visits. Visit 2 will occur before the participants go on drug (Orkambi). Visit 3 and 4 will occur at 1 month and 3 months after initiating full dose of drug, respectively. All visits will be completed within 4 months.
Change from baseline quality of life (prior to Orkambi initiation to full dose) at 1 and 3 months after initiating full dose of Orkambi.
Parameters will be measured during 3 visits. Visit 2 will occur before the participants go on drug (Orkambi). Visit 3 and 4 will occur at 1 month and 3 months after initiating full dose of drug, respectively. All visits will be completed within 4 months.
Change from baseline physical activity (prior to Orkambi initiation to full dose) at 1 and 3 months after initiating full dose of Orkambi.
Parameters will be measured during 3 visits. Visit 2 will occur before the participants go on drug (Orkambi). Visit 3 and 4 will occur at 1 month and 3 months after initiating full dose of drug, respectively. All visits will be completed within 4 months.
Participants diagnosed with cystic fibrosis
The CF patients will be recruited from the St. Paul's Hospital UBC Adult CF Clinic.
UBC James Hogg Research Centre, St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
Quon BS, Ramsook AH, Dhillon SS, Mitchell RA, Boyle KG, Wilcox PG, Guenette JA. Short-term effects of Lumacaftor/Ivacaftor (Orkambi) on exertional symptoms, exercise performance, and ventilatory responses in adults with cystic fibrosis. Respir Res. 2020 Jun 1;21(1):135. doi: 10.1186/s12931-020-01406-z.
Jordan A Guenette, PhD
University of British Columbia - Centre for Heart Lung Innovation
11 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2016
First Posted
July 1, 2016
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Molecular Phenotypes for Cystic Fibrosis Lung Disease
Change from baseline pulmonary function measures (prior to Orkambi initiation to full dose) at 1 and 3 months after initiating full dose of Orkambi.
Parameters will be measured during 3 visits. Visit 2 will occur before the participants go on drug (Orkambi). Visit 3 and 4 will occur at 1 month and 3 months after initiating full dose of drug, respectively. All visits will be completed within 4 months.
Contact the study team to confirm eligibility.
Primary Completion
December 2019
Actual (reported)Study Completion
June 1, 2020
Actual (reported)Last Updated
November 17, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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