deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02331940

Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Tiotropium Respimat Soft Mist Inhaler Versus HandiHaler to Improve Sleeping Oxygen Saturation and Sleep Quality in COPD.

Sponsor: University of Crete

Updated 9 times since 2017 Last updated: Feb 12, 2017 Started: Mar 31, 2010 Primary completion: Dec 31, 2013 Completion: Sep 30, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Chronic Obstructive Pulmonary Disease, this trial is completed. The trial is conducted by University of Crete and has accumulated 9 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension \>60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.

Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension \>60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.

Status Flow

~Jan 2017 – ~May 2017 · 4 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2023 — Jul 2024 [monthly]

    Completed NA

  5. Dec 2022 — Jan 2023 [monthly]

    Completed NA

Show 4 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed NA

  2. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  3. May 2017 — Jun 2018 [monthly]

    Completed NA

  4. Jan 2017 — May 2017 [monthly]

    Completed NA

    First recorded

Mar 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Crete
Data source: University of Crete

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.