N/A
Completed N=200
Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients
Source: ClinicalTrials.gov NCT02331940 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Sleeping Oxygen Saturation — 94.4; 94.4 percentage of Oxygen Saturation — p=0.88
Summary
The aim of this study was 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleeping Oxygen Saturation |
94.4; 94.4 | 0.88 |
| PRIMARY Sleep Quality |
73.2; 79.1; 87.3; 85.3; 12.7; 14.7 | — |
| SECONDARY Sleepiness |
6.5; 6.1 | — |
| SECONDARY Hospitalization Rate |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged >=40 years old
- current or ex-smokers with a smoking history of at least 10 pack-years
- mild to moderate stable COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage I and II according to the 2010 GOLD guidelines (a post-bronchodilator forced expiratory volume in the first second (FEV1) ≥80% of predicted for stage I and 50% ≤ FEV1 450 ms at screening
- diabetes
- long-term oxygen therapy
- symptomatic prostatic hyperplasia
- bladder-neck obstruction
- moderate/severe renal impairment
- urinary retention
- narrow-angle glaucoma
- family or personal history of mental illness
- drug or alcohol abuse
- severe cognitive impairment
- concurrent oncological diseases
- history of narcolepsy or restless legs syndrome
- known history of alpha-1 antitrypsin deficiency
- participation in the active phase of a supervised pulmonary rehabilitation program
- hypersensitivity to any of the test ingredients
- history of adverse reactions to inhaled anticholinergics.
Data sourced from ClinicalTrials.gov (NCT02331940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.